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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
February 2015

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 September 17, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
02/02/2015 MIACALCIN
NDA #017808		 SUPPL-36 CALCITONIN SALMON MYLAN IRELAND LTD Labeling Approval
02/02/2015 CIPRO
NDA #019537		 SUPPL-83 CIPROFLOXACIN HYDROCHLORIDE BAYER HLTHCARE Efficacy Approval
02/02/2015 ZOCOR
NDA #019766		 SUPPL-93 SIMVASTATIN ORGANON Labeling Approval
02/02/2015 CIPRO
NDA #019847		 SUPPL-55 CIPROFLOXACIN BAYER HLTHCARE Efficacy Approval
02/02/2015 CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019857		 SUPPL-63 CIPROFLOXACIN BAYER HLTHCARE Efficacy Approval
02/02/2015 CIPRO
NDA #020780		 SUPPL-41 CIPROFLOXACIN BAYER HLTHCARE Efficacy Approval
02/02/2015 VYTORIN
NDA #021687		 SUPPL-53 EZETIMIBE; SIMVASTATIN ORGANON Labeling Approval
02/02/2015 FLUCONAZOLE
ANDA #076957		 SUPPL-4 FLUCONAZOLE THINQ PHARM-CRO PVT Labeling Approval
02/02/2015 OLOPATADINE HYDROCHLORIDE
ANDA #203416		 ORIG-1 OLOPATADINE HYDROCHLORIDE WATSON LABS Tentative Approval
02/03/2015 M.V.I.-12 ADULT
NDA #008809		 SUPPL-67 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Manufacturing (CMC) Approval
02/03/2015 M.V.I.-12 ADULT
NDA #008809		 SUPPL-67 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Manufacturing (CMC) Approval
02/03/2015 COGENTIN
NDA #012015		 SUPPL-32 BENZTROPINE MESYLATE EPIC PHARMA LLC Manufacturing (CMC) Approval
02/03/2015 CONRAY
NDA #013295		 SUPPL-67 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
02/03/2015 CONRAY 43
NDA #013295		 SUPPL-67 IOTHALAMATE MEGLUMINE LIEBEL-FLARSHEIM Manufacturing (CMC) Approval
02/03/2015 LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016679		 SUPPL-110 CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 TRANXENE
NDA #017105		 SUPPL-78 CLORAZEPATE DIPOTASSIUM AJENAT PHARMS Manufacturing (CMC) Approval
02/03/2015 TRANXENE SD
NDA #017105		 SUPPL-78 CLORAZEPATE DIPOTASSIUM AJENAT PHARMS Manufacturing (CMC) Approval
02/03/2015 PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
NDA #017378		 SUPPL-69 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 PLASMA-LYTE A IN PLASTIC CONTAINER
NDA #017378		 SUPPL-69 MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER
NDA #017484		 SUPPL-70 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 DEXTROSE 20% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-70 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 DEXTROSE 30% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-70 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 DEXTROSE 40% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-70 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 DEXTROSE 50% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-70 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 DEXTROSE 60% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-70 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 DEXTROSE 70% IN PLASTIC CONTAINER
NDA #017521		 SUPPL-70 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 KLONOPIN
NDA #017533		 SUPPL-54 CLONAZEPAM CHEPLAPHARM Manufacturing (CMC) Approval
02/03/2015 MICRO-K
NDA #018238		 SUPPL-44 POTASSIUM CHLORIDE NESHER PHARMS Manufacturing (CMC) Approval
02/03/2015 MICRO-K 10
NDA #018238		 SUPPL-44 POTASSIUM CHLORIDE NESHER PHARMS Manufacturing (CMC) Approval
02/03/2015 TIS-U-SOL
NDA #018508		 SUPPL-21 MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 TRAVASOL 10% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-48 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 TRAVASOL 5.5% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-48 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 TRAVASOL 8.5% IN PLASTIC CONTAINER
NDA #018931		 SUPPL-48 AMINO ACIDS BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 PREPIDIL
NDA #019617		 SUPPL-18 DINOPROSTONE PFIZER Manufacturing (CMC) Approval
02/03/2015 POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
NDA #019904		 SUPPL-15 POTASSIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
NDA #019904		 SUPPL-15 POTASSIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
NDA #019904		 SUPPL-15 POTASSIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
NDA #019904		 SUPPL-15 POTASSIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 DEXTROSE 50% IN PLASTIC CONTAINER
NDA #020047		 SUPPL-22 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 DEXTROSE 60% IN PLASTIC CONTAINER
NDA #020047		 SUPPL-22 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 DEXTROSE 70% IN PLASTIC CONTAINER
NDA #020047		 SUPPL-22 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/03/2015 NICODERM CQ
NDA #020165		 SUPPL-34 NICOTINE CHATTEM SANOFI Labeling Approval
02/03/2015 NEUROLITE
NDA #020256		 SUPPL-15 TECHNETIUM TC-99M BICISATE KIT LANTHEUS MEDCL Manufacturing (CMC) Approval
02/03/2015 PROVENTIL-HFA
NDA #020503		 SUPPL-49 ALBUTEROL SULFATE KINDEVA Manufacturing (CMC) Approval
02/03/2015 TRELSTAR
NDA #020715		 SUPPL-34 TRIPTORELIN PAMOATE VERITY Manufacturing (CMC) Approval
02/03/2015 ALDARA
NDA #020723		 SUPPL-26 IMIQUIMOD BAUSCH Manufacturing (CMC) Approval
02/03/2015 EXELON
NDA #020823		 SUPPL-32 RIVASTIGMINE TARTRATE NOVARTIS Labeling Approval
02/03/2015 VIAGRA
NDA #020895		 SUPPL-40 SILDENAFIL CITRATE VIATRIS Manufacturing (CMC) Approval
02/03/2015 VIRAMUNE
NDA #020933		 SUPPL-37 NEVIRAPINE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
02/03/2015 EXELON
NDA #021025		 SUPPL-22 RIVASTIGMINE TARTRATE NOVARTIS Labeling Approval
02/03/2015 IMODIUM MULTI-SYMPTOM RELIEF
NDA #021140		 SUPPL-21 LOPERAMIDE HYDROCHLORIDE; SIMETHICONE J AND J CONSUMER INC Manufacturing (CMC) Approval
02/03/2015 LOPROX
NDA #021159		 SUPPL-21 CICLOPIROX BAUSCH Manufacturing (CMC) Approval
02/03/2015 ATNAA
NDA #021175		 SUPPL-26 ATROPINE; PRALIDOXIME CHLORIDE US ARMY Manufacturing (CMC) Approval
02/03/2015 VFEND
NDA #021266		 SUPPL-38 VORICONAZOLE PF PRISM CV Labeling Approval
02/03/2015 VFEND
NDA #021267		 SUPPL-47 VORICONAZOLE PF PRISM CV Labeling Approval
02/03/2015 HICON
NDA #021305		 SUPPL-38 SODIUM IODIDE I-131 JUBILANT Manufacturing (CMC) Approval
02/03/2015 SODIUM IODIDE I 131
NDA #021305		 SUPPL-38 SODIUM IODIDE I-131 JUBILANT Manufacturing (CMC) Approval
