List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

To improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) in markets with limited competition, FDA is publishing a list, consistent with the methodology described below, of approved new drug application (NDA) drug products that are off-patent and off-exclusivity, and for which the FDA has not approved an ANDA referencing that NDA drug product.

Part I of the list identifies those drug products for which FDA could immediately accept an ANDA without prior discussion.

Part II identifies drug products for which ANDA development or approval may raise potential legal, regulatory, or scientific issues that should be addressed with the Agency prior to considering submission of an ANDA.

Sponsors wishing to pursue approval of ANDAs referencing drug products identified in Part II of this list generally should submit an initial inquiry to the Office of Generic Drugs at genericdrugs@fda.hhs.gov. Sponsors may be referred to the Office of New Drugs if the product is a biological product and/or if the product is not eligible for submission and/or approval as an ANDA, but may be considered for submission under another abbreviated approval pathway. Sponsors should identify the product’s established name and NDA number in their inquiry.

• Some products in Part II of the list may not be eligible for submission and/or approval as an ANDA via the 505(j) pathway; section 505(b)(2) of the FD&C Act may be an appropriate abbreviated approval pathway for such products.

• Some products in Part II of the list are biological products that are subject to the transition provision described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009.

• For other products in Part II of the list, there are regulatory or scientific complexities that may be overcome with additional information exchange between FDA and a prospective ANDA sponsor (e.g., there is no applicable product-specific guidance, the product is a complex mixture or imaging agent).

We have excluded any NDA drug products that have been approved within the past year, as it is too soon for an ANDA referencing such a product to have been approved.

FDA will update the list every six months. The current methodology for creating and reviewing the list is set forth at the bottom of the list. We welcome suggestions concerning the methodology, as well as suggestions for any NDA drug products that should be added to (or, in limited cases, removed from) the list. Please direct correspondence to genericdrugs@fda.hhs.gov, providing your name, e-mail address, phone number, NDA number, established name, and dosage form of any NDA drug product that should be added to or, in limited cases, removed from the list.

1

Part IIngredient Approved NDA Dosage FormACETAMINOPHEN N204767 SOLUTIONACETYLCHOLINE CHLORIDE N020213 FOR SOLUTIONACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE N019806 CAPSULEACYCLOVIR N021478 CREAMALBENDAZOLE N020666 TABLETALBUTEROL SULFATE N020503 AEROSOL, METEREDALENDRONATE SODIUM; CHOLECALCIFEROL N021762 TABLETALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K

N021559 INJECTABLE

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K

N021163 INJECTABLE

ALPROSTADIL N020700 SUPPOSITORYAMINO ACIDS N020015 INJECTABLEAMINO ACIDS N017766 INJECTABLEAMINO ACIDS N019438 INJECTABLEAMINO ACIDS N019374 INJECTABLEAMINO ACIDS N019492 INJECTABLEAMINO ACIDS N018429 INJECTABLEAMINO ACIDS N019398 INJECTABLEAMINO ACIDS N019018 INJECTABLEAMINO ACIDS N018931 INJECTABLEAMINO ACIDS N020849 INJECTABLEAMINO ACIDS N020041 INJECTABLEAMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

N018582 INJECTABLE

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

N020678 INJECTABLE

AMINO ACIDS; DEXTROSE N020734 INJECTABLEAMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE

N016822 INJECTABLE

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

N019437 INJECTABLE

2

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

N017673 INJECTABLE

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

N017789 INJECTABLE

AMINOCAPROIC ACID N015197 TABLET

AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE N050824CAPSULE, TABLET, CAPSULE, DELAYED RELEASE

AMPHOTERICIN B N050740 INJECTABLE, LIPOSOMALAPOMORPHINE HYDROCHLORIDE N021264 INJECTABLEAPRACLONIDINE HYDROCHLORIDE N019779 SOLUTION/DROPSARGATROBAN N206769 INJECTABLEARGATROBAN N203049 INJECTABLEARGININE HYDROCHLORIDE N016931 INJECTABLEARTEMETHER; LUMEFANTRINE N022268 TABLETARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

N022466 INJECTABLE

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K

N021265 INJECTABLE

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K

N021646 INJECTABLE

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E

N018920 FOR SOLUTION

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K

N021625 INJECTABLE

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K

N021643 INJECTABLE

ASPIRIN N200671 CAPSULE, EXTENDED RELEASEASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE N011483 CAPSULEATROPINE SULFATE N208151 SOLUTION/DROPS

