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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
December 2013

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on July 15, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
12/02/2013 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065420		 ORIG-1 AMOXICILLIN; CLAVULANATE POTASSIUM CIPLA Approval
12/02/2013 CABERGOLINE
ANDA #202947		 ORIG-1 CABERGOLINE PHARMOBEDIENT Approval
12/03/2013 DESOXYN
NDA #005378		 SUPPL-28 METHAMPHETAMINE HYDROCHLORIDE AJENAT PHARMS Labeling Approval
12/03/2013 NORINYL 1+50 28-DAY
NDA #016659		 SUPPL-136 MESTRANOL; NORETHINDRONE ACTAVIS LABS UT INC Manufacturing (CMC) Approval
12/03/2013 RELPAX
NDA #021016		 SUPPL-26 ELETRIPTAN HYDROBROMIDE UPJOHN Manufacturing (CMC) Approval
12/03/2013 INFUVITE ADULT
NDA #021163		 SUPPL-28 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 SANDOZ CANADA INC Manufacturing (CMC) Approval
12/03/2013 ADDERALL XR 10
NDA #021303		 SUPPL-26 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
12/03/2013 ADDERALL XR 15
NDA #021303		 SUPPL-26 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
12/03/2013 ADDERALL XR 20
NDA #021303		 SUPPL-26 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
12/03/2013 ADDERALL XR 25
NDA #021303		 SUPPL-26 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
12/03/2013 ADDERALL XR 30
NDA #021303		 SUPPL-26 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
12/03/2013 ADDERALL XR 5
NDA #021303		 SUPPL-26 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
12/03/2013 NEOPROFEN
NDA #021903		 SUPPL-8 IBUPROFEN LYSINE RECORDATI RARE Labeling Approval
12/03/2013 TRINTELLIX
NDA #204447		 SUPPL-1 VORTIOXETINE HYDROBROMIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
12/04/2013 AN-SULFUR COLLOID
NDA #017858		 SUPPL-38 TECHNETIUM TC-99M SULFUR COLLOID KIT SUN PHARM INDS INC Manufacturing (CMC) Approval
12/04/2013 STRATTERA
NDA #021411		 SUPPL-45 ATOMOXETINE HYDROCHLORIDE LILLY Labeling Approval
12/04/2013 XANAX XR
NDA #021434		 SUPPL-13 ALPRAZOLAM UPJOHN Manufacturing (CMC) Approval
12/04/2013 ERYTHROCIN STEARATE
ANDA #060359		 SUPPL-28 ERYTHROMYCIN STEARATE AZURITY Labeling Approval
12/04/2013 ERYTHROMYCIN
ANDA #061621		 SUPPL-39 ERYTHROMYCIN CARNEGIE Labeling Approval
12/04/2013 ERYTHROMYCIN ETHYLSUCCINATE
ANDA #061904		 SUPPL-21 ERYTHROMYCIN ETHYLSUCCINATE CARNEGIE Labeling Approval
12/04/2013 ERY-TAB
ANDA #062298		 SUPPL-68 ERYTHROMYCIN CARNEGIE Labeling Approval
12/04/2013 CIPROFLOXACIN EXTENDED RELEASE
ANDA #078712		 SUPPL-1 CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE FOSUN PHARMA Labeling Approval
12/04/2013 DORZOLAMIDE HYDROCHLORIDE
ANDA #091034		 ORIG-1 DORZOLAMIDE HYDROCHLORIDE ZAMBON SPA Approval
12/04/2013 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #091180		 ORIG-1 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE ZAMBON SPA Approval
12/04/2013 FENOFIBRIC ACID
ANDA #200750		 ORIG-1 CHOLINE FENOFIBRATE CHARTWELL RX Approval
12/04/2013 LARIN 1/20
ANDA #202995		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE NOVAST LABS Approval
12/05/2013 ENABLEX
NDA #021513		 SUPPL-9 DARIFENACIN HYDROBROMIDE ABBVIE Manufacturing (CMC) Approval
12/05/2013 ZORTRESS
NDA #021560		 SUPPL-12 EVEROLIMUS NOVARTIS Manufacturing (CMC) Approval
12/05/2013 RESTASIS
NDA #050790		 SUPPL-23 CYCLOSPORINE ABBVIE Manufacturing (CMC) Approval
12/05/2013 RESTASIS MULTIDOSE
NDA #050790		 SUPPL-23 CYCLOSPORINE ABBVIE Manufacturing (CMC) Approval
12/05/2013 YERVOY
BLA #125377		 SUPPL-55 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
12/05/2013 OPANA ER
NDA #201655		 SUPPL-10 OXYMORPHONE HYDROCHLORIDE ENDO PHARMS Labeling Approval
12/05/2013 ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
ANDA #202912		 ORIG-1 ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE LUPIN Approval
12/05/2013 VERSACLOZ
NDA #203479		 SUPPL-1 CLOZAPINE DOUGLAS PHARMS REMS Approval
12/05/2013 OLYSIO
NDA #205123		 SUPPL-1 SIMEPREVIR SODIUM JANSSEN PRODS Labeling Approval
12/06/2013 DEXEDRINE SPANSULE
NDA #017078		 SUPPL-47 DEXTROAMPHETAMINE SULFATE IMPAX LABS INC Labeling Approval
12/06/2013 OPTIRAY 160
NDA #019710		 SUPPL-51 IOVERSOL LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/06/2013 OPTIRAY 240
NDA #019710		 SUPPL-51 IOVERSOL LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/06/2013 OPTIRAY 300
NDA #019710		 SUPPL-51 IOVERSOL LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/06/2013 OPTIRAY 320
NDA #019710		 SUPPL-51 IOVERSOL LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/06/2013 OPTIRAY 350
NDA #019710		 SUPPL-51 IOVERSOL LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/06/2013 COPAXONE
NDA #020622		 SUPPL-91 GLATIRAMER ACETATE TEVA PHARMS USA Manufacturing (CMC) Approval