02/03/2015 FINACEA
NDA #021470		 SUPPL-9 AZELAIC ACID LEO PHARMA AS Manufacturing (CMC) Approval
02/03/2015 ZOVIRAX
NDA #021478		 SUPPL-8 ACYCLOVIR BAUSCH Manufacturing (CMC) Approval
02/03/2015 VFEND
NDA #021630		 SUPPL-28 VORICONAZOLE PF PRISM CV Labeling Approval
02/03/2015 REVATIO
NDA #021845		 SUPPL-9 SILDENAFIL CITRATE VIATRIS Manufacturing (CMC) Approval
02/03/2015 ABILIFY
NDA #021866		 SUPPL-24 ARIPIPRAZOLE OTSUKA Manufacturing (CMC) Approval
02/03/2015 PREZISTA
NDA #021976		 SUPPL-37 DARUNAVIR JANSSEN PRODS Manufacturing (CMC) Approval
02/03/2015 EXELON
NDA #022083		 SUPPL-20 RIVASTIGMINE SANDOZ Labeling Approval
02/03/2015 DOCEFREZ
NDA #022534		 SUPPL-5 DOCETAXEL SUN PHARM Manufacturing (CMC) Approval
02/03/2015 DOCETAXEL
NDA #022534		 SUPPL-5 DOCETAXEL SUN PHARM Manufacturing (CMC) Approval
02/03/2015 VPRIV
BLA #022575		 SUPPL-16 VELAGLUCERASE ALFA SHIRE HUMAN GENETIC Approval
02/03/2015 ELITEK
BLA #103946		 SUPPL-5094 RASBURICASE SANOFI SYNTHELABO Approval
02/03/2015 NITHIODOTE
NDA #201444		 SUPPL-16 SODIUM NITRITE; SODIUM THIOSULFATE HOPE PHARMS Manufacturing (CMC) Approval
02/03/2015 LEVETIRACETAM IN SODIUM CHLORIDE
NDA #202543		 SUPPL-5 LEVETIRACETAM HQ SPCLT PHARMA Manufacturing (CMC) Approval
02/03/2015 QNASL
NDA #202813		 SUPPL-8 BECLOMETHASONE DIPROPIONATE TEVA BRANDED PHARM Manufacturing (CMC) Approval
02/03/2015 PICATO
NDA #202833		 SUPPL-3 INGENOL MEBUTATE LEO LABS Manufacturing (CMC) Approval
02/03/2015 TESTOSTERONE
NDA #203098		 SUPPL-4 TESTOSTERONE PERRIGO ISRAEL Manufacturing (CMC) Approval
02/03/2015 VIZAMYL
NDA #203137		 SUPPL-1 FLUTEMETAMOL F-18 GE HEALTHCARE Manufacturing (CMC) Approval
02/03/2015 ICLUSIG
NDA #203469		 SUPPL-14 PONATINIB HYDROCHLORIDE TAKEDA PHARMS USA Manufacturing (CMC) Approval
02/03/2015 DESVENLAFAXINE
NDA #205583		 SUPPL-4 DESVENLAFAXINE FUMARATE SUN PHARM Manufacturing (CMC) Approval
02/03/2015 IBRANCE
NDA #207103		 ORIG-1 PALBOCICLIB PFIZER Type 1 - New Molecular Entity Approval
02/04/2015 CELESTONE SOLUSPAN
NDA #014602		 SUPPL-59 BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE ORGANON Labeling Approval
02/04/2015 ALEVE
NDA #020204		 SUPPL-46 NAPROXEN SODIUM BAYER Manufacturing (CMC) Approval
02/04/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040444		 SUPPL-14 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE EPIC PHARMA LLC Labeling Approval
02/04/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040444		 SUPPL-16 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE EPIC PHARMA LLC Labeling Approval
02/04/2015 FLUOXETINE HYDROCHLORIDE
ANDA #076022		 SUPPL-3 FLUOXETINE HYDROCHLORIDE CARLSBAD Labeling Approval
02/04/2015 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #077302		 SUPPL-14 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE ACTAVIS ELIZABETH Labeling Approval
02/04/2015 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #077628		 SUPPL-7 IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
02/04/2015 HYDROMORPHONE HYDROCHLORIDE
ANDA #078228		 SUPPL-2 HYDROMORPHONE HYDROCHLORIDE RISING Labeling Approval
02/04/2015 HYDROMORPHONE HYDROCHLORIDE
ANDA #078261		 SUPPL-2 HYDROMORPHONE HYDROCHLORIDE RISING Labeling Approval
02/04/2015 BUPRENORPHINE HYDROCHLORIDE
ANDA #078633		 SUPPL-7 BUPRENORPHINE HYDROCHLORIDE HIKMA Labeling Approval
02/04/2015 OXCARBAZEPINE
ANDA #078734		 SUPPL-3 OXCARBAZEPINE SUN PHARM INDS LTD Labeling Approval
02/04/2015 OXCARBAZEPINE
ANDA #078734		 SUPPL-7 OXCARBAZEPINE SUN PHARM INDS LTD Labeling Approval
02/04/2015 OXCARBAZEPINE
ANDA #078734		 SUPPL-8 OXCARBAZEPINE SUN PHARM INDS LTD Labeling Approval
02/04/2015 ZIPRASIDONE HYDROCHLORIDE
ANDA #090348		 SUPPL-1 ZIPRASIDONE HYDROCHLORIDE CHARTWELL RX Labeling Approval
02/04/2015 BUPRENORPHINE HYDROCHLORIDE
ANDA #090360		 SUPPL-2 BUPRENORPHINE HYDROCHLORIDE BARR Labeling Approval
02/04/2015 BUPRENORPHINE HYDROCHLORIDE
ANDA #090360		 SUPPL-8 BUPRENORPHINE HYDROCHLORIDE BARR Labeling Approval
02/04/2015 BUPRENORPHINE HYDROCHLORIDE
ANDA #090622		 SUPPL-6 BUPRENORPHINE HYDROCHLORIDE ETHYPHARM Labeling Approval
02/04/2015 BUPRENORPHINE HYDROCHLORIDE
ANDA #090622		 SUPPL-13 BUPRENORPHINE HYDROCHLORIDE ETHYPHARM Labeling Approval
02/04/2015 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091422		 SUPPL-11 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
02/04/2015 OXCARBAZEPINE
ANDA #202961		 SUPPL-1 OXCARBAZEPINE AMNEAL PHARMS Labeling Approval
02/04/2015 OXCARBAZEPINE
ANDA #202961		 SUPPL-2 OXCARBAZEPINE AMNEAL PHARMS Labeling Approval
02/04/2015 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203326		 SUPPL-3 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE HIKMA Labeling Approval
02/04/2015 FLUDEOXYGLUCOSE F18
ANDA #203994		 ORIG-1 FLUDEOXYGLUCOSE F-18 NORTHLAND Approval
02/04/2015 AMMONIA N 13
ANDA #204515		 ORIG-1 AMMONIA N-13 NCM USA BRONX LLC Approval
02/05/2015 ACCURETIC
NDA #020125		 SUPPL-19 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE PFIZER PHARMS Labeling Approval
02/05/2015 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091149		 SUPPL-2 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
02/05/2015 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203136		 SUPPL-7 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
02/06/2015 ATACAND
NDA #020838		 SUPPL-36 CANDESARTAN CILEXETIL ANI PHARMS Labeling Approval
02/06/2015 FLUOCINONIDE
ANDA #071535		 SUPPL-17 FLUOCINONIDE COSETTE Manufacturing (CMC) Approval
02/06/2015 EPITOL
ANDA #073524		 SUPPL-42 CARBAMAZEPINE TEVA Labeling Approval
02/06/2015 EPITOL
ANDA #073524		 SUPPL-43 CARBAMAZEPINE TEVA Labeling Approval
02/06/2015 ISOFLURANE
ANDA #074416		 SUPPL-7 ISOFLURANE PIRAMAL CRITICAL Labeling Approval
02/06/2015 METOPROLOL TARTRATE
ANDA #076704		 SUPPL-20 METOPROLOL TARTRATE MYLAN Labeling Approval
02/06/2015 RIBAVIRIN
ANDA #077456		 SUPPL-17 RIBAVIRIN CHARTWELL RX Labeling Approval
02/06/2015 CARBIDOPA AND LEVODOPA
ANDA #078536		 SUPPL-12 CARBIDOPA; LEVODOPA SUN PHARM INDS Labeling Approval
02/06/2015 DEXAMETHASONE
ANDA #088254		 SUPPL-15 DEXAMETHASONE PHARMOBEDIENT CNSLTG Labeling Approval
02/06/2015 LAMOTRIGINE
ANDA #090169		 SUPPL-1 LAMOTRIGINE GLENMARK PHARMS LTD Labeling Approval
02/06/2015 NEUPOGEN
BLA #103353		 SUPPL-5184 FILGRASTIM AMGEN Approval
02/06/2015 LUCENTIS
BLA #125156		 SUPPL-106 RANIBIZUMAB GENENTECH Approval