3

ATROPINE SULFATE N206289 SOLUTION/DROPSATROPINE SULFATE N021146 SOLUTIONATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE N017744 TABLETATROPINE SULFATE; EDROPHONIUM CHLORIDE N019678 INJECTABLEAURANOFIN N018689 CAPSULEAZELAIC ACID N020428 CREAMAZTREONAM N050632 INJECTABLEBARIUM SULFATE N208036 FOR SUSPENSIONBARIUM SULFATE N208143 SUSPENSIONBARIUM SULFATE N208844 PASTEBENZOYL PEROXIDE; ERYTHROMYCIN N050769 GELBENZYLPENICILLOYL POLYLYSINE N050114 INJECTABLEBETAINE HYDROCHLORIDE N020576 FOR SOLUTIONBETAXOLOL HYDROCHLORIDE N019845 SUSPENSION/DROPSBOSENTAN N021290 TABLETBRINZOLAMIDE N020816 SUSPENSION/DROPSBUPRENORPHINE N021306 FILM, EXTENDED RELEASEBUSULFAN N009386 TABLETBUTENAFINE HYDROCHLORIDE N020524 CREAMCALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

N021703 INJECTABLE

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

N017512 SOLUTION

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

N020183 SOLUTION

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

N020577 INJECTABLE

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

N020000 INJECTABLE

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

N019367 INJECTABLE

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

N019634 INJECTABLE

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

N018895 INJECTABLE

CAPREOMYCIN SULFATE N050095 INJECTABLECARBOPROST TROMETHAMINE N017989 INJECTABLECARGLUMIC ACID N022562 TABLETCEFAZOLIN SODIUM N207131 SOLUTIONCEFAZOLIN SODIUM N050779 INJECTABLECEFEPIME HYDROCHLORIDE N050817 INJECTABLECEFIXIME N203195 CAPSULECEFTAZIDIME N050823 INJECTABLE

4

CEFUROXIME SODIUM N050643 INJECTABLECHLORAMBUCIL N010669 TABLETCHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

N012750 CAPSULE

CHLOROPROCAINE HYDROCHLORIDE N009435 INJECTABLECHROMIC CHLORIDE N018961 INJECTABLECITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE

N019481 SOLUTION

CITRIC ACID; UREA C-13 N021314FOR SOLUTION, TABLET, FOR SOLUTION

CLINDAMYCIN PHOSPHATE N050635 INJECTABLECLINDAMYCIN PHOSPHATE; TRETINOIN N050803 GELCLOCORTOLONE PIVALATE N017765 CREAMCLOZAPINE N203479 SUSPENSIONCROTAMITON N006927 CREAMCUPRIC CHLORIDE N018960 INJECTABLECYCLOPHOSPHAMIDE N203856 CAPSULECYCLOSPORINE N050625 CAPSULEDALFOPRISTIN; QUINUPRISTIN N050748 INJECTABLEDALTEPARIN SODIUM N020287 INJECTABLEDAPSONE N021794 GELDECITABINE N205582 POWDERDELAVIRDINE MESYLATE N020705 TABLETDESFLURANE N020118 LIQUIDDESVENLAFAXINE N204683 TABLET, EXTENDED RELEASEDESVENLAFAXINE N204150 TABLET, EXTENDED RELEASEDESVENLAFAXINE FUMARATE N205583 TABLET, EXTENDED RELEASEDEXAMETHASONE; TOBRAMYCIN N050616 OINTMENTDEXMEDETOMIDINE HYDROCHLORIDE N206628 SOLUTIONDEXTROSE N019445 INJECTABLEDEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE

N017385 INJECTABLE

DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE

N017610 INJECTABLE

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE

N019873 INJECTABLE

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE

N017484 INJECTABLE

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS

N019513 INJECTABLE

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

N017609 INJECTABLE

5

DEXTROSE; POTASSIUM CHLORIDE N017634 INJECTABLEDEXTROSE; POTASSIUM CHLORIDE N018371 INJECTABLE

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE N019630 INJECTABLE

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE N018365 INJECTABLE

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE N018876 INJECTABLE

DEXTROSE; SODIUM CHLORIDE N017606 INJECTABLEDEXTROSE; SODIUM CHLORIDE N017799 INJECTABLEDEXTROSE; SODIUM CHLORIDE N019631 INJECTABLE

DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE N011324 SOLUTION

DIAZEPAM N020648 GELDIAZOXIDE N017453 SUSPENSIONDIGOXIN N021648 ELIXIRDIGOXIN N020405 TABLETDIMERCAPROL N005939 INJECTABLEDINOPROSTONE N020411 INSERT, EXTENDED RELEASEDINOPROSTONE N017810 SUPPOSITORYDINOPROSTONE N019617 GELDISOPYRAMIDE PHOSPHATE N018655 CAPSULE, EXTENDED RELEASEDOCETAXEL N022234 INJECTABLEDOCETAXEL N201195 INJECTABLEDOCETAXEL N203551 INJECTABLEDOLASETRON MESYLATE N020624 INJECTABLEDOLASETRON MESYLATE N020623 TABLETDOPAMINE HYDROCHLORIDE N019615 INJECTABLEDOPAMINE HYDROCHLORIDE N019099 INJECTABLEDOXAZOSIN MESYLATE N021269 TABLET, EXTENDED RELEASEDOXORUBICIN HYDROCHLORIDE N050629 INJECTABLEDOXYCYCLINE HYCLATE N208253 CAPSULEDROSPIRENONE; ESTRADIOL N021355 TABLETECHOTHIOPHATE IODIDE N011963 FOR SOLUTIONEDETATE CALCIUM DISODIUM N008922 INJECTABLEEFLORNITHINE HYDROCHLORIDE N021145 CREAMEMEDASTINE DIFUMARATE N020706 SOLUTION/DROPSENFUVIRTIDE N021481 INJECTABLEENTECAVIR N021798 SOLUTIONERYTHROMYCIN ETHYLSUCCINATE N050207 GRANULEESOMEPRAZOLE STRONTIUM N202342 CAPSULE, DELAYED RELEASEESTRAMUSTINE PHOSPHATE SODIUM N018045 CAPSULEESTROGENS, CONJUGATED N004782 TABLETESTROGENS, CONJUGATED N010402 INJECTABLEETHANOLAMINE OLEATE N019357 INJECTABLEETHIONAMIDE N013026 TABLETETOPOSIDE PHOSPHATE N020457 INJECTABLE

6

EZOGABINE N022345 TABLETFENOFIBRATE N021612 CAPSULEFENOPROFEN CALCIUM N017604 CAPSULEFLUORESCEIN SODIUM N022186 INJECTABLEFLUOROURACIL N016988 CREAMFLUOXETINE HYDROCHLORIDE N202133 TABLET

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE N021077 POWDER

FOSFOMYCIN TROMETHAMINE N050717 FOR SUSPENSIONGUAIFENESIN; HYDROCODONE BITARTRATE N022424 SOLUTIONGUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

N022279 SOLUTION

HALCINONIDE N017556 CREAMHALCINONIDE N017824 OINTMENTHEPARIN SODIUM N019339 INJECTABLEHEPARIN SODIUM N018916 INJECTABLEHYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE N021956 TABLET, EXTENDED RELEASEHYDROCHLOROTHIAZIDE; SPIRONOLACTONE N012616 TABLETHYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE

N019261 SOLUTION/DROPS

HYDROXYUREA N016295 CAPSULEILOPROST N021779 SOLUTIONINDOMETHACIN N022536 INJECTABLEIODIXANOL N020351 INJECTABLEIOFLUPANE I-123 N022454 SOLUTIONLEUPROLIDE ACETATE N019732 INJECTABLELEUPROLIDE ACETATE N020011 INJECTABLELEUPROLIDE ACETATE N020263 INJECTABLELEUPROLIDE ACETATE N020708 INJECTABLELEUPROLIDE ACETATE N020517 INJECTABLELEVOLEUCOVORIN CALCIUM N208723 POWDERL-GLUTAMINE N021667 FOR SOLUTIONLINEZOLID N206473 SOLUTIONLODOXAMIDE TROMETHAMINE N020191 SOLUTION/DROPSLOMUSTINE N017588 CAPSULELOTEPREDNOL ETABONATE; TOBRAMYCIN N050804 SUSPENSION/DROPS

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

N019696 INJECTABLE

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

N017637 SOLUTION

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

N017586 INJECTABLE

7

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

N019024 SOLUTION

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

N019711 INJECTABLE

MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

N021910 SOLUTION

MAGNESIUM SULFATE N020488 INJECTABLEMAGNESIUM SULFATE N019316 SOLUTIONMAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