12/06/2013 INFANT'S ADVIL
NDA #020812		 SUPPL-20 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
12/06/2013 PEDIATRIC ADVIL
NDA #020812		 SUPPL-20 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
12/06/2013 TIKOSYN
NDA #020931		 SUPPL-7 DOFETILIDE PFIZER Labeling Approval
12/06/2013 VYVANSE
NDA #021977		 SUPPL-30 LISDEXAMFETAMINE DIMESYLATE TAKEDA PHARMS USA Labeling Approval
12/06/2013 TYZEKA
NDA #022011		 SUPPL-16 TELBIVUDINE NOVARTIS Manufacturing (CMC) Approval
12/06/2013 TYZEKA
NDA #022154		 SUPPL-13 TELBIVUDINE NOVARTIS Manufacturing (CMC) Approval
12/06/2013 COLY-MYCIN S
NDA #050356		 SUPPL-55 COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE PH HEALTH Manufacturing (CMC) Approval
12/06/2013 DORYX
NDA #050795		 SUPPL-16 DOXYCYCLINE HYCLATE MAYNE PHARMA Manufacturing (CMC) Approval
12/06/2013 DORYX
NDA #050795		 SUPPL-17 DOXYCYCLINE HYCLATE MAYNE PHARMA Manufacturing (CMC) Approval
12/06/2013 DORYX MPC
NDA #050795		 SUPPL-16 DOXYCYCLINE HYCLATE MAYNE PHARMA Manufacturing (CMC) Approval
12/06/2013 DORYX MPC
NDA #050795		 SUPPL-17 DOXYCYCLINE HYCLATE MAYNE PHARMA Manufacturing (CMC) Approval
12/06/2013 XIAFLEX
BLA #125338		 SUPPL-61 COLLAGENASE CLOSTRIDIUM HISTOLYTICUM AUXILIUM PHARMS Approval
12/06/2013 SOVALDI
NDA #204671		 ORIG-1 SOFOSBUVIR GILEAD SCIENCES INC Type 1 - New Molecular Entity Approval
12/07/2013 NASACORT ALLERGY 24 HOUR
NDA #020468		 SUPPL-20 TRIAMCINOLONE ACETONIDE CHATTEM SANOFI Manufacturing (CMC) Approval
12/07/2013 NASACORT ALLERGY 24 HOUR
NDA #020468		 SUPPL-37 TRIAMCINOLONE ACETONIDE CHATTEM SANOFI Manufacturing (CMC) Approval
12/07/2013 PEPCID COMPLETE
NDA #020958		 SUPPL-20 CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE KENVUE BRANDS Manufacturing (CMC) Approval
12/09/2013 HUMULIN N
BLA #018781		 SUPPL-144 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
12/09/2013 HUMULIN 70/30
BLA #019717		 SUPPL-123 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
12/09/2013 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-123 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
12/09/2013 ADENOSCAN
NDA #020059		 SUPPL-15 ADENOSINE ASTELLAS Manufacturing (CMC) Approval
12/09/2013 AEROSPAN HFA
NDA #021247		 SUPPL-10 FLUNISOLIDE PHARMOBEDIENT Manufacturing (CMC) Approval
12/09/2013 CHILDREN'S ALLEGRA ALLERGY
NDA #021909		 SUPPL-9 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
12/09/2013 CHILDREN'S ALLEGRA HIVES
NDA #021909		 SUPPL-9 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
12/09/2013 ZENPEP
BLA #022210		 SUPPL-15 PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) EURAND PHARMA LTD Approval
12/09/2013 ADASUVE
NDA #022549		 SUPPL-2 LOXAPINE NOVA PNEUMA REMS Approval
12/09/2013 PEGINTRON
BLA #103949		 SUPPL-5248 PEGINTERFERON ALFA-2B SCHERING Approval
12/09/2013 SYLATRON
BLA #103949		 SUPPL-5248 PEGINTERFERON ALFA-2B SCHERING Approval
12/09/2013 INDOMETHACIN
ANDA #202572		 ORIG-1 INDOMETHACIN WATSON LABS INC Approval
12/09/2013 ILEVRO
NDA #203491		 SUPPL-5 NEPAFENAC HARROW EYE Manufacturing (CMC) Approval
12/09/2013 AMMONIA N 13
ANDA #203938		 ORIG-1 AMMONIA N-13 KREITCHMAN PET CTR Approval
12/10/2013 ZOFRAN
NDA #020007		 SUPPL-44 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
12/10/2013 ZOFRAN PRESERVATIVE FREE
NDA #020007		 SUPPL-44 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
12/10/2013 ZOFRAN
NDA #020103		 SUPPL-31 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
12/10/2013 ZOFRAN
NDA #020605		 SUPPL-15 ONDANSETRON HYDROCHLORIDE SANDOZ Labeling Approval
12/10/2013 ZOFRAN ODT
NDA #020781		 SUPPL-15 ONDANSETRON SANDOZ Labeling Approval
12/10/2013 XELODA
NDA #020896		 SUPPL-32 CAPECITABINE CHEPLAPHARM Efficacy Approval
12/10/2013 PROTONIX
NDA #020987		 SUPPL-48 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
12/10/2013 SOMAVERT
BLA #021106		 SUPPL-36 PEGVISOMANT PHARMACIA Approval
12/10/2013 PRISTIQ
NDA #021992		 SUPPL-31 DESVENLAFAXINE SUCCINATE PF PRISM CV Labeling Approval
12/10/2013 PROTONIX
NDA #022020		 SUPPL-10 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
12/10/2013 PRADAXA
NDA #022512		 SUPPL-21 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Labeling Approval
12/10/2013 ONDANSETRON HYDROCHLORIDE
ANDA #078257		 SUPPL-3 ONDANSETRON HYDROCHLORIDE ONESOURCE SPECIALTY Labeling Approval
12/10/2013 PANTOPRAZOLE SODIUM
ANDA #078281		 SUPPL-15 PANTOPRAZOLE SODIUM LANNETT CO INC Labeling Approval
12/10/2013 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090865		 SUPPL-6 PRAMIPEXOLE DIHYDROCHLORIDE TORRENT PHARMS Labeling Approval
12/11/2013 HEMABATE
NDA #017989		 SUPPL-19 CARBOPROST TROMETHAMINE PFIZER Labeling Approval
12/11/2013 GONAL-F
BLA #020378		 SUPPL-63 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/11/2013 SEROSTIM