02/06/2015 CIPROFLOXACIN
ANDA #200563		 SUPPL-1 CIPROFLOXACIN CHARTWELL Manufacturing (CMC) Approval
02/06/2015 MORPHINE SULFATE
ANDA #200812		 SUPPL-3 MORPHINE SULFATE STRIDES PHARMA Labeling Approval
02/06/2015 TENOFOVIR DISOPROXIL FUMARATE
ANDA #204402		 ORIG-1 TENOFOVIR DISOPROXIL FUMARATE LUPIN LTD Tentative Approval
02/06/2015 DUTREBIS
NDA #206510		 ORIG-1 LAMIVUDINE; RALTEGRAVIR POTASSIUM MERCK SHARP DOHME Type 4 - New Combination Approval
02/09/2015 DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-118 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 TECHNELITE
NDA #017771		 SUPPL-36 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR LANTHEUS MEDCL Manufacturing (CMC) Approval
02/09/2015 BSS PLUS
NDA #018469		 SUPPL-53 CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE ALCON Manufacturing (CMC) Approval
02/09/2015 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-25 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-25 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-25 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-24 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-24 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-24 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-24 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
02/09/2015 GONAL-F
BLA #020378		 SUPPL-68 FOLLITROPIN ALFA/BETA EMD SERONO Approval
02/09/2015 DENAVIR
NDA #020629		 SUPPL-17 PENCICLOVIR MYLAN Manufacturing (CMC) Approval
02/09/2015 CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-30 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/09/2015 CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-30 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/09/2015 CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-30 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/09/2015 CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-30 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/09/2015 CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-30 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/09/2015 CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-30 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/09/2015 CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-30 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/09/2015 CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-30 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/09/2015 CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-30 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/09/2015 CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-30 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/09/2015 CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-30 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/09/2015 CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-30 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
02/09/2015 TARGRETIN
NDA #021056		 SUPPL-6 BEXAROTENE BAUSCH Manufacturing (CMC) Approval
02/09/2015 ATACAND HCT
NDA #021093		 SUPPL-16 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE ANI PHARMS Labeling Approval
02/09/2015 RAZADYNE
NDA #021169		 SUPPL-30 GALANTAMINE HYDROBROMIDE JANSSEN PHARMS Labeling Approval
02/09/2015 RAZADYNE
NDA #021224		 SUPPL-28 GALANTAMINE HYDROBROMIDE JANSSEN PHARMS Labeling Approval
02/09/2015 AEROSPAN HFA
NDA #021247		 SUPPL-12 FLUNISOLIDE MYLAN SPECIALITY LP Manufacturing (CMC) Approval
02/09/2015 LEVO-T
NDA #021342		 SUPPL-24 LEVOTHYROXINE SODIUM CEDIPROF INC Manufacturing (CMC) Approval
02/09/2015 RAZADYNE ER
NDA #021615		 SUPPL-21 GALANTAMINE HYDROBROMIDE JANSSEN PHARMS Labeling Approval
02/09/2015 NUVIGIL
NDA #021875		 SUPPL-20 ARMODAFINIL CEPHALON Manufacturing (CMC) Approval
02/09/2015 RELISTOR
NDA #021964		 SUPPL-15 METHYLNALTREXONE BROMIDE SALIX PHARMS Manufacturing (CMC) Approval
02/09/2015 FLUORESCITE
NDA #021980		 SUPPL-6 FLUORESCEIN SODIUM ALCON LABS INC Manufacturing (CMC) Approval
02/09/2015 EGRIFTA
BLA #022505		 SUPPL-6 TESAMORELIN ACETATE THERATECHNOLOGIES Approval
02/09/2015 UNASYN
NDA #050608		 SUPPL-43 AMPICILLIN SODIUM; SULBACTAM SODIUM PFIZER Manufacturing (CMC) Approval
02/09/2015 CAYSTON
NDA #050814		 SUPPL-10 AZTREONAM GILEAD Manufacturing (CMC) Approval
02/09/2015 LETROZOLE
ANDA #090838		 SUPPL-4 LETROZOLE HIKMA Labeling Approval
02/09/2015 KOMBIGLYZE XR
NDA #200678		 SUPPL-14 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE ASTRAZENECA AB Manufacturing (CMC) Approval
02/09/2015 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #201090		 SUPPL-2 AMOXICILLIN; CLAVULANATE POTASSIUM AUROBINDO PHARMA LTD Labeling Approval
02/09/2015 STENDRA
NDA #202276		 SUPPL-9 AVANAFIL METUCHEN PHARMS Manufacturing (CMC) Approval
02/09/2015 MYRBETRIQ
NDA #202611		 SUPPL-4 MIRABEGRON APGDI Manufacturing (CMC) Approval
02/10/2015 PROPYLTHIOURACIL
NDA #006188		 SUPPL-24 PROPYLTHIOURACIL ENDO OPERATIONS Labeling Approval
02/10/2015 MEN'S ROGAINE
NDA #021812		 SUPPL-11 MINOXIDIL JOHNSON AND JOHNSON Labeling Approval
02/10/2015 WOMEN'S ROGAINE
NDA #021812		 SUPPL-11 MINOXIDIL JOHNSON AND JOHNSON Labeling Approval
02/10/2015 RIZATRIPTAN BENZOATE
ANDA #078173		 SUPPL-2 RIZATRIPTAN BENZOATE NORVIUM BIOSCIENCE Manufacturing (CMC) Approval
02/10/2015 BROMFENAC SODIUM
ANDA #201941		 ORIG-1 BROMFENAC SODIUM CHARTWELL RX Approval
02/11/2015 ALAWAY
NDA #021996		 SUPPL-5 KETOTIFEN FUMARATE BAUSCH AND LOMB Manufacturing (CMC) Approval
02/11/2015 ALAWAY
NDA #021996		 SUPPL-8 KETOTIFEN FUMARATE BAUSCH AND LOMB Labeling Approval
02/11/2015 CHILDREN'S ALAWAY
NDA #021996		 SUPPL-5 KETOTIFEN FUMARATE BAUSCH AND LOMB Manufacturing (CMC) Approval
02/11/2015 CHILDREN'S ALAWAY
NDA #021996		 SUPPL-8 KETOTIFEN FUMARATE BAUSCH AND LOMB Labeling Approval
02/11/2015 GABLOFEN
NDA #022462		 SUPPL-8 BACLOFEN PIRAMAL CRITICAL Labeling Approval
02/11/2015 DESLORATADINE
ANDA #078357		 SUPPL-4 DESLORATADINE ORBION PHARMS Labeling Approval
02/11/2015 DESLORATADINE
ANDA #078367		 SUPPL-2 DESLORATADINE REDDYS Labeling Approval
02/11/2015 CELECOXIB
ANDA #078857		 ORIG-2 CELECOXIB NORVIUM BIOSCIENCE Approval
02/11/2015 LEVOFLOXACIN
ANDA #091678		 SUPPL-3 LEVOFLOXACIN NOVITIUM PHARMA Manufacturing (CMC) Approval
02/11/2015 CELECOXIB
ANDA #200562		 ORIG-1 CELECOXIB WATSON LABS INC Approval