N204553 POWDER

MANGANESE CHLORIDE N018962 INJECTABLEMECHLORETHAMINE HYDROCHLORIDE N006695 INJECTABLEMEDROXYPROGESTERONE ACETATE N012541 INJECTABLEMEROPENEM N202106 POWDERMESALAMINE N020049 CAPSULE, EXTENDED RELEASEMESNA N020855 TABLETMETHACHOLINE CHLORIDE N019193 FOR SOLUTIONMETHADONE HYDROCHLORIDE N006383 POWDERMETHADONE HYDROCHLORIDE N021624 INJECTABLEMETHOHEXITAL SODIUM N011559 INJECTABLEMETHOTREXATE N204824 SOLUTIONMETRONIDAZOLE N020743 CREAMMIGLUSTAT N021348 CAPSULEMITOTANE N016885 TABLETMIVACURIUM CHLORIDE N020098 SOLUTIONMOMETASONE FUROATE N205641 AEROSOL, METEREDMORPHINE SULFATE N019916 INJECTABLEMORPHINE SULFATE N201517 SOLUTIONMORPHINE SULFATE N202515 INJECTABLEMORPHINE SULFATE N022207 TABLETMORPHINE SULFATE N020616 CAPSULE, EXTENDED RELEASEMOXIFLOXACIN HYDROCHLORIDE N205572 SOLUTIONMUPIROCIN CALCIUM N050703 OINTMENTNABILONE N018677 CAPSULENAFCILLIN SODIUM N050655 INJECTABLENAFTIFINE HYDROCHLORIDE N019356 GELNELARABINE N021877 INJECTABLENELFINAVIR MESYLATE N020779 TABLETNELFINAVIR MESYLATE N021503 TABLETNEOSTIGMINE METHYLSULFATE N203629 SOLUTIONNICARDIPINE HYDROCHLORIDE N022276 INJECTABLENICOTINE N020385 SPRAY, METEREDNITAZOXANIDE N021497 TABLETNITROGLYCERIN N020145 FILM, EXTENDED RELEASENITROGLYCERIN N021780 AEROSOL, METERED

8

OCTREOTIDE ACETATE N021008 INJECTABLEOLSALAZINE SODIUM N019715 CAPSULEOXACILLIN SODIUM N050640 INJECTABLEOXICONAZOLE NITRATE N020209 LOTIONOXYMETHOLONE N016848 TABLETPALONOSETRON HYDROCHLORIDE N207963 SOLUTIONPENICILLAMINE N019854 TABLETPENICILLAMINE N019853 CAPSULEPENICILLIN G BENZATHINE; PENICILLIN G PROCAINE N050138 INJECTABLEPENICILLIN G POTASSIUM N050638 INJECTABLEPENTAMIDINE ISETHIONATE N019887 FOR SOLUTIONPENTAZOCINE LACTATE N016194 INJECTABLEPENTETATE CALCIUM TRISODIUM N021749 SOLUTIONPENTETATE ZINC TRISODIUM N021751 SOLUTIONPENTOSAN POLYSULFATE SODIUM N020193 CAPSULEPHENYLEPHRINE HYDROCHLORIDE N204300 SOLUTIONPHENYLEPHRINE HYDROCHLORIDE N207926 SOLUTION/DROPSPHENYLEPHRINE HYDROCHLORIDE N203826 SOLUTIONPHYTONADIONE N010104 TABLETPODOFILOX N020529 GELPOLIDOCANOL N021201 SOLUTIONPOLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS

N019011 FOR SOLUTION

POTASSIUM CHLORIDE N206814 SOLUTIONPOTASSIUM CHLORIDE N208019 FOR SOLUTIONPOTASSIUM CHLORIDE; SODIUM CHLORIDE N017648 INJECTABLEPOVIDONE-IODINE N018634 SOLUTION/DROPSPRALIDOXIME CHLORIDE N018986 INJECTABLEPRALIDOXIME CHLORIDE N014134 INJECTABLEPRAZIQUANTEL N018714 TABLETPROCARBAZINE HYDROCHLORIDE N016785 CAPSULEPROGESTERONE N020701 GELPYRIDOSTIGMINE BROMIDE N015193 SYRUPPYRIMETHAMINE N008578 TABLETQUINIDINE GLUCONATE N007529 INJECTABLERABEPRAZOLE SODIUM N204736 CAPSULE, DELAYED RELEASERITONAVIR N020659 SOLUTIONROPIVACAINE HYDROCHLORIDE N020533 SOLUTIONSAQUINAVIR MESYLATE N020628 CAPSULESAQUINAVIR MESYLATE N021785 TABLETSELEGILINE HYDROCHLORIDE N021479 TABLET, ORALLY SILDENAFIL CITRATE N203109 FOR SUSPENSIONSODIUM ACETATE ANHYDROUS N018893 INJECTABLESODIUM CHLORIDE N202832 INJECTABLESODIUM CHLORIDE N019319 SOLUTION FOR SLUSHSODIUM CHLORIDE N018897 INJECTABLE