BLA #020604		 SUPPL-75 SOMATROPIN EMD SERONO Approval
12/11/2013 SEROSTIM LQ
BLA #020604		 SUPPL-75 SOMATROPIN EMD SERONO Approval
12/11/2013 OVIDREL
BLA #021149		 SUPPL-36 CHORIOGONADOTROPIN ALFA EMD SERONO Approval
12/11/2013 GONAL-F
BLA #021765		 SUPPL-32 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/11/2013 GONAL-F RFF
BLA #021765		 SUPPL-32 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/11/2013 NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
NDA #022573		 SUPPL-1 ETHINYL ESTRADIOL; NORETHINDRONE TEVA BRANDED PHARM Manufacturing (CMC) Approval
12/11/2013 DULOXETINE HYDROCHLORIDE
ANDA #090694		 ORIG-1 DULOXETINE HYDROCHLORIDE LUPIN Approval
12/11/2013 DULOXETINE HYDROCHLORIDE
ANDA #090723		 ORIG-1 DULOXETINE HYDROCHLORIDE ADAPTIS Approval
12/11/2013 DULOXETINE HYDROCHLORIDE
ANDA #090745		 ORIG-1 DULOXETINE HYDROCHLORIDE SUN PHARM Approval
12/11/2013 DULOXETINE HYDROCHLORIDE
ANDA #090774		 ORIG-1 DULOXETINE HYDROCHLORIDE TORRENT Approval
12/11/2013 DULOXETINE HYDROCHLORIDE
ANDA #090778		 ORIG-1 DULOXETINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
12/11/2013 DULOXETINE HYDROCHLORIDE
ANDA #090783		 ORIG-1 DULOXETINE HYDROCHLORIDE TEVA PHARMS USA Approval
12/12/2013 EFUDEX
NDA #016831		 SUPPL-55 FLUOROURACIL EXTROVIS Manufacturing (CMC) Approval
12/12/2013 HUMULIN N
BLA #018781		 SUPPL-137 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
12/12/2013 HUMULIN 70/30
BLA #019717		 SUPPL-116 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
12/12/2013 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-116 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
12/12/2013 SAIZEN
BLA #019764		 SUPPL-70 SOMATROPIN EMD SERONO Approval
12/12/2013 ZIAC
NDA #020186		 SUPPL-30 BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE TEVA BRANDED PHARM Manufacturing (CMC) Approval
12/12/2013 SEROSTIM
BLA #020604		 SUPPL-76 SOMATROPIN EMD SERONO Approval
12/12/2013 SEROSTIM LQ
BLA #020604		 SUPPL-76 SOMATROPIN EMD SERONO Approval
12/12/2013 PLAVIX
NDA #020839		 SUPPL-58 CLOPIDOGREL BISULFATE SANOFI AVENTIS US Labeling Approval
12/12/2013 PROTONIX IV
NDA #020988		 SUPPL-48 PANTOPRAZOLE SODIUM WYETH PHARMS Labeling Approval
12/12/2013 HUMALOG MIX 75/25
BLA #021017		 SUPPL-95 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
12/12/2013 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-95 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
12/12/2013 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-95 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
12/12/2013 CONCERTA
NDA #021121		 SUPPL-32 METHYLPHENIDATE HYDROCHLORIDE JANSSEN PHARMS Labeling Approval
12/12/2013 FOCALIN
NDA #021278		 SUPPL-17 DEXMETHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
12/12/2013 METHYLIN
NDA #021419		 SUPPL-7 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Labeling Approval
12/12/2013 METHYLIN
NDA #021475		 SUPPL-7 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Labeling Approval
12/12/2013 DAYTRANA
NDA #021514		 SUPPL-17 METHYLPHENIDATE NOVEN PHARMS INC Labeling Approval
12/12/2013 FOCALIN XR
NDA #021802		 SUPPL-26 DEXMETHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
12/12/2013 ULORIC
NDA #021856		 SUPPL-7 FEBUXOSTAT TAKEDA PHARMS USA Manufacturing (CMC) Approval
12/12/2013 VIBATIV
NDA #022110		 SUPPL-8 TELAVANCIN HYDROCHLORIDE CUMBERLAND Manufacturing (CMC) Approval
12/12/2013 DOXIL (LIPOSOMAL)
NDA #050718		 SUPPL-31 DOXORUBICIN HYDROCHLORIDE BAXTER HLTHCARE CORP Manufacturing (CMC) Approval
12/12/2013 CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER
NDA #050780		 SUPPL-18 CEFUROXIME SODIUM B BRAUN Manufacturing (CMC) Approval
12/12/2013 BICALUTAMIDE
ANDA #076932		 SUPPL-4 BICALUTAMIDE TEVA Labeling Approval
12/12/2013 AMYVID
NDA #202008		 SUPPL-20 FLORBETAPIR F-18 AVID RADIOPHARMS INC Labeling Approval
12/12/2013 QUILLIVANT XR
NDA #202100		 SUPPL-3 METHYLPHENIDATE HYDROCHLORIDE NEXTWAVE Labeling Approval
12/12/2013 AMIKACIN SULFATE
ANDA #204040		 ORIG-1 AMIKACIN SULFATE AVET LIFESCIENCES Approval
12/13/2013 RITALIN
NDA #010187		 SUPPL-77 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
12/13/2013 DRYTEC
NDA #017693		 SUPPL-25 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR GE HEALTHCARE Manufacturing (CMC) Approval
12/13/2013 RITALIN-SR
NDA #018029		 SUPPL-47 METHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
12/13/2013 EPI E Z PEN JR
NDA #019430		 SUPPL-57 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
12/13/2013 EPIPEN
NDA #019430		 SUPPL-57 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
12/13/2013 EPIPEN E Z PEN
NDA #019430		 SUPPL-57 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
12/13/2013 EPIPEN JR.