02/11/2015 XELJANZ
NDA #203214		 SUPPL-8 TOFACITINIB CITRATE PF PRISM CV REMS Approval
02/12/2015 ZOLADEX
NDA #019726		 SUPPL-59 GOSERELIN ACETATE TERSERA Labeling Approval
02/12/2015 ZOLADEX
NDA #020578		 SUPPL-37 GOSERELIN ACETATE TERSERA Labeling Approval
02/12/2015 BANZEL
NDA #021911		 SUPPL-12 RUFINAMIDE EISAI INC Labeling Approval
02/12/2015 AZITHROMYCIN
ANDA #065153		 SUPPL-16 AZITHROMYCIN TEVA Labeling Approval
02/12/2015 AZITHROMYCIN
ANDA #065193		 SUPPL-16 AZITHROMYCIN TEVA Labeling Approval
02/12/2015 AMPICILLIN AND SULBACTAM
ANDA #065310		 SUPPL-13 AMPICILLIN SODIUM; SULBACTAM SODIUM SANDOZ Labeling Approval
02/12/2015 AMPICILLIN AND SULBACTAM
ANDA #065310		 SUPPL-15 AMPICILLIN SODIUM; SULBACTAM SODIUM SANDOZ Labeling Approval
02/12/2015 AZITHROMYCIN
ANDA #065404		 SUPPL-5 AZITHROMYCIN CHARTWELL RX Labeling Approval
02/12/2015 AZITHROMYCIN
ANDA #065405		 SUPPL-5 AZITHROMYCIN CHARTWELL RX Labeling Approval
02/12/2015 AZITHROMYCIN
ANDA #065511		 SUPPL-3 AZITHROMYCIN HOSPIRA Labeling Approval
02/12/2015 AZITHROMYCIN
ANDA #065511		 SUPPL-4 AZITHROMYCIN HOSPIRA Labeling Approval
02/12/2015 BUPRENORPHINE HYDROCHLORIDE
ANDA #078633		 SUPPL-6 BUPRENORPHINE HYDROCHLORIDE HIKMA REMS Approval
02/12/2015 BUPRENORPHINE HYDROCHLORIDE
ANDA #090360		 SUPPL-7 BUPRENORPHINE HYDROCHLORIDE BARR REMS Approval
02/12/2015 BUPRENORPHINE HYDROCHLORIDE
ANDA #090622		 SUPPL-12 BUPRENORPHINE HYDROCHLORIDE ETHYPHARM REMS Approval
02/12/2015 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091149		 SUPPL-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE TEVA PHARMS USA REMS Approval
02/12/2015 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #091422		 SUPPL-12 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ACTAVIS ELIZABETH REMS Approval
02/12/2015 BANZEL
NDA #201367		 SUPPL-3 RUFINAMIDE EISAI INC Efficacy Approval
02/12/2015 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203136		 SUPPL-6 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE AMNEAL PHARMS REMS Approval
02/12/2015 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #203326		 SUPPL-2 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE HIKMA REMS Approval
02/12/2015 ZUBSOLV
NDA #204242		 SUPPL-5 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE OREXO US INC REMS Approval
02/12/2015 BUNAVAIL
NDA #205637		 SUPPL-4 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE BDSI REMS Approval
02/13/2015 TRENTAL
NDA #018631		 SUPPL-40 PENTOXIFYLLINE VALIDUS PHARMS Labeling Approval
02/13/2015 PROMETHAZINE HYDROCHLORIDE
ANDA #040785		 SUPPL-1 PROMETHAZINE HYDROCHLORIDE WOCKHARDT Labeling Approval
02/13/2015 CLARITHROMYCIN
ANDA #065178		 SUPPL-11 CLARITHROMYCIN HIKMA Labeling Approval
02/13/2015 CLARITHROMYCIN
ANDA #065178		 SUPPL-12 CLARITHROMYCIN HIKMA Labeling Approval
02/13/2015 CLARITHROMYCIN
ANDA #065178		 SUPPL-13 CLARITHROMYCIN HIKMA Labeling Approval
02/13/2015 ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #075788		 SUPPL-9 ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TARO PHARM INDS Manufacturing (CMC) Approval
02/13/2015 BROMOCRIPTINE MESYLATE
ANDA #076962		 SUPPL-7 BROMOCRIPTINE MESYLATE AUROBINDO PHARMA USA Labeling Approval
02/13/2015 LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077157		 SUPPL-9 HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM TEVA PHARMS Labeling Approval
02/13/2015 BROMOCRIPTINE MESYLATE
ANDA #077226		 SUPPL-8 BROMOCRIPTINE MESYLATE MYLAN Labeling Approval
02/13/2015 DESLORATADINE
ANDA #078364		 SUPPL-9 DESLORATADINE CHARTWELL RX Labeling Approval
02/13/2015 HYDROCORTISONE
ANDA #083365		 SUPPL-42 HYDROCORTISONE HIKMA INTL PHARMS Labeling Approval
02/13/2015 DONEPEZIL HYDROCHLORIDE
ANDA #090100		 SUPPL-1 DONEPEZIL HYDROCHLORIDE ZYDUS LIFESCIENCES Labeling Approval
02/13/2015 LETROZOLE
ANDA #090289		 SUPPL-2 LETROZOLE TEVA PHARMS Labeling Approval
02/13/2015 LETROZOLE
ANDA #090289		 SUPPL-3 LETROZOLE TEVA PHARMS Labeling Approval
02/13/2015 LETROZOLE
ANDA #090934		 SUPPL-5 LETROZOLE ACCORD HLTHCARE Labeling Approval
02/13/2015 LETROZOLE
ANDA #090934		 SUPPL-6 LETROZOLE ACCORD HLTHCARE Labeling Approval
02/13/2015 ESZOPICLONE
ANDA #091151		 SUPPL-2 ESZOPICLONE MYLAN PHARMS INC Labeling Approval
02/13/2015 LOSARTAN POTASSIUM
ANDA #091497		 SUPPL-5 LOSARTAN POTASSIUM PRINSTON INC Labeling Approval
02/13/2015 ACTIVASE
BLA #103172		 SUPPL-5203 ALTEPLASE GENENTECH Approval
02/13/2015 CATHFLO ACTIVASE
BLA #103172		 SUPPL-5203 ALTEPLASE GENENTECH Approval
02/13/2015 LOSARTAN POTASSIUM
ANDA #200290		 SUPPL-2 LOSARTAN POTASSIUM IPCA LABS LTD Labeling Approval
02/13/2015 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #203027		 ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE APOTEX Approval
02/13/2015 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203630		 SUPPL-4 HYDROCHLOROTHIAZIDE; IRBESARTAN AUROBINDO PHARMA LTD Labeling Approval
02/13/2015 LENVIMA
NDA #206947		 ORIG-1 LENVATINIB MESYLATE EISAI INC Type 1 - New Molecular Entity Approval
02/16/2015 ULTRA-TECHNEKOW FM
NDA #017243		 SUPPL-45 TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR CURIUM Manufacturing (CMC) Approval
02/16/2015 SAIZEN
BLA #019764		 SUPPL-76 SOMATROPIN EMD SERONO Approval
02/16/2015 DILAUDID
NDA #019891		 SUPPL-19 HYDROMORPHONE HYDROCHLORIDE RHODES PHARMS Manufacturing (CMC) Approval
02/16/2015 GENOTROPIN
BLA #020280		 SUPPL-80 SOMATROPIN PHARMACIA Approval
02/16/2015 GENOTROPIN PRESERVATIVE FREE
BLA #020280		 SUPPL-80 SOMATROPIN PHARMACIA Approval
02/16/2015 DIOVAN
NDA #020665		 SUPPL-36 VALSARTAN NOVARTIS Manufacturing (CMC) Approval
02/16/2015 SUCRAID
BLA #020772		 SUPPL-19 SACROSIDASE QOL MEDCL Approval
02/16/2015 MICARDIS
NDA #020850		 SUPPL-37 TELMISARTAN BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
02/16/2015 LUNESTA
NDA #021476		 SUPPL-27 ESZOPICLONE WAYLIS THERAP Manufacturing (CMC) Approval
02/16/2015 CUBICIN
NDA #021572		 SUPPL-47 DAPTOMYCIN CUBIST PHARMS LLC Manufacturing (CMC) Approval
02/16/2015 CUBICIN RF
NDA #021572		 SUPPL-47 DAPTOMYCIN CUBIST PHARMS LLC Manufacturing (CMC) Approval
02/16/2015 VITRASE
BLA #021640		 SUPPL-24 HYALURONIDASE BAUSCH AND LOMB Approval
02/16/2015 PENTETATE CALCIUM TRISODIUM
NDA #021749		 SUPPL-9 PENTETATE CALCIUM TRISODIUM HAMELN Manufacturing (CMC) Approval
02/16/2015 XARELTO