9

SODIUM CHLORIDE N019635 INJECTABLESODIUM CHLORIDE N021569 INJECTABLESODIUM IODIDE I-131 N021305 CAPSULESODIUM IODIDE I-131 N021305 SOLUTIONSODIUM IODIDE I-131 N016515 SOLUTIONSODIUM IODIDE I-131 N016517 CAPSULESODIUM LACTATE N018947 INJECTABLESODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

N018892 INJECTABLE

SORBITOL N017863 SOLUTIONSORBITOL N016741 SOLUTIONSOTALOL HYDROCHLORIDE N022306 SOLUTIONSTREPTOZOCIN N050577 INJECTABLESUCRALFATE N019183 SUSPENSIONTAZAROTENE N021184 CREAMTAZAROTENE N020600 GELTESTOSTERONE N020489 FILM, EXTENDED RELEASETETRACAINE HYDROCHLORIDE N208135 SOLUTIONTHIOGUANINE N012429 TABLETTIAGABINE HYDROCHLORIDE N020646 TABLETTIOPRONIN N019569 TABLETTOREMIFENE CITRATE N020497 TABLETTRAMADOL HYDROCHLORIDE N022370 CAPSULE, EXTENDED RELEASETRETINOIN N020475 GELTRIAMCINOLONE HEXACETONIDE N016466 INJECTABLETRIAMTERENE N013174 CAPSULETRIENTINE HYDROCHLORIDE N019194 CAPSULETRIMETHOPRIM HYDROCHLORIDE N074973 SOLUTIONTRIPTORELIN PAMOATE N021288 INJECTABLETRIPTORELIN PAMOATE N022437 INJECTABLETRIPTORELIN PAMOATE N020715 INJECTABLETROMETHAMINE N013025 INJECTABLETRYPAN BLUE N022278 SOLUTIONTRYPAN BLUE N021670 SOLUTIONVANCOMYCIN HYDROCHLORIDE N050671 INJECTABLEVERAPAMIL HYDROCHLORIDE N019614 CAPSULE, EXTENDED RELEASEVERTEPORFIN N021119 INJECTABLEVIGABATRIN N020427 TABLETZILEUTON N020471 TABLETZIPRASIDONE MESYLATE N020919 INJECTABLEZOLEDRONIC ACID N204016 SOLUTION

10

Part IIIngredient Approved NDA Dosage FormACETOHYDROXAMIC ACID N018749 TABLETALBUMIN IODINATED I-125 SERUM N017836 INJECTABLEALBUMIN IODINATED I-131 SERUM N017837 INJECTABLEALITRETINOIN N020886 GELALPROSTADIL N020649 INJECTABLEALPROSTADIL N021212 INJECTABLEALPROSTADIL N020379 INJECTABLEALTRETAMINE N019926 CAPSULEAMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL

N200656 EMULSION

ATROPINE N017106 INJECTABLEATROPINE; PRALIDOXIME CHLORIDE N021983 INJECTABLEBACLOFEN N022462 INJECTABLEBECLOMETHASONE DIPROPIONATE MONOHYDRATE N019389 SPRAY, METEREDBERACTANT N020032 SUSPENSIONBEXAROTENE N021056 GELBUDESONIDE N205613 AEROSOL, FOAMCALCITRIOL N022087 OINTMENTCALFACTANT N020521 SUSPENSIONCARMUSTINE N020637 IMPLANTCARMUSTINE N017422 INJECTABLECHLORHEXIDINE GLUCONATE N020774 TABLETCHLOROTHIAZIDE N011870 SUSPENSIONCIPROFLOXACIN HYDROCHLORIDE N020369 OINTMENTCIPROFLOXACIN HYDROCHLORIDE N021918 SOLUTION/DROPS

CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE N020805 SUSPENSION/DROPS

COLESTIPOL HYDROCHLORIDE N017563 GRANULECOLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE

N050356 SUSPENSION/DROPS

COPPER N018680 INTRAUTERINE DEVICECORTICORELIN OVINE TRIFLUTATE N020162 INJECTABLECORTICOTROPIN N008372 INJECTABLECYSTEAMINE BITARTRATE N020392 CAPSULECYTARABINE N021041 INJECTABLE, LIPOSOMALDESIRUDIN RECOMBINANT N021271 INJECTABLEDESMOPRESSIN ACETATE N020355 SPRAY, METEREDDIATRIZOATE MEGLUMINE N010040 INJECTABLEDIATRIZOATE MEGLUMINE N010040 SOLUTIONDIHYDROERGOTAMINE MESYLATE N020148 SPRAY, METEREDDOXEPIN HYDROCHLORIDE N020126 CREAMDOXYCYCLINE CALCIUM N050480 SUSPENSIONDOXYCYCLINE HYCLATE N050751 SYSTEM, EXTENDED RELEASEERYTHROMYCIN N050584 OINTMENT