NDA #019430		 SUPPL-57 EPINEPHRINE VIATRIS Manufacturing (CMC) Approval
12/13/2013 ADENOCARD
NDA #019937		 SUPPL-28 ADENOSINE ASTELLAS Manufacturing (CMC) Approval
12/13/2013 TAXOTERE
NDA #020449		 SUPPL-71 DOCETAXEL SANOFI AVENTIS US Labeling Approval
12/13/2013 ANTIZOL
NDA #020696		 SUPPL-5 FOMEPIZOLE PAR PHARM INC Manufacturing (CMC) Approval
12/13/2013 FORADIL
NDA #020831		 SUPPL-33 FORMOTEROL FUMARATE NOVARTIS Manufacturing (CMC) Approval
12/13/2013 AVAGE
NDA #021184		 SUPPL-7 TAZAROTENE ALMIRALL Labeling Approval
12/13/2013 TAZORAC
NDA #021184		 SUPPL-7 TAZAROTENE ALMIRALL Labeling Approval
12/13/2013 METADATE CD
NDA #021259		 SUPPL-27 METHYLPHENIDATE HYDROCHLORIDE LANNETT Labeling Approval
12/13/2013 RITALIN LA
NDA #021284		 SUPPL-23 METHYLPHENIDATE HYDROCHLORIDE SANDOZ Labeling Approval
12/13/2013 PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 PRISMASOL BGK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 PRISMASOL BGK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 PRISMASOL BK 0/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-12 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE VANTIVE US HLTHCARE Manufacturing (CMC) Approval
12/13/2013 MEN'S ROGAINE
NDA #021812		 SUPPL-10 MINOXIDIL KENVUE BRANDS Labeling Approval
12/13/2013 WOMEN'S ROGAINE
NDA #021812		 SUPPL-10 MINOXIDIL KENVUE BRANDS Labeling Approval
12/13/2013 BRILINTA
NDA #022433		 SUPPL-10 TICAGRELOR ASTRAZENECA Labeling Approval
12/13/2013 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076980		 SUPPL-9 HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE TEVA Labeling Approval
12/13/2013 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #076980		 SUPPL-11 HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE TEVA Manufacturing (CMC) Approval
12/13/2013 LEVALBUTEROL HYDROCHLORIDE
ANDA #078171		 ORIG-1 LEVALBUTEROL HYDROCHLORIDE CIPLA Approval
12/13/2013 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #090096		 SUPPL-2 HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE CHARTWELL RX Labeling Approval
12/13/2013 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #090718		 SUPPL-3 HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE GLENMARK PHARMS Labeling Approval
12/13/2013 MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #090718		 SUPPL-6 HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE GLENMARK PHARMS Labeling Approval
12/13/2013 FELODIPINE
ANDA #091200		 ORIG-1 FELODIPINE SUN PHARM INDS LTD Approval
12/13/2013 BENLYSTA
BLA #125370		 SUPPL-47 BELIMUMAB HUMAN GENOME SCIENCES INC. Approval
12/13/2013 COMPLERA
NDA #202123		 SUPPL-12 EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Efficacy Approval
12/13/2013 KALYDECO
NDA #203188		 SUPPL-3 IVACAFTOR VERTEX PHARMS Manufacturing (CMC) Approval
12/14/2013 ONDANSETRON HYDROCHLORIDE
ANDA #077577		 SUPPL-1 ONDANSETRON HYDROCHLORIDE WOCKHARDT BIO AG Labeling Approval
12/14/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077716		 SUPPL-3 ONDANSETRON HYDROCHLORIDE WOCKHARDT BIO AG Labeling Approval
12/15/2013 TYSABRI
BLA #125104		 SUPPL-840 NATALIZUMAB BIOGEN IDEC Approval
12/15/2013 TYSABRI
BLA #125104		 SUPPL-847 NATALIZUMAB BIOGEN IDEC Approval
12/15/2013 TYSABRI
BLA #125104		 SUPPL-889 NATALIZUMAB BIOGEN IDEC Approval
12/16/2013 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #018826		 SUPPL-44 DOPAMINE HYDROCHLORIDE HOSPIRA Manufacturing (CMC) Approval
12/16/2013 PENTASA
NDA #020049		 SUPPL-26 MESALAMINE TAKEDA PHARMS USA Labeling Approval
12/16/2013 LOTEMAX
NDA #020583		 SUPPL-28 LOTEPREDNOL ETABONATE BAUSCH AND LOMB Manufacturing (CMC) Approval
12/16/2013 ALREX
NDA #020803		 SUPPL-26 LOTEPREDNOL ETABONATE BAUSCH AND LOMB Manufacturing (CMC) Approval
12/16/2013 TRUVADA
NDA #021752		 SUPPL-43 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD Labeling Approval
12/16/2013 LIALDA
NDA #022000		 SUPPL-11 MESALAMINE TAKEDA PHARMS USA Labeling Approval
12/16/2013 GIAZO
NDA #022205		 SUPPL-1 BALSALAZIDE DISODIUM VALEANT PHARMS INTL Labeling Approval
12/16/2013 MERREM IV
NDA #050706		 SUPPL-32 MEROPENEM PFIZER Labeling Approval