NDA #022406		 SUPPL-13 RIVAROXABAN JANSSEN PHARMS Manufacturing (CMC) Approval
02/16/2015 BETHKIS
NDA #201820		 SUPPL-1 TOBRAMYCIN CHIESI Manufacturing (CMC) Approval
02/16/2015 XARELTO
NDA #202439		 SUPPL-13 RIVAROXABAN JANSSEN PHARMS Manufacturing (CMC) Approval
02/16/2015 IMMPHENTIV
NDA #203826		 SUPPL-5 PHENYLEPHRINE HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
02/16/2015 PHENYLEPHRINE HYDROCHLORIDE
NDA #203826		 SUPPL-5 PHENYLEPHRINE HYDROCHLORIDE HIKMA Manufacturing (CMC) Approval
02/16/2015 XOFIGO
NDA #203971		 SUPPL-1 RADIUM RA-223 DICHLORIDE BAYER HLTHCARE Manufacturing (CMC) Approval
02/16/2015 AKYNZEO
NDA #205718		 SUPPL-1 NETUPITANT; PALONOSETRON HYDROCHLORIDE HELSINN HLTHCARE Manufacturing (CMC) Approval
02/17/2015 CADUET
NDA #021540		 SUPPL-37 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM PHARMACIA Labeling Approval
02/17/2015 REVLIMID
NDA #021880		 SUPPL-41 LENALIDOMIDE BRISTOL MYERS SQUIBB Efficacy Approval
02/17/2015 AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065162		 SUPPL-8 AMOXICILLIN; CLAVULANATE POTASSIUM TEVA Labeling Approval
02/17/2015 FLECAINIDE ACETATE
ANDA #076278		 SUPPL-5 FLECAINIDE ACETATE HIKMA Manufacturing (CMC) Approval
02/17/2015 DIVALPROEX SODIUM
ANDA #077100		 SUPPL-14 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
02/17/2015 DIVALPROEX SODIUM
ANDA #077100		 SUPPL-16 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
02/17/2015 DEPO-TESTOSTERONE
ANDA #085635		 SUPPL-26 TESTOSTERONE CYPIONATE PFIZER Labeling Approval
02/17/2015 LETROZOLE
ANDA #091303		 SUPPL-1 LETROZOLE APOTEX INC Labeling Approval
02/17/2015 LETROZOLE
ANDA #091466		 SUPPL-2 LETROZOLE SUN PHARM INDS LTD Labeling Approval
02/17/2015 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201505		 SUPPL-2 HYDROCHLOROTHIAZIDE; IRBESARTAN APOTEX INC Labeling Approval
02/17/2015 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #201505		 SUPPL-4 HYDROCHLOROTHIAZIDE; IRBESARTAN APOTEX INC Labeling Approval
02/17/2015 IRBESARTAN HYDROCHLOROTHIAZIDE
ANDA #201505		 SUPPL-2 HYDROCHLOROTHIAZIDE; IRBESARTAN APOTEX INC Labeling Approval
02/17/2015 IRBESARTAN HYDROCHLOROTHIAZIDE
ANDA #201505		 SUPPL-4 HYDROCHLOROTHIAZIDE; IRBESARTAN APOTEX INC Labeling Approval
02/18/2015 DEXTROSE 10% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-30 DEXTROSE B BRAUN Manufacturing (CMC) Approval
02/18/2015 DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-30 DEXTROSE B BRAUN Manufacturing (CMC) Approval
02/18/2015 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-30 DEXTROSE B BRAUN Manufacturing (CMC) Approval
02/18/2015 DEXTROSE 7.7% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-30 DEXTROSE B BRAUN Manufacturing (CMC) Approval
02/18/2015 DEXTROSE 70% IN PLASTIC CONTAINER
NDA #019626		 SUPPL-30 DEXTROSE B BRAUN Manufacturing (CMC) Approval
02/18/2015 CUTIVATE
NDA #019957		 SUPPL-12 FLUTICASONE PROPIONATE FOUGERA PHARMS Labeling Approval
02/18/2015 ISENTRESS
NDA #022145		 SUPPL-34 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
02/18/2015 ISENTRESS HD
NDA #022145		 SUPPL-34 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
02/18/2015 GLYBURIDE (MICRONIZED)
ANDA #074591		 SUPPL-7 GLYBURIDE STRIDES PHARMA Labeling Approval
02/18/2015 BROMOCRIPTINE MESYLATE
ANDA #074631		 SUPPL-9 BROMOCRIPTINE MESYLATE SANDOZ Labeling Approval
02/18/2015 GLYBURIDE (MICRONIZED)
ANDA #074792		 SUPPL-13 GLYBURIDE NATCO PHARMA Labeling Approval
02/18/2015 CARBAMAZEPINE
ANDA #075948		 SUPPL-8 CARBAMAZEPINE APOTEX INC Labeling Approval
02/18/2015 CARBAMAZEPINE
ANDA #075948		 SUPPL-9 CARBAMAZEPINE APOTEX INC Labeling Approval
02/18/2015 CARBAMAZEPINE
ANDA #075948		 SUPPL-10 CARBAMAZEPINE APOTEX INC Labeling Approval
02/18/2015 CARBAMAZEPINE
ANDA #075948		 SUPPL-11 CARBAMAZEPINE APOTEX INC Labeling Approval
02/18/2015 HYDROMORPHONE HYDROCHLORIDE
ANDA #076444		 SUPPL-3 HYDROMORPHONE HYDROCHLORIDE BARR Labeling Approval
02/18/2015 MOMETASONE FUROATE
ANDA #076481		 SUPPL-7 MOMETASONE FUROATE ENCUBE Labeling Approval
02/18/2015 CARBAMAZEPINE
ANDA #076697		 SUPPL-4 CARBAMAZEPINE NOSTRUM LABS INC Labeling Approval
02/18/2015 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077446		 SUPPL-6 HYDROCHLOROTHIAZIDE; IRBESARTAN SANDOZ Labeling Approval
02/18/2015 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077446		 SUPPL-7 HYDROCHLOROTHIAZIDE; IRBESARTAN SANDOZ Labeling Approval
02/18/2015 DONEPEZIL HYDROCHLORIDE
ANDA #077518		 SUPPL-1 DONEPEZIL HYDROCHLORIDE CIPLA LTD Labeling Approval
02/18/2015 GLYBURIDE AND METFORMIN HYDROCHLORIDE
ANDA #077870		 SUPPL-6 GLYBURIDE; METFORMIN HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
02/18/2015 GLYBURIDE AND METFORMIN HYDROCHLORIDE
ANDA #077870		 SUPPL-13 GLYBURIDE; METFORMIN HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
02/18/2015 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #077969		 SUPPL-4 HYDROCHLOROTHIAZIDE; IRBESARTAN NORVIUM BIOSCIENCE Labeling Approval
02/18/2015 OXYCODONE HYDROCHLORIDE AND IBUPROFEN
ANDA #078316		 SUPPL-2 IBUPROFEN; OXYCODONE HYDROCHLORIDE BARR LABS INC Labeling Approval
02/18/2015 HYDROMORPHONE HYDROCHLORIDE
ANDA #078591		 SUPPL-1 HYDROMORPHONE HYDROCHLORIDE HOSPIRA INC Labeling Approval
02/18/2015 HYDROMORPHONE HYDROCHLORIDE
ANDA #078591		 SUPPL-2 HYDROMORPHONE HYDROCHLORIDE HOSPIRA INC Labeling Approval
02/18/2015 LAMOTRIGINE
ANDA #078625		 SUPPL-4 LAMOTRIGINE RUBICON Labeling Approval
02/18/2015 LAMOTRIGINE
ANDA #078625		 SUPPL-5 LAMOTRIGINE RUBICON Labeling Approval
02/18/2015 LAMOTRIGINE
ANDA #078625		 SUPPL-6 LAMOTRIGINE RUBICON Labeling Approval
02/18/2015 LAMOTRIGINE
ANDA #078645		 SUPPL-7 LAMOTRIGINE SANDOZ Labeling Approval
02/18/2015 GLYBURIDE AND METFORMIN HYDROCHLORIDE
ANDA #079009		 SUPPL-3 GLYBURIDE; METFORMIN HYDROCHLORIDE HERITAGE Labeling Approval
02/18/2015 LEVETIRACETAM
ANDA #079120		 SUPPL-5 LEVETIRACETAM BIONPHARMA Labeling Approval
02/18/2015 LEVETIRACETAM
ANDA #079120		 SUPPL-6 LEVETIRACETAM BIONPHARMA Labeling Approval
02/18/2015 LEVETIRACETAM
ANDA #079120		 SUPPL-7 LEVETIRACETAM BIONPHARMA Labeling Approval
02/18/2015 LEVETIRACETAM
ANDA #079120		 SUPPL-8 LEVETIRACETAM BIONPHARMA Labeling Approval
02/18/2015 LEVETIRACETAM
ANDA #079120		 SUPPL-11 LEVETIRACETAM BIONPHARMA Labeling Approval
02/18/2015 DONEPEZIL HYDROCHLORIDE
ANDA #090175		 SUPPL-2 DONEPEZIL HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
