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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
November 2018

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 May 07, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
11/01/2018 HUMALOG
BLA #020563		 SUPPL-191 INSULIN LISPRO RECOMBINANT LILLY Approval
11/01/2018 HUMALOG KWIKPEN
BLA #020563		 SUPPL-191 INSULIN LISPRO RECOMBINANT LILLY Approval
11/01/2018 HUMALOG PEN
BLA #020563		 SUPPL-191 INSULIN LISPRO RECOMBINANT LILLY Approval
11/01/2018 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-191 INSULIN LISPRO RECOMBINANT LILLY Approval
11/01/2018 PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PRISMASOL BGK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PRISMASOL BGK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PRISMASOL BK 0/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-20 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 LIDOCAINE HYDROCHLORIDE
ANDA #040014		 SUPPL-7 LIDOCAINE HYDROCHLORIDE HIKMA Labeling Approval
11/01/2018 LIDOCAINE
ANDA #040911		 SUPPL-5 LIDOCAINE SEPTODONT INC Labeling Approval
11/01/2018 NICOTINE POLACRILEX
ANDA #203690		 SUPPL-17 NICOTINE POLACRILEX PERRIGO R AND D Manufacturing (CMC) Approval
11/01/2018 NICOTINE POLACRILEX
ANDA #203690		 SUPPL-18 NICOTINE POLACRILEX PERRIGO R AND D Manufacturing (CMC) Approval
11/01/2018 PROBUPHINE
NDA #204442		 SUPPL-7 BUPRENORPHINE HYDROCHLORIDE TITAN PHARMS REMS Approval
11/01/2018 HUMALOG KWIKPEN
BLA #205747		 SUPPL-18 INSULIN LISPRO RECOMBINANT ELI LILLY AND CO Approval
11/01/2018 PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER
NDA #207026		 SUPPL-6 CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER
NDA #207026		 SUPPL-6 CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE BAXTER HLTHCARE CORP Labeling Approval
11/01/2018 LINAGLIPTIN; METFORMIN HYDROCHLORIDE
ANDA #208430		 ORIG-1 LINAGLIPTIN;METFORMIN HYDROCHLORIDE MYLAN PHARMS INC Tentative Approval
11/01/2018 ADMELOG
BLA #209196		 SUPPL-2 INSULIN LISPRO SANOFI-AVENTIS US Approval
11/01/2018 ADMELOG SOLOSTAR
BLA #209196		 SUPPL-2 INSULIN LISPRO SANOFI-AVENTIS US Approval
11/01/2018 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA #209692		 ORIG-1 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN AMNEAL PHARMS Approval
11/01/2018 DOXERCALCIFEROL
ANDA #210801		 ORIG-1 DOXERCALCIFEROL LUPIN LTD Approval
11/01/2018 SYMPAZAN
NDA #210833		 ORIG-1 CLOBAZAM OTTER PHARMS Type 3 - New Dosage Form Approval
11/02/2018 XYLOCAINE
NDA #006488		 SUPPL-97 LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
11/02/2018 XYLOCAINE W/ EPINEPHRINE
NDA #006488		 SUPPL-97 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
11/02/2018 XYLOCAINE
NDA #008816		 SUPPL-39 LIDOCAINE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
11/02/2018 NESACAINE
NDA #009435		 SUPPL-44 CHLOROPROCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
11/02/2018 NESACAINE-MPF
NDA #009435		 SUPPL-44 CHLOROPROCAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
11/02/2018 CARBOCAINE
NDA #012250		 SUPPL-37 MEPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
11/02/2018 MARCAINE HYDROCHLORIDE
NDA #016964		 SUPPL-77 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
11/02/2018 MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
NDA #016964		 SUPPL-77 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
11/02/2018 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
NDA #016964		 SUPPL-77 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Labeling Approval
11/02/2018 MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
NDA #016964		 SUPPL-77 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Labeling Approval
11/02/2018 BUPIVACAINE HYDROCHLORIDE
NDA #018053		 SUPPL-60 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
11/02/2018 SENSORCAINE