12/16/2013 MERREM IV
NDA #050706		 SUPPL-34 MEROPENEM PFIZER Labeling Approval
12/16/2013 SERTRALINE HYDROCHLORIDE
ANDA #077670		 SUPPL-16 SERTRALINE HYDROCHLORIDE LUPIN Labeling Approval
12/16/2013 SERTRALINE HYDROCHLORIDE
ANDA #077670		 SUPPL-20 SERTRALINE HYDROCHLORIDE LUPIN Labeling Approval
12/16/2013 AVASTIN
BLA #125085		 SUPPL-285 BEVACIZUMAB GENENTECH Approval
12/16/2013 TEFLARO
NDA #200327		 SUPPL-11 CEFTAROLINE FOSAMIL ABBVIE Labeling Approval
12/17/2013 ADAGEN
BLA #019818		 SUPPL-51 PEGADEMASE BOVINE LEADIANT BIOSCI INC Approval
12/17/2013 GEODON
NDA #020825		 SUPPL-49 ZIPRASIDONE HYDROCHLORIDE VIATRIS Labeling Approval
12/17/2013 GEODON
NDA #020919		 SUPPL-35 ZIPRASIDONE MESYLATE VIATRIS Labeling Approval
12/17/2013 CANASA
NDA #021252		 SUPPL-20 MESALAMINE ABBVIE Labeling Approval
12/17/2013 MOVIPREP
NDA #021881		 SUPPL-16 ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE SALIX PHARMS Labeling Approval
12/17/2013 VIIBRYD
NDA #022567		 SUPPL-9 VILAZODONE HYDROCHLORIDE ABBVIE Labeling Approval
12/17/2013 DULOXETINE HYDROCHLORIDE
ANDA #090776		 ORIG-1 DULOXETINE HYDROCHLORIDE ACTAVIS ELIZABETH Approval
12/17/2013 SILDENAFIL CITRATE
ANDA #203814		 ORIG-1 SILDENAFIL CITRATE MACLEODS PHARMS LTD Approval
12/17/2013 JUXTAPID
NDA #203858		 SUPPL-4 LOMITAPIDE MESYLATE CHIESI Manufacturing (CMC) Approval
12/18/2013 STIMATE
NDA #020355		 SUPPL-19 DESMOPRESSIN ACETATE FERRING PHARMS INC Manufacturing (CMC) Approval
12/18/2013 STIMATE (NEEDS NO REFRIGERATION)
NDA #020355		 SUPPL-19 DESMOPRESSIN ACETATE FERRING PHARMS INC Manufacturing (CMC) Approval
12/18/2013 CANCIDAS
NDA #021227		 SUPPL-32 CASPOFUNGIN ACETATE MERCK Manufacturing (CMC) Approval
12/18/2013 CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER
NDA #065430		 SUPPL-6 CEFOTETAN DISODIUM B BRAUN Manufacturing (CMC) Approval
12/18/2013 PEGINTRON
BLA #103949		 SUPPL-5259 PEGINTERFERON ALFA-2B SCHERING Approval
12/18/2013 SYLATRON
BLA #103949		 SUPPL-5259 PEGINTERFERON ALFA-2B SCHERING Approval
12/18/2013 GADAVIST
NDA #201277		 SUPPL-4 GADOBUTROL BAYER HLTHCARE Manufacturing (CMC) Approval
12/18/2013 JENTADUETO
NDA #201281		 SUPPL-5 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
12/18/2013 ANORO ELLIPTA
NDA #203975		 ORIG-1 UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE GLAXOSMITHKLINE Type 1 - New Molecular Entity and Type 4 - New Combination Approval
12/18/2013 ADRENALIN
NDA #204640		 ORIG-1 EPINEPHRINE PH HEALTH Type 7 - Drug Already Marketed without Approved NDA Approval
12/19/2013 PROPYLTHIOURACIL
NDA #006188		 SUPPL-23 PROPYLTHIOURACIL PH HEALTH Manufacturing (CMC) Approval
12/19/2013 DARANIDE
NDA #011366		 SUPPL-29 DICHLORPHENAMIDE XERIS Manufacturing (CMC) Approval
12/19/2013 KEVEYIS
NDA #011366		 SUPPL-29 DICHLORPHENAMIDE XERIS Manufacturing (CMC) Approval
12/19/2013 TENUATE DOSPAN
NDA #012546		 SUPPL-33 DIETHYLPROPION HYDROCHLORIDE ANI PHARMS Manufacturing (CMC) Approval
12/19/2013 CONRAY
NDA #013295		 SUPPL-64 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/19/2013 CONRAY 43
NDA #013295		 SUPPL-64 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/19/2013 CONRAY 30
NDA #016983		 SUPPL-32 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/19/2013 CYSTO-CONRAY
NDA #017057		 SUPPL-31 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/19/2013 CYSTO-CONRAY II
NDA #017057		 SUPPL-31 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/19/2013 HALDOL
NDA #018701		 SUPPL-69 HALOPERIDOL DECANOATE JANSSEN PHARMS Manufacturing (CMC) Approval
12/19/2013 OPTIRAY 160
NDA #019710		 SUPPL-50 IOVERSOL LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/19/2013 OPTIRAY 240
NDA #019710		 SUPPL-50 IOVERSOL LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/19/2013 OPTIRAY 300
NDA #019710		 SUPPL-50 IOVERSOL LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/19/2013 OPTIRAY 320
NDA #019710		 SUPPL-50 IOVERSOL LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/19/2013 OPTIRAY 350
NDA #019710		 SUPPL-50 IOVERSOL LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/19/2013 RETROVIR
NDA #019951		 SUPPL-31 ZIDOVUDINE VIIV HLTHCARE Manufacturing (CMC) Approval