02/18/2015 GLYBURIDE
ANDA #090937		 SUPPL-4 GLYBURIDE HERITAGE Labeling Approval
02/18/2015 RAMIPRIL
ANDA #091604		 SUPPL-3 RAMIPRIL AUROBINDO PHARMA LTD Labeling Approval
02/18/2015 RAMIPRIL
ANDA #091604		 SUPPL-4 RAMIPRIL AUROBINDO PHARMA LTD Labeling Approval
02/18/2015 RAMIPRIL
ANDA #091604		 SUPPL-5 RAMIPRIL AUROBINDO PHARMA LTD Labeling Approval
02/18/2015 RAMIPRIL
ANDA #091604		 SUPPL-6 RAMIPRIL AUROBINDO PHARMA LTD Labeling Approval
02/18/2015 GABAPENTIN
ANDA #200651		 SUPPL-6 GABAPENTIN AUROBINDO PHARMA LTD Labeling Approval
02/18/2015 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202414		 SUPPL-8 HYDROCHLOROTHIAZIDE; IRBESARTAN MACLEODS PHARMS LTD Labeling Approval
02/18/2015 IRBESARTAN; HYDROCHLOROTHIAZIDE
ANDA #202414		 SUPPL-8 IRBESARTAN: HYDROCHLOROTHIAZIDE MACLEODS PHARMS LTD Labeling Approval
02/18/2015 LARIN 24 FE
ANDA #202994		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE NOVAST LABS Approval
02/18/2015 ISENTRESS
NDA #203045		 SUPPL-11 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
02/18/2015 ISENTRESS
NDA #205786		 SUPPL-2 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
02/19/2015 EPIVIR
NDA #020564		 SUPPL-34 LAMIVUDINE VIIV HLTHCARE Labeling Approval
02/19/2015 EPIVIR
NDA #020596		 SUPPL-33 LAMIVUDINE VIIV HLTHCARE Labeling Approval
02/19/2015 ZIAGEN
NDA #020977		 SUPPL-28 ABACAVIR SULFATE VIIV HLTHCARE Labeling Approval
02/19/2015 ZIAGEN
NDA #020978		 SUPPL-32 ABACAVIR SULFATE VIIV HLTHCARE Labeling Approval
02/19/2015 EPZICOM
NDA #021652		 SUPPL-18 ABACAVIR SULFATE; LAMIVUDINE VIIV HLTHCARE Labeling Approval
02/19/2015 BUPRENORPHINE HYDROCHLORIDE
ANDA #090819		 ORIG-1 BUPRENORPHINE HYDROCHLORIDE ACTAVIS ELIZABETH Approval
02/19/2015 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #091116		 ORIG-1 CETIRIZINE HYDROCHLORIDE JUBILANT GENERICS Approval
02/19/2015 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
ANDA #091116		 ORIG-1 CETIRIZINE HYDROCHLORIDE JUBILANT GENERICS Approval
02/19/2015 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202770		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE XIROMED Approval
02/20/2015 TRISENOX
NDA #021248		 SUPPL-13 ARSENIC TRIOXIDE CEPHALON Labeling Approval
02/20/2015 ISENTRESS
NDA #022145		 SUPPL-35 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
02/20/2015 ISENTRESS HD
NDA #022145		 SUPPL-35 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
02/20/2015 ASTEPRO
NDA #022203		 SUPPL-10 AZELASTINE HYDROCHLORIDE MYLAN SPECIALITY LP Efficacy Approval
02/20/2015 ASTEPRO
NDA #022203		 SUPPL-11 AZELASTINE HYDROCHLORIDE MYLAN SPECIALITY LP Efficacy Approval
02/20/2015 ESMOLOL HYDROCHLORIDE
ANDA #201126		 ORIG-1 ESMOLOL HYDROCHLORIDE AM REGENT Approval
02/20/2015 DYMISTA
NDA #202236		 SUPPL-8 AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE MYLAN SPECIALITY LP Efficacy Approval
02/20/2015 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202741		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE XIROMED Approval
02/20/2015 OLANZAPINE
ANDA #203044		 ORIG-1 OLANZAPINE MACLEODS PHARMS LTD Approval
02/20/2015 ISENTRESS
NDA #203045		 SUPPL-12 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
02/20/2015 BIMATOPROST
ANDA #203991		 ORIG-1 BIMATOPROST LUPIN LTD Approval
02/20/2015 ISENTRESS
NDA #205786		 SUPPL-3 RALTEGRAVIR POTASSIUM MSD SUB MERCK Labeling Approval
02/21/2015 SANDOSTATIN
NDA #019667		 SUPPL-62 OCTREOTIDE ACETATE NOVARTIS Labeling Approval
02/23/2015 SOMA
NDA #011792		 SUPPL-46 CARISOPRODOL MYLAN SPECIALITY LP Labeling Approval
02/23/2015 MESTINON
NDA #015193		 SUPPL-25 PYRIDOSTIGMINE BROMIDE BAUSCH Manufacturing (CMC) Approval
02/23/2015 MIOSTAT
NDA #016968		 SUPPL-28 CARBACHOL ALCON Manufacturing (CMC) Approval
02/23/2015 XYREM
NDA #021196		 SUPPL-20 SODIUM OXYBATE JAZZ PHARMS Manufacturing (CMC) Approval
02/23/2015 TOPOTECAN HYDROCHLORIDE
NDA #022453		 SUPPL-4 TOPOTECAN HYDROCHLORIDE MEITHEAL Manufacturing (CMC) Approval
02/23/2015 VIDAZA
NDA #050794		 SUPPL-27 AZACITIDINE BRISTOL-MYERS Manufacturing (CMC) Approval
02/23/2015 LABETALOL HYDROCHLORIDE
ANDA #075215		 SUPPL-18 LABETALOL HYDROCHLORIDE ANDAS 5 HOLDING Manufacturing (CMC) Approval
02/23/2015 DIGOXIN
ANDA #077002		 SUPPL-4 DIGOXIN HIKMA INTL PHARMS Manufacturing (CMC) Approval
02/23/2015 TOLTERODINE TARTRATE
ANDA #077006		 ORIG-1 TOLTERODINE TARTRATE IVAX SUB TEVA PHARMS Approval
02/23/2015 HYDROCORTISONE
ANDA #083365		 SUPPL-40 HYDROCORTISONE HIKMA INTL PHARMS Labeling Approval
02/23/2015 ZENATANE
ANDA #202099		 SUPPL-2 ISOTRETINOIN DR REDDYS LABS LTD Manufacturing (CMC) Approval
02/23/2015 SITAGLIPTIN PHOSPHATE
ANDA #202487		 ORIG-1 SITAGLIPTIN PHOSPHATE TEVA PHARMS USA Tentative Approval
02/23/2015 ASHLYNA
ANDA #203163		 ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL GLENMARK PHARMS LTD Approval
02/23/2015 IRBESARTAN
ANDA #203534		 ORIG-1 IRBESARTAN JUBILANT GENERICS Approval
02/23/2015 ADEMPAS
NDA #204819		 SUPPL-3 RIOCIGUAT BAYER HLTHCARE Manufacturing (CMC) Approval
02/23/2015 FARYDAK
NDA #205353		 ORIG-1 PANOBINOSTAT LACTATE SECURA Type 1 - New Molecular Entity Approval
02/24/2015 FERRIPROX
NDA #021825		 SUPPL-3 DEFERIPRONE CHIESI Labeling Approval
02/24/2015 DOXAZOSIN MESYLATE
ANDA #075509		 SUPPL-16 DOXAZOSIN MESYLATE AUROBINDO PHARMA USA Manufacturing (CMC) Approval
02/24/2015 MIVACURIUM CHLORIDE
ANDA #078562		 SUPPL-1 MIVACURIUM CHLORIDE RISING Labeling Approval
02/24/2015 NAPROXEN SODIUM
ANDA #079096		 SUPPL-2 NAPROXEN SODIUM AMNEAL PHARMS NY Manufacturing (CMC) Approval
02/24/2015 NAPROXEN SODIUM
ANDA #079096		 SUPPL-8 NAPROXEN SODIUM AMNEAL PHARMS NY Labeling Approval
02/24/2015 DIFICID
NDA #201699		 SUPPL-9 FIDAXOMICIN CUBIST PHARMS LLC Efficacy Approval
02/24/2015 MIGLITOL
ANDA #203965		 ORIG-1 MIGLITOL WESTMINSTER PHARMS Approval
02/25/2015 HUMULIN R
BLA #018780		 SUPPL-150 INSULIN HUMAN LILLY Approval
02/25/2015 HUMULIN R
BLA #018780		 SUPPL-150 INSULIN RECOMBINANT HUMAN LILLY Approval
02/25/2015 HUMULIN R KWIKPEN
BLA #018780		 SUPPL-150 INSULIN HUMAN LILLY Approval
02/25/2015 HUMULIN R PEN
BLA #018780		 SUPPL-150 INSULIN RECOMBINANT HUMAN LILLY Approval
02/25/2015 HUMULIN N
BLA #018781		 SUPPL-154 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
02/25/2015 HUMULIN 70/30