11

ERYTHROMYCIN N050611 TABLET, COATED PARTICLESESTRADIOL N022038 GELESTRADIOL N020472 INSERT, EXTENDED RELEASEESTRADIOL N021166 GEL, METEREDESTRADIOL N020655 FILM, EXTENDED RELEASEESTRADIOL ACETATE N021367 INSERT, EXTENDED RELEASEESTRADIOL HEMIHYDRATE N021371 EMULSIONESTRADIOL; LEVONORGESTREL N021258 FILM, EXTENDED RELEASEESTRADIOL; NORETHINDRONE ACETATE N020870 FILM, EXTENDED RELEASEESTROGENS, CONJUGATED N020216 CREAMESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE

N020527 TABLET

ETHOTOIN N010841 TABLETFERRIC HEXACYANOFERRATE(II) N021626 CAPSULEFERRIC PYROPHOSPHATE CITRATE N206317 SOLUTIONFERRIC PYROPHOSPHATE CITRATE N208551 FOR SOLUTIONFLUNISOLIDE N021247 AEROSOL, METEREDFLUOCINOLONE ACETONIDE N020001 SHAMPOOFLUOROMETHOLONE N019216 SUSPENSION/DROPSFLUOROMETHOLONE N017760 OINTMENTFLUOROMETHOLONE ACETATE N019079 SUSPENSION/DROPSFLURANDRENOLIDE N012806 CREAMFLURANDRENOLIDE N012806 OINTMENTFLURANDRENOLIDE N016455 TAPEFLUTICASONE PROPIONATE N020833 POWDERFOLLITROPIN ALFA/BETA N021765 INJECTABLEGADOBENATE DIMEGLUMINE N021358 INJECTABLEGADOBENATE DIMEGLUMINE N021357 INJECTABLEGADOBUTROL N201277 SOLUTIONGADODIAMIDE N020123 INJECTABLEGADODIAMIDE N022066 INJECTABLEGADOPENTETATE DIMEGLUMINE N021037 INJECTABLEGADOPENTETATE DIMEGLUMINE N019596 INJECTABLEGADOTERIDOL N020131 INJECTABLEGADOTERIDOL N021489 INJECTABLEGADOVERSETAMIDE N020975 INJECTABLEGADOVERSETAMIDE N020937 INJECTABLEGADOVERSETAMIDE N020976 INJECTABLEGALLIUM CITRATE GA-67 N018058 INJECTABLEGALLIUM CITRATE GA-67 N017478 INJECTABLEGANCICLOVIR N022211 GELGENTAMICIN SULFATE; PREDNISOLONE ACETATE N050586 SUSPENSION/DROPSGENTAMICIN SULFATE; PREDNISOLONE ACETATE N050612 OINTMENTGLUCAGON HYDROCHLORIDE N201849 POWDERGLUCAGON HYDROCHLORIDE RECOMBINANT N020918 INJECTABLEGLUCAGON RECOMBINANT N020928 INJECTABLEGONADOTROPIN, CHORIONIC N017016 INJECTABLE

12

GUANIDINE HYDROCHLORIDE N001546 TABLETHISTRELIN ACETATE N021732 IMPLANTHYALURONIDASE N021665 INJECTABLEHYALURONIDASE N021640 INJECTABLEHYDROCORTISONE ACETATE N017351 AEROSOL, METEREDHYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

N050218 CREAM

HYDROCORTISONE PROBUTATE N020453 CREAMHYDROXOCOBALAMIN N022041 INJECTABLEHYDROXYPROPYL CELLULOSE N018771 INSERTIMIGLUCERASE N020367 INJECTABLEINDIUM IN-111 CHLORIDE N019862 INJECTABLEINDIUM IN-111 CHLORIDE N019841 INJECTABLEINDIUM IN-111 OXYQUINOLINE N019044 INJECTABLEINDIUM IN-111 PENTETATE DISODIUM N017707 INJECTABLEINDIUM IN-111 PENTETREOTIDE KIT N020314 INJECTABLEINSULIN HUMAN N018780 INJECTABLE; SOLUTIONINSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