12/19/2013 GONAL-F
BLA #020378		 SUPPL-64 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/19/2013 OPTIRAY 240
NDA #020923		 SUPPL-16 IOVERSOL LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/19/2013 OPTIRAY 300
NDA #020923		 SUPPL-16 IOVERSOL LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/19/2013 OPTIRAY 320
NDA #020923		 SUPPL-16 IOVERSOL LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/19/2013 OPTIRAY 350
NDA #020923		 SUPPL-16 IOVERSOL LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
12/19/2013 OVIDREL
BLA #021149		 SUPPL-37 CHORIOGONADOTROPIN ALFA EMD SERONO Approval
12/19/2013 CAVERJECT IMPULSE
NDA #021212		 SUPPL-7 ALPROSTADIL PFIZER Labeling Approval
12/19/2013 RANEXA
NDA #021526		 SUPPL-26 RANOLAZINE MENARINI INTL Labeling Approval
12/19/2013 GONAL-F
BLA #021765		 SUPPL-34 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/19/2013 GONAL-F RFF
BLA #021765		 SUPPL-34 FOLLITROPIN ALFA/BETA EMD SERONO Approval
12/19/2013 BARACLUDE
NDA #021797		 SUPPL-17 ENTECAVIR BRISTOL MYERS SQUIBB Labeling Approval
12/19/2013 BARACLUDE
NDA #021798		 SUPPL-18 ENTECAVIR BRISTOL MYERS SQUIBB Labeling Approval
12/19/2013 REVLIMID
NDA #021880		 SUPPL-36 LENALIDOMIDE BRISTOL MYERS SQUIBB Manufacturing (CMC) Approval
12/19/2013 KUVAN
NDA #022181		 SUPPL-9 SAPROPTERIN DIHYDROCHLORIDE BIOMARIN PHARM Efficacy Approval
12/19/2013 KUVAN
NDA #022181		 SUPPL-10 SAPROPTERIN DIHYDROCHLORIDE BIOMARIN PHARM Efficacy Approval
12/19/2013 ERYC
NDA #050536		 SUPPL-23 ERYTHROMYCIN DR REDDYS LABS SA Manufacturing (CMC) Approval
12/19/2013 ERYC
NDA #050536		 SUPPL-24 ERYTHROMYCIN DR REDDYS LABS SA Manufacturing (CMC) Approval
12/19/2013 OMEPRAZOLE
ANDA #076515		 SUPPL-16 OMEPRAZOLE SANDOZ Labeling Approval
12/19/2013 OMEPRAZOLE
ANDA #076515		 SUPPL-18 OMEPRAZOLE SANDOZ Labeling Approval
12/19/2013 ONDANSETRON HYDROCHLORIDE
ANDA #077050		 SUPPL-5 ONDANSETRON HYDROCHLORIDE SUN PHARM INDS (IN) Labeling Approval
12/19/2013 VENLAFAXINE HYDROCHLORIDE
ANDA #200834		 SUPPL-5 VENLAFAXINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/19/2013 VENLAFAXINE HYDROCHLORIDE
ANDA #200834		 SUPPL-6 VENLAFAXINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/19/2013 VENLAFAXINE HYDROCHLORIDE
ANDA #200834		 SUPPL-7 VENLAFAXINE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
12/19/2013 ESCITALOPRAM OXALATE
ANDA #202227		 SUPPL-1 ESCITALOPRAM OXALATE AMNEAL PHARMS Labeling Approval
12/19/2013 ERIVEDGE
NDA #203388		 SUPPL-3 VISMODEGIB GENENTECH Manufacturing (CMC) Approval
12/19/2013 BRISDELLE
NDA #204516		 SUPPL-1 PAROXETINE MESYLATE LEGACY Manufacturing (CMC) Approval
12/19/2013 KUVAN
NDA #205065		 ORIG-1 SAPROPTERIN DIHYDROCHLORIDE BIOMARIN PHARM Type 3 - New Dosage Form Approval
12/20/2013 ULTRA-TECHNEKOW V4
NDA #017243		 SUPPL-44 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR CURIUM Labeling Approval
12/20/2013 TYLENOL
NDA #019872		 SUPPL-39 ACETAMINOPHEN KENVUE BRANDS Labeling Approval
12/20/2013 METASTRON
NDA #020134		 SUPPL-12 STRONTIUM CHLORIDE SR-89 Q BIOMED Labeling Approval
12/20/2013 LAMICTAL
NDA #020241		 SUPPL-39 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
12/20/2013 CHILDREN'S ADVIL
NDA #020589		 SUPPL-29 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
12/20/2013 CHILDREN'S ADVIL-FLAVORED
NDA #020589		 SUPPL-29 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
12/20/2013 LAMICTAL CD
NDA #020764		 SUPPL-32 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
12/20/2013 EPIVIR-HBV
NDA #021003		 SUPPL-15 LAMIVUDINE GLAXOSMITHKLINE Labeling Approval
12/20/2013 EPIVIR-HBV
NDA #021004		 SUPPL-15 LAMIVUDINE GLAXOSMITHKLINE Labeling Approval
12/20/2013 TAMIFLU
NDA #021087		 SUPPL-63 OSELTAMIVIR PHOSPHATE ROCHE Manufacturing (CMC) Approval
12/20/2013 XYREM
NDA #021196		 SUPPL-18 SODIUM OXYBATE JAZZ PHARMS Manufacturing (CMC) Approval
12/20/2013 ZEGERID
NDA #021636		 SUPPL-14 OMEPRAZOLE; SODIUM BICARBONATE SALIX Manufacturing (CMC) Approval
12/20/2013 RELISTOR
NDA #021964		 SUPPL-14 METHYLNALTREXONE BROMIDE SALIX PHARMS Manufacturing (CMC) Approval
12/20/2013 TORISEL