BLA #019717		 SUPPL-133 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
02/25/2015 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-133 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
02/25/2015 NOVOLIN N
BLA #019959		 SUPPL-75 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN NOVO NORDISK INC Approval
02/25/2015 HUMALOG
BLA #020563		 SUPPL-157 INSULIN LISPRO RECOMBINANT LILLY Approval
02/25/2015 HUMALOG KWIKPEN
BLA #020563		 SUPPL-157 INSULIN LISPRO RECOMBINANT LILLY Approval
02/25/2015 HUMALOG PEN
BLA #020563		 SUPPL-157 INSULIN LISPRO RECOMBINANT LILLY Approval
02/25/2015 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-157 INSULIN LISPRO RECOMBINANT LILLY Approval
02/25/2015 NOVOLOG
BLA #020986		 SUPPL-59 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 NOVOLOG
BLA #020986		 SUPPL-81 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 NOVOLOG FLEXPEN
BLA #020986		 SUPPL-59 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 NOVOLOG FLEXPEN
BLA #020986		 SUPPL-81 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 NOVOLOG FLEXTOUCH
BLA #020986		 SUPPL-59 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 NOVOLOG FLEXTOUCH
BLA #020986		 SUPPL-81 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 NOVOLOG INNOLET
BLA #020986		 SUPPL-59 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 NOVOLOG INNOLET
BLA #020986		 SUPPL-81 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 NOVOLOG PENFILL
BLA #020986		 SUPPL-59 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 NOVOLOG PENFILL
BLA #020986		 SUPPL-81 INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 HUMALOG MIX 75/25
BLA #021017		 SUPPL-108 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
02/25/2015 HUMALOG MIX 75/25 KWIKPEN
BLA #021017		 SUPPL-108 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
02/25/2015 HUMALOG MIX 75/25 PEN
BLA #021017		 SUPPL-108 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
02/25/2015 HUMALOG MIX 50/50
BLA #021018		 SUPPL-100 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
02/25/2015 HUMALOG MIX 50/50 KWIKPEN
BLA #021018		 SUPPL-100 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
02/25/2015 HUMALOG MIX 50/50 PEN
BLA #021018		 SUPPL-100 INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT LILLY Approval
02/25/2015 LANTUS
BLA #021081		 SUPPL-62 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
02/25/2015 LANTUS SOLOSTAR
BLA #021081		 SUPPL-62 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
02/25/2015 NOVOLOG MIX 70/30
BLA #021172		 SUPPL-46 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 NOVOLOG MIX 70/30
BLA #021172		 SUPPL-63 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 NOVOLOG MIX 70/30 FLEXPEN
BLA #021172		 SUPPL-46 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 NOVOLOG MIX 70/30 FLEXPEN
BLA #021172		 SUPPL-63 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 NOVOLOG MIX 70/30 PENFILL
BLA #021172		 SUPPL-46 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 NOVOLOG MIX 70/30 PENFILL
BLA #021172		 SUPPL-63 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 SYMLIN
NDA #021332		 SUPPL-23 PRAMLINTIDE ACETATE ASTRAZENECA AB Labeling Approval
02/25/2015 LEVEMIR
BLA #021536		 SUPPL-31 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 LEVEMIR
BLA #021536		 SUPPL-51 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 LEVEMIR FLEXPEN
BLA #021536		 SUPPL-31 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 LEVEMIR FLEXPEN
BLA #021536		 SUPPL-51 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 LEVEMIR FLEXTOUCH
BLA #021536		 SUPPL-31 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 LEVEMIR FLEXTOUCH
BLA #021536		 SUPPL-51 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 LEVEMIR INNOLET
BLA #021536		 SUPPL-31 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 LEVEMIR INNOLET
BLA #021536		 SUPPL-51 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 LEVEMIR PENFILL
BLA #021536		 SUPPL-31 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 LEVEMIR PENFILL
BLA #021536		 SUPPL-51 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 APIDRA
BLA #021629		 SUPPL-30 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
02/25/2015 APIDRA SOLOSTAR
BLA #021629		 SUPPL-30 INSULIN GLULISINE RECOMBINANT SANOFI AVENTIS US Approval
02/25/2015 BYETTA
NDA #021773		 SUPPL-40 EXENATIDE SYNTHETIC ASTRAZENECA AB Labeling Approval
02/25/2015 NOVOLOG MIX 50/50
BLA #021810		 SUPPL-10 INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT NOVO NORDISK INC Approval
02/25/2015 VICTOZA
NDA #022341		 SUPPL-22 LIRAGLUTIDE NOVO NORDISK INC Labeling Approval
02/25/2015 MINOCIN
NDA #050445		 SUPPL-29 MINOCYCLINE HYDROCHLORIDE BAUSCH Labeling Approval
02/25/2015 NEO-SYNALAR
ANDA #060700		 SUPPL-18 FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE MEDIMETRIKS PHARMS Manufacturing (CMC) Approval
02/25/2015 CEFUROXIME AXETIL
ANDA #065135		 SUPPL-15 CEFUROXIME AXETIL LUPIN Labeling Approval
02/25/2015 ONDANSETRON
ANDA #076693		 SUPPL-1 ONDANSETRON BARR Labeling Approval
02/25/2015 BUPROPION HYDROCHLORIDE
ANDA #077285		 SUPPL-30 BUPROPION HYDROCHLORIDE WATSON LABS INC Labeling Approval
02/25/2015 BUPROPION HYDROCHLORIDE
ANDA #077285		 SUPPL-32 BUPROPION HYDROCHLORIDE WATSON LABS INC Labeling Approval
02/25/2015 GLYBURIDE
ANDA #077537		 SUPPL-10 GLYBURIDE AUROBINDO PHARMA Labeling Approval
02/25/2015 GRANISETRON HYDROCHLORIDE
ANDA #078262		 SUPPL-2 GRANISETRON HYDROCHLORIDE AMNEAL Labeling Approval
02/25/2015 GRANISETRON HYDROCHLORIDE
ANDA #078564		 SUPPL-2 GRANISETRON HYDROCHLORIDE WOCKHARDT USA Labeling Approval
02/25/2015 GRANISETRON HYDROCHLORIDE
ANDA #078565		 SUPPL-2 GRANISETRON HYDROCHLORIDE WOCKHARDT USA Labeling Approval
02/25/2015 GRANISETRON HYDROCHLORIDE
ANDA #078566		 SUPPL-2 GRANISETRON HYDROCHLORIDE WOCKHARDT USA Labeling Approval
02/25/2015 SULFASALAZINE
ANDA #085828		 SUPPL-37 SULFASALAZINE WATSON LABS Labeling Approval
02/25/2015 SULFASALAZINE
ANDA #085828		 SUPPL-38 SULFASALAZINE WATSON LABS Labeling Approval
02/25/2015 PANTOPRAZOLE SODIUM
ANDA #090074		 SUPPL-10 PANTOPRAZOLE SODIUM TORRENT PHARMS Labeling Approval
02/25/2015 DONEPEZIL HYDROCHLORIDE
ANDA #090493		 SUPPL-3 DONEPEZIL HYDROCHLORIDE SUN PHARM INDS Labeling Approval
02/25/2015 DONEPEZIL HYDROCHLORIDE
ANDA #090521		 SUPPL-3 DONEPEZIL HYDROCHLORIDE NATCO PHARMA Labeling Approval