N021017 INJECTABLE

INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT

N021018 INJECTABLE

INSULIN LISPRO RECOMBINANT N020563 INJECTABLEIOBENGUANE SULFATE I-123 N022290 SOLUTIONIOHEXOL N018956 INJECTABLEIOHEXOL N018956 SOLUTIONIOHEXOL N205383 FOR SOLUTIONIOHEXOL N020608 SOLUTIONIOPROMIDE N021425 INJECTABLEIOPROMIDE N020220 INJECTABLEIOTHALAMATE MEGLUMINE N013295 INJECTABLEIOTHALAMATE MEGLUMINE N017057 SOLUTIONIOTHALAMATE MEGLUMINE N016983 INJECTABLEIOTHALAMATE SODIUM I-125 N017279 INJECTABLEIOVERSOL N019710 INJECTABLEIOVERSOL N020923 INJECTABLEIRON DEXTRAN N040024 INJECTABLEIRON DEXTRAN N017441 INJECTABLEIRON DEXTRAN N017807 INJECTABLEIRON SUCROSE N021135 INJECTABLEISOCARBOXAZID N011961 TABLETISONIAZID; PYRAZINAMIDE; RIFAMPIN N050705 TABLETISOSORBIDE DINITRATE N019790 CAPSULE, EXTENDED RELEASELEUPROLIDE ACETATE; NORETHINDRONE ACETATE N203696 INJECTABLE, TABLETLEVOTHYROXINE SODIUM N021924 CAPSULELIDOCAINE; PRILOCAINE N021451 GELLIOTRIX (T4;T3) N016807 TABLETLOTEPREDNOL ETABONATE N020803 SUSPENSION/DROPS

13

LOTEPREDNOL ETABONATE N202872 GELLOTEPREDNOL ETABONATE N200738 OINTMENTLOTEPREDNOL ETABONATE N020583 SUSPENSION/DROPSMAFENIDE ACETATE N016763 CREAMMANNITOL N016772 SOLUTIONMECASERMIN RECOMBINANT N021839 INJECTABLEMENOTROPINS (FSH;LH) N021663 INJECTABLEMETHOXSALEN N020969 INJECTABLEMETHSUXIMIDE N010596 CAPSULEMETYRAPONE N012911 CAPSULEMETYROSINE N017871 CAPSULEMORPHINE SULFATE N019999 INJECTABLEMORPHINE SULFATE N018565 INJECTABLENAFARELIN ACETATE N019886 SPRAY, METEREDNATAMYCIN N050514 SUSPENSIONNESIRITIDE RECOMBINANT N020920 FOR SOLUTIONNICOTINE N020714 INHALANTNITAZOXANIDE N021498 FOR SUSPENSIONNITISINONE N021232 CAPSULENITROGLYCERIN N021359 OINTMENTOXYTOCIN N018261 INJECTABLEOXYTOCIN N018248 INJECTABLEPANCRELIPASE (AMYLASE;LIPASE;PROTEASE) N022175 CAPSULE, DELAYED RELEASEPANCRELIPASE (AMYLASE;LIPASE;PROTEASE) N022222 CAPSULE, DELAYED RELEASEPANCRELIPASE (AMYLASE;LIPASE;PROTEASE) N022523 CAPSULE, DELAYED RELEASEPANCRELIPASE (AMYLASE;LIPASE;PROTEASE) N022542 TABLETPEGADEMASE BOVINE N019818 INJECTABLEPEGAPTANIB SODIUM N021756 INJECTABLEPEGVISOMANT N021106 INJECTABLEPENICILLIN G BENZATHINE N050141 INJECTABLEPORACTANT ALFA N020744 SUSPENSIONPORFIMER SODIUM N020451 INJECTABLEPREDNISOLONE ACETATE N017100 SUSPENSION/DROPS

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM N012813 SUSPENSION

RIFAPENTINE N021024 TABLETRUBIDIUM CHLORIDE RB-82 N202153 SOLUTIONRUBIDIUM CHLORIDE RB-82 N019414 INJECTABLESALMETEROL XINAFOATE N020692 POWDERSAMARIUM SM-153 LEXIDRONAM PENTASODIUM N020570 INJECTABLESECRETIN SYNTHETIC HUMAN N021256 FOR SOLUTIONSERTACONAZOLE NITRATE N021385 CREAMSILVER SULFADIAZINE N018578 CREAMSOMATROPIN RECOMBINANT N019640 INJECTABLESOMATROPIN RECOMBINANT N019764 INJECTABLESOMATROPIN RECOMBINANT N021426 INJECTABLESOMATROPIN RECOMBINANT N020604 INJECTABLE