NDA #022088		 SUPPL-15 TEMSIROLIMUS PF PRISM CV Manufacturing (CMC) Approval
12/20/2013 LAMICTAL XR
NDA #022115		 SUPPL-3 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
12/20/2013 ISENTRESS
NDA #022145		 SUPPL-31 RALTEGRAVIR POTASSIUM MSD SUB MERCK Efficacy Approval
12/20/2013 ISENTRESS HD
NDA #022145		 SUPPL-31 RALTEGRAVIR POTASSIUM MSD SUB MERCK Efficacy Approval
12/20/2013 LAMICTAL ODT
NDA #022251		 SUPPL-1 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
12/20/2013 DESLORATADINE
ANDA #078357		 SUPPL-1 DESLORATADINE ORBION PHARMS Labeling Approval
12/20/2013 ORENCIA
BLA #125118		 SUPPL-171 ABATACEPT BRISTOL MYERS SQUIBB Approval
12/20/2013 AMPICILLIN SODIUM
ANDA #201404		 ORIG-1 AMPICILLIN SODIUM ISTITUTO BIO ITA SPA Approval
12/20/2013 ISENTRESS
NDA #203045		 SUPPL-9 RALTEGRAVIR POTASSIUM MSD SUB MERCK Efficacy Approval
12/20/2013 ICLUSIG
NDA #203469		 SUPPL-7 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Labeling Approval
12/20/2013 ICLUSIG
NDA #203469		 SUPPL-8 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA REMS Approval
12/20/2013 ORENITRAM
NDA #203496		 ORIG-1 TREPROSTINIL DIOLAMINE UNITED THERAP Type 3 - New Dosage Form Approval
12/20/2013 METOCLOPRAMIDE
ANDA #204756		 ORIG-1 METOCLOPRAMIDE HYDROCHLORIDE AVET LIFESCIENCES Approval
12/20/2013 ISENTRESS
NDA #205786		 ORIG-1 RALTEGRAVIR POTASSIUM MSD SUB MERCK Type 3 - New Dosage Form Approval
12/23/2013 SURMONTIL
NDA #016792		 SUPPL-35 TRIMIPRAMINE MALEATE TEVA WOMENS Manufacturing (CMC) Approval
12/23/2013 WELLBUTRIN
NDA #018644		 SUPPL-46 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
12/23/2013 WELLBUTRIN
NDA #018644		 SUPPL-47 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
12/23/2013 WELLBUTRIN SR
NDA #020358		 SUPPL-53 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
12/23/2013 WELLBUTRIN SR
NDA #020358		 SUPPL-54 BUPROPION HYDROCHLORIDE GLAXOSMITHKLINE Labeling Approval
12/23/2013 INFASURF PRESERVATIVE FREE
BLA #020521		 SUPPL-25 CALFACTANT ONY Approval
12/23/2013 FOSAMAX
NDA #020560		 SUPPL-66 ALENDRONATE SODIUM ORGANON Labeling Approval
12/23/2013 LYRICA
NDA #021446		 SUPPL-29 PREGABALIN UPJOHN Labeling Approval
12/23/2013 FOSAMAX
NDA #021575		 SUPPL-23 ALENDRONATE SODIUM MERCK Labeling Approval
12/23/2013 PRISTIQ
NDA #021992		 SUPPL-37 DESVENLAFAXINE SUCCINATE PF PRISM CV Labeling Approval
12/23/2013 FERAHEME
NDA #022180		 SUPPL-10 FERUMOXYTOL AZURITY Manufacturing (CMC) Approval
12/23/2013 LYRICA
NDA #022488		 SUPPL-8 PREGABALIN UPJOHN Manufacturing (CMC) Approval
12/23/2013 ABELCET
NDA #050724		 SUPPL-17 AMPHOTERICIN B LEADIANT BIOSCI INC Manufacturing (CMC) Approval
12/23/2013 DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
ANDA #078271		 ORIG-1 DESMOPRESSIN ACETATE SUN PHARM Approval
12/23/2013 BINOSTO
NDA #202344		 SUPPL-6 ALENDRONATE SODIUM RADIUS Manufacturing (CMC) Approval
12/23/2013 SODIUM FLUORIDE F-18
ANDA #203247		 ORIG-1 SODIUM FLUORIDE F-18 UNIV TX MD ANDERSON Approval
12/23/2013 LAMOTRIGINE
ANDA #203370		 ORIG-1 LAMOTRIGINE TORRENT Approval
12/23/2013 FLUDEOXYGLUCOSE F18
ANDA #203709		 ORIG-1 FLUDEOXYGLUCOSE F-18 WISCONSIN Approval
12/24/2013 HECTOROL
NDA #021027		 SUPPL-28 DOXERCALCIFEROL SANOFI Manufacturing (CMC) Approval
12/24/2013 CANASA
NDA #021252		 SUPPL-18 MESALAMINE ABBVIE Manufacturing (CMC) Approval
12/24/2013 ONDANSETRON HYDROCHLORIDE
ANDA #077473		 SUPPL-7 ONDANSETRON HYDROCHLORIDE HOSPIRA Labeling Approval
12/24/2013 ONDANSETRON HYDROCHLORIDE
ANDA #077473		 SUPPL-8 ONDANSETRON HYDROCHLORIDE HOSPIRA Labeling Approval
12/24/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077548		 SUPPL-7 ONDANSETRON HYDROCHLORIDE HOSPIRA Labeling Approval
12/24/2013 ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077548		 SUPPL-8 ONDANSETRON HYDROCHLORIDE HOSPIRA Labeling Approval
12/26/2013 XYLOCAINE
NDA #006488		 SUPPL-88 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
12/26/2013 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-88 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Manufacturing (CMC) Approval
12/26/2013 DILANTIN