02/25/2015 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #091567		 SUPPL-1 FEXOFENADINE HYDROCHLORIDE SUN PHARM INDS Manufacturing (CMC) Approval
02/25/2015 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
ANDA #091567		 SUPPL-1 FEXOFENADINE HYDROCHLORIDE SUN PHARM INDS Manufacturing (CMC) Approval
02/25/2015 FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #091567		 SUPPL-1 FEXOFENADINE HYDROCHLORIDE SUN PHARM INDS Manufacturing (CMC) Approval
02/25/2015 FEXOFENADINE HYDROCHLORIDE HIVES
ANDA #091567		 SUPPL-1 FEXOFENADINE HYDROCHLORIDE SUN PHARM INDS Manufacturing (CMC) Approval
02/25/2015 METHYLERGONOVINE MALEATE
ANDA #091577		 SUPPL-3 METHYLERGONOVINE MALEATE CHARTWELL RX Manufacturing (CMC) Approval
02/25/2015 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #200218		 SUPPL-3 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE ANI PHARMS Labeling Approval
02/25/2015 LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
ANDA #200218		 SUPPL-5 AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE ANI PHARMS Labeling Approval
02/25/2015 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #200823		 SUPPL-5 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
02/25/2015 LEVETIRACETAM
ANDA #202958		 ORIG-1 LEVETIRACETAM APOTEX Approval
02/25/2015 OSPHENA
NDA #203505		 SUPPL-5 OSPEMIFENE DUCHESNAY Labeling Approval
02/25/2015 METHYLPHENIDATE HYDROCHLORIDE
ANDA #204115		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE NOVEL LABS INC Approval
02/25/2015 ALEVE PM
NDA #205352		 SUPPL-3 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM BAYER HLTHCARE Labeling Approval
02/25/2015 AVYCAZ
NDA #206494		 ORIG-1 AVIBACTAM SODIUM; CEFTAZIDIME ALLERGAN Type 1 - New Molecular Entity and Type 4 - New Combination Approval
02/25/2015 TOUJEO MAX SOLOSTAR
BLA #206538		 ORIG-1 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
02/25/2015 TOUJEO SOLOSTAR
BLA #206538		 ORIG-1 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
02/26/2015 CISPLATIN
NDA #018057		 SUPPL-83 CISPLATIN HQ SPCLT PHARMA Labeling Approval
02/26/2015 PLATINOL
NDA #018057		 SUPPL-83 CISPLATIN HQ SPCLT PHARMA Labeling Approval
02/26/2015 PLATINOL-AQ
NDA #018057		 SUPPL-83 CISPLATIN HQ SPCLT PHARMA Labeling Approval
02/26/2015 SUPRANE
NDA #020118		 SUPPL-20 DESFLURANE BAXTER HLTHCARE Labeling Approval
02/26/2015 INFANT'S ADVIL
NDA #020812		 SUPPL-22 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
02/26/2015 PEDIATRIC ADVIL
NDA #020812		 SUPPL-22 IBUPROFEN HALEON US HOLDINGS Manufacturing (CMC) Approval
02/26/2015 REYATAZ
NDA #021567		 SUPPL-36 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Labeling Approval
02/26/2015 NEUPRO
NDA #021829		 SUPPL-7 ROTIGOTINE UCB INC Labeling Approval
02/26/2015 TORISEL
NDA #022088		 SUPPL-18 TEMSIROLIMUS PF PRISM CV Labeling Approval
02/26/2015 FIRMAGON
NDA #022201		 SUPPL-9 DEGARELIX ACETATE FERRING Labeling Approval
02/26/2015 IBUPROFEN
ANDA #075682		 SUPPL-8 IBUPROFEN DR REDDYS LA Labeling Approval
02/26/2015 PROLIA
BLA #125320		 SUPPL-170 DENOSUMAB AMGEN Approval
02/26/2015 XGEVA
BLA #125320		 SUPPL-170 DENOSUMAB AMGEN Approval
02/26/2015 BINOSTO
NDA #202344		 SUPPL-7 ALENDRONATE SODIUM RADIUS Labeling Approval
02/26/2015 CISATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #203182		 ORIG-1 CISATRACURIUM BESYLATE FRESENIUS KABI USA Approval
02/26/2015 CISATRACURIUM BESYLATE
ANDA #203183		 ORIG-1 CISATRACURIUM BESYLATE FRESENIUS KABI USA Approval
02/26/2015 KYNAMRO
NDA #203568		 SUPPL-4 MIPOMERSEN SODIUM KASTLE THERAPS LLC Labeling Approval
02/26/2015 LILETTA
NDA #206229		 ORIG-1 LEVONORGESTREL MEDICINES360 Type 5 - New Formulation or New Manufacturer Approval
02/27/2015 MINIPRESS
NDA #017442		 SUPPL-43 PRAZOSIN HYDROCHLORIDE PFIZER Labeling Approval
02/27/2015 FELDENE
NDA #018147		 SUPPL-33 PIROXICAM PFIZER Labeling Approval
02/27/2015 FELDENE
NDA #018147		 SUPPL-38 PIROXICAM PFIZER Labeling Approval
02/27/2015 FELDENE
NDA #018147		 SUPPL-39 PIROXICAM PFIZER Labeling Approval
02/27/2015 FELDENE
NDA #018147		 SUPPL-40 PIROXICAM PFIZER Labeling Approval
02/27/2015 FELDENE
NDA #018147		 SUPPL-42 PIROXICAM PFIZER Labeling Approval
02/27/2015 CASODEX
NDA #020498		 SUPPL-25 BICALUTAMIDE ANI PHARMS Labeling Approval
02/27/2015 DITROPAN XL
NDA #020897		 SUPPL-33 OXYBUTYNIN CHLORIDE JANSSEN PHARMS Labeling Approval
02/27/2015 XYREM
NDA #021196		 SUPPL-15 SODIUM OXYBATE JAZZ PHARMS Labeling Approval
02/27/2015 METAXALONE
ANDA #040486		 ORIG-1 METAXALONE MOUNTAIN Approval
02/27/2015 LOPERAMIDE HYDROCHLORIDE
ANDA #074352		 SUPPL-4 LOPERAMIDE HYDROCHLORIDE SCIEGEN PHARMS INC Manufacturing (CMC) Approval
02/27/2015 OMEPRAZOLE
ANDA #075410		 SUPPL-42 OMEPRAZOLE LANNETT CO INC Labeling Approval
02/27/2015 OMEPRAZOLE
ANDA #075410		 SUPPL-45 OMEPRAZOLE LANNETT CO INC Labeling Approval
02/27/2015 OMEPRAZOLE
ANDA #075410		 SUPPL-48 OMEPRAZOLE LANNETT CO INC Labeling Approval
02/27/2015 OMEPRAZOLE
ANDA #075410		 SUPPL-49 OMEPRAZOLE LANNETT CO INC Labeling Approval
02/27/2015 FLUCONAZOLE
ANDA #079150		 SUPPL-6 FLUCONAZOLE AUROBINDO PHARMA Labeling Approval
02/27/2015 FLUCONAZOLE
ANDA #079150		 SUPPL-7 FLUCONAZOLE AUROBINDO PHARMA Labeling Approval
02/27/2015 FLUCONAZOLE
ANDA #079150		 SUPPL-8 FLUCONAZOLE AUROBINDO PHARMA Labeling Approval
02/27/2015 ESZOPICLONE
ANDA #091024		 SUPPL-1 ESZOPICLONE DR REDDYS Labeling Approval
02/27/2015 CAPECITABINE
ANDA #091649		 SUPPL-3 CAPECITABINE TEVA PHARMS USA Labeling Approval
02/27/2015 CARBIDOPA AND LEVODOPA
ANDA #202323		 SUPPL-2 CARBIDOPA; LEVODOPA ACCORD HLTHCARE Labeling Approval
02/27/2015 JUBLIA
NDA #203567		 SUPPL-2 EFINACONAZOLE BAUSCH Labeling Approval
02/27/2015 MONTELUKAST SODIUM
ANDA #203795		 ORIG-1 MONTELUKAST SODIUM JUBILANT GENERICS Approval
02/27/2015 CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
ANDA #204100		 ORIG-1 CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE MACLEODS PHARMS LTD Approval
02/27/2015 KERYDIN
NDA #204427		 SUPPL-3 TAVABOROLE ANACOR PHARMS INC Labeling Approval
02/27/2015 SODIUM FLUORIDE F-18
ANDA #204542		 ORIG-1 SODIUM FLUORIDE F-18 PRECISION NUCLEAR Approval
02/27/2015 FESOTERODINE FUMARATE
ANDA #205032		 ORIG-1 FESOTERODINE FUMARATE SUN PHARM INDS INC Tentative Approval
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