14

SOMATROPIN RECOMBINANT N021905 INJECTABLESOMATROPIN RECOMBINANT N019774 INJECTABLESOMATROPIN RECOMBINANT N021597 INJECTABLESOMATROPIN RECOMBINANT N020522 INJECTABLESOMATROPIN RECOMBINANT N020280 INJECTABLESOYBEAN OIL N019942 INJECTABLESUCCIMER N019998 CAPSULESULCONAZOLE NITRATE N018738 SOLUTIONSULCONAZOLE NITRATE N018737 CREAMSUMATRIPTAN SUCCINATE N208223 SOLUTIONTALC N020587 AEROSOL, METEREDTALC N021388 POWDERTECHNETIUM TC-99M ALBUMIN AGGREGATED KIT N017881 INJECTABLETECHNETIUM TC-99M ALBUMIN AGGREGATED KIT N017776 INJECTABLETECHNETIUM TC-99M BICISATE KIT N020256 INJECTABLETECHNETIUM TC-99M DISOFENIN KIT N018467 INJECTABLETECHNETIUM TC-99M EXAMETAZIME KIT N019829 INJECTABLETECHNETIUM TC-99M EXAMETAZIME KIT N208870 POWDERTECHNETIUM TC-99M MEDRONATE N018035 INJECTABLETECHNETIUM TC-99M MERTIATIDE KIT N019882 INJECTABLETECHNETIUM TC-99M OXIDRONATE KIT N018321 INJECTABLETECHNETIUM TC-99M PENTETATE KIT N018511 INJECTABLETECHNETIUM TC-99M RED BLOOD CELL KIT N019981 INJECTABLETECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

N017771 SOLUTION

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

N017693 SOLUTION

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

N017243 SOLUTION

TECHNETIUM TC-99M TETROFOSMIN KIT N020372 INJECTABLETERCONAZOLE N021735 CREAMTESTOSTERONE N202763 GELTHYROTROPIN ALFA N020898 INJECTABLETOBRAMYCIN N050555 OINTMENTTRETINOIN N020400 GELTRIMETHADIONE N005856 TABLETUREA, C-14 N020617 CAPSULEUROFOLLITROPIN N021289 INJECTABLEVALRUBICIN N020892 SOLUTIONVELAGLUCERASE ALFA N022575 INJECTABLEXENON XE-133 N017284 GASXENON XE-133 N018327 GASZANAMIVIR N021036 POWDERZINC ACETATE N020458 CAPSULEZINC CHLORIDE N018959 INJECTABLE

15

Methodology1

1. The list is based on the Orange Book Data Files, accessed October 30, 2017.

2. The list includes Orange Book-listed drug products. The list generally does not differentiate between different strengths of a given drug product. However, we have included a drug product of multiple strengths on the list if there is not an approved ANDA for one or more of the strengths (even if there is an approved ANDA for one or more other strength). The Agency has identified the corresponding NDA numbers for drug products included on the list to assist applicants with identification of the correct reference listed drug (RLD).

3. A given drug product is included on the list if:

a. There is at least one active and approved NDA for the drug product,2,3 and

b. There are no approved ANDAs for the drug product,4 and

c. There are no unexpired patents or exclusivities listed in the Orange Book for the drug product.5

4. Each drug product and corresponding NDA number is then placed on either Part I or Part II of the list based on the following criteria:

a. Part I of the list identifies those drug products for which FDA could immediately accept an ANDA without prior discussion with the Agency.

b. Part II identifies drug products for which development and submission of an ANDA could involve potential legal, regulatory or scientific issues that should be addressed with the Agency prior to considering submission of an ANDA.

1 FDA notes that the methodology used to compile the June 2017 list has been updated for the December 2017 list. Under the updated methodology, the list is organized based on drug products, not active ingredients. This means that an active and approved NDA for a particular active ingredient and dosage form will be included on the list if there are no approved ANDAs for at least one drug product for that active ingredient and dosage form approved in the NDA, even if there are approved ANDAs that reference a drug product in a different NDA with the same active ingredient and dosage form. 2 “Active and approved” means that the NDA for the relevant drug product is approved and listed in the Orange Book, and is not identified as a “discontinued” product in the Orange Book. If all approved NDAs for a given drug product are identified as “discontinued” in the Orange Book, that drug product is not included on the list. 3 Drug products with only approved and Orange Book-listed ANDAs but no Orange Book-listed NDAs are not included on the list. 4 Drug products with an approved but discontinued ANDA are not included on the list. 5 Drug products that have at least one Orange Book-listed patent or exclusivity are not included on the list.

16