ANDA #084349		 SUPPL-71 PHENYTOIN SODIUM VIATRIS Labeling Approval
12/26/2013 DILANTIN
ANDA #084427		 SUPPL-29 PHENYTOIN PHARMACIA Labeling Approval
12/26/2013 OXYCODONE AND ACETAMINOPHEN
ANDA #090535		 ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE SUN PHARM INDS INC Approval
12/26/2013 TAFINLAR
NDA #202806		 SUPPL-1 DABRAFENIB MESYLATE NOVARTIS Labeling Approval
12/26/2013 POTASSIUM CHLORIDE
ANDA #202886		 ORIG-1 POTASSIUM CHLORIDE PH HEALTH Approval
12/27/2013 DUAC
NDA #050741		 SUPPL-21 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE STIEFEL Labeling Approval
12/27/2013 PAROXETINE HYDROCHLORIDE
ANDA #077873		 SUPPL-20 PAROXETINE HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
12/27/2013 PAROXETINE HYDROCHLORIDE
ANDA #091427		 SUPPL-5 PAROXETINE HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
12/27/2013 SIMPONI
BLA #125289		 SUPPL-103 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
12/30/2013 SINGULAIR
NDA #020829		 SUPPL-66 MONTELUKAST SODIUM ORGANON Labeling Approval
12/30/2013 SINGULAIR
NDA #020830		 SUPPL-68 MONTELUKAST SODIUM ORGANON Labeling Approval
12/30/2013 SINGULAIR
NDA #021409		 SUPPL-43 MONTELUKAST SODIUM ORGANON Labeling Approval
12/30/2013 KEFLEX
NDA #050405		 SUPPL-104 CEPHALEXIN PRAGMA Manufacturing (CMC) Approval
12/30/2013 ONDANSETRON HYDROCHLORIDE
ANDA #077729		 SUPPL-1 ONDANSETRON HYDROCHLORIDE TARO Labeling Approval
12/30/2013 DIVALPROEX SODIUM
ANDA #090407		 SUPPL-2 DIVALPROEX SODIUM RISING Labeling Approval
12/30/2013 DIVALPROEX SODIUM
ANDA #090407		 SUPPL-5 DIVALPROEX SODIUM RISING Labeling Approval
12/30/2013 AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #091431		 ORIG-1 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE HERITAGE Approval
12/30/2013 EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
NDA #204568		 ORIG-1 EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE CIPLA Type 4 - New Combination Tentative Approval
12/31/2013 PRALIDOXIME CHLORIDE (AUTOINJECTOR)
NDA #018986		 SUPPL-43 PRALIDOXIME CHLORIDE MERIDIAN MEDCL TECHN Manufacturing (CMC) Approval
12/31/2013 NITROGLYCERIN IN DEXTROSE 5%
NDA #019970		 SUPPL-14 NITROGLYCERIN BAXTER HLTHCARE Manufacturing (CMC) Approval
12/31/2013 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040444		 SUPPL-12 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE EPIC PHARMA LLC Labeling Approval
12/31/2013 EXTENDED PHENYTOIN SODIUM
ANDA #040765		 SUPPL-4 PHENYTOIN SODIUM AMNEAL PHARMS NY Labeling Approval
12/31/2013 PAROXETINE HYDROCHLORIDE
ANDA #075356		 SUPPL-35 PAROXETINE HYDROCHLORIDE APOTEX Labeling Approval
12/31/2013 OMEPRAZOLE
ANDA #075757		 SUPPL-33 OMEPRAZOLE SANDOZ Labeling Approval
12/31/2013 OMEPRAZOLE
ANDA #075757		 SUPPL-36 OMEPRAZOLE SANDOZ Labeling Approval
12/31/2013 FOSINOPRIL SODIUM
ANDA #076483		 SUPPL-7 FOSINOPRIL SODIUM CHARTWELL RX Labeling Approval
12/31/2013 FOSINOPRIL SODIUM
ANDA #076483		 SUPPL-13 FOSINOPRIL SODIUM CHARTWELL RX Labeling Approval
12/31/2013 PAROXETINE HYDROCHLORIDE
ANDA #076618		 SUPPL-19 PAROXETINE HYDROCHLORIDE CHARTWELL RX Labeling Approval
12/31/2013 FOSINOPRIL SODIUM
ANDA #076906		 SUPPL-10 FOSINOPRIL SODIUM APOTEX Labeling Approval
12/31/2013 FINASTERIDE
ANDA #077251		 SUPPL-2 FINASTERIDE GEDEON RICHTER USA Labeling Approval
12/31/2013 PAROXETINE HYDROCHLORIDE
ANDA #078406		 SUPPL-21 PAROXETINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
12/31/2013 PAROXETINE HYDROCHLORIDE
ANDA #078902		 SUPPL-14 PAROXETINE HYDROCHLORIDE MYLAN Labeling Approval
12/31/2013 FOSINOPRIL SODIUM
ANDA #091163		 SUPPL-4 FOSINOPRIL SODIUM AUROBINDO PHARMA LTD Labeling Approval
12/31/2013 TROSPIUM CHLORIDE
ANDA #091575		 SUPPL-8 TROSPIUM CHLORIDE GLENMARK PHARMS LTD Labeling Approval
12/31/2013 METHYLPHENIDATE HYDROCHLORIDE
ANDA #091695		 SUPPL-2 METHYLPHENIDATE HYDROCHLORIDE LANNETT CO INC Labeling Approval
12/31/2013 EPOGEN/PROCRIT
BLA #103234		 SUPPL-5323 EPOETIN ALFA AMGEN Approval
12/31/2013 ARANESP
BLA #103951		 SUPPL-5325 DARBEPOETIN ALFA AMGEN Approval
12/31/2013 ARANESP
BLA #103951		 SUPPL-5349 DARBEPOETIN ALFA AMGEN Approval
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