NDA #018304		 SUPPL-49 BUPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
11/02/2018 SENSORCAINE
NDA #018304		 SUPPL-49 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE FRESENIUS KABI USA Labeling Approval
11/02/2018 MARCAINE
NDA #018692		 SUPPL-20 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
11/02/2018 RYTHMOL
NDA #019151		 SUPPL-15 PROPAFENONE HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
11/02/2018 EMLA
NDA #019941		 SUPPL-21 LIDOCAINE; PRILOCAINE TEVA BRANDED PHARM Labeling Approval
11/02/2018 NAROPIN
NDA #020533		 SUPPL-35 ROPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
11/02/2018 LIDODERM
NDA #020612		 SUPPL-14 LIDOCAINE TEIKOKU PHARMA USA Labeling Approval
11/02/2018 OPTIMARK
NDA #020937		 SUPPL-28 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
11/02/2018 SEPTOCAINE
NDA #020971		 SUPPL-42 ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE DEPROCO Labeling Approval
11/02/2018 OPTIMARK
NDA #020975		 SUPPL-29 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
11/02/2018 OPTIMARK IN PLASTIC CONTAINER
NDA #020976		 SUPPL-30 GADOVERSETAMIDE LIEBEL-FLARSHEIM Labeling Approval
11/02/2018 MULTIHANCE
NDA #021357		 SUPPL-18 GADOBENATE DIMEGLUMINE BRACCO Labeling Approval
11/02/2018 MULTIHANCE MULTIPACK
NDA #021358		 SUPPL-17 GADOBENATE DIMEGLUMINE BRACCO Labeling Approval
11/02/2018 XYLOCAINE DENTAL
NDA #021380		 SUPPL-7 LIDOCAINE HYDROCHLORIDE DENTSPLY PHARM Labeling Approval
11/02/2018 XYLOCAINE DENTAL WITH EPINEPHRINE
NDA #021381		 SUPPL-6 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE DENTSPLY PHARM Labeling Approval
11/02/2018 CITANEST PLAIN DENTAL
NDA #021382		 SUPPL-8 PRILOCAINE HYDROCHLORIDE DENTSPLY PHARM Labeling Approval
11/02/2018 CITANEST FORTE DENTAL
NDA #021383		 SUPPL-11 EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE DENTSPLY PHARM Labeling Approval
11/02/2018 RYTHMOL SR
NDA #021416		 SUPPL-15 PROPAFENONE HYDROCHLORIDE GLAXOSMITHKLINE LLC Labeling Approval
11/02/2018 ORAQIX
NDA #021451		 SUPPL-14 LIDOCAINE; PRILOCAINE DENTSPLY PHARM Labeling Approval
11/02/2018 NAMENDA
NDA #021487		 SUPPL-25 MEMANTINE HYDROCHLORIDE ABBVIE Labeling Approval
11/02/2018 PROHANCE MULTIPACK
NDA #021489		 SUPPL-10 GADOTERIDOL BRACCO Labeling Approval
11/02/2018 SYNERA
NDA #021623		 SUPPL-24 LIDOCAINE; TETRACAINE GALEN SPECIALTY Labeling Approval
11/02/2018 PLIAGLIS
NDA #021717		 SUPPL-11 LIDOCAINE; TETRACAINE TARO Labeling Approval
11/02/2018 BUPIVACAINE HYDROCHLORIDE
NDA #022046		 SUPPL-9 BUPIVACAINE HYDROCHLORIDE HOSPIRA Labeling Approval
11/02/2018 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
NDA #022046		 SUPPL-9 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE HOSPIRA Labeling Approval
11/02/2018 EOVIST
NDA #022090		 SUPPL-16 GADOXETATE DISODIUM BAYER HLTHCARE Labeling Approval
11/02/2018 ZINGO
NDA #022114		 SUPPL-4 LIDOCAINE HYDROCHLORIDE POWDER PHARMS Labeling Approval
11/02/2018 ORABLOC
NDA #022466		 SUPPL-5 ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE PIERREL Labeling Approval
11/02/2018 EXPAREL
NDA #022496		 SUPPL-30 BUPIVACAINE PACIRA PHARMS INC Labeling Approval
11/02/2018 LIDOCAINE HYDROCHLORIDE
ANDA #040014		 SUPPL-8 LIDOCAINE HYDROCHLORIDE HIKMA Labeling Approval
11/02/2018 LIDOCAINE HYDROCHLORIDE VISCOUS
ANDA #040708		 SUPPL-7 LIDOCAINE HYDROCHLORIDE CHARTWELL MOLECULAR Labeling Approval
11/02/2018 MEPIVACAINE HYDROCHLORIDE
ANDA #040806		 SUPPL-5 MEPIVACAINE HYDROCHLORIDE HOSPIRA INC Labeling Approval
11/02/2018 LIDOCAINE
ANDA #040911		 SUPPL-7 LIDOCAINE SEPTODONT INC Labeling Approval
11/02/2018 ERYTHROMYCIN ETHYLSUCCINATE
ANDA #062055		 SUPPL-34 ERYTHROMYCIN ETHYLSUCCINATE ANI PHARMS Manufacturing (CMC) Approval
11/02/2018 ERYTHROMYCIN ETHYLSUCCINATE
ANDA #062055		 SUPPL-35 ERYTHROMYCIN ETHYLSUCCINATE ANI PHARMS Manufacturing (CMC) Approval
11/02/2018 QUINAPRIL HYDROCHLORIDE
ANDA #076803		 SUPPL-4 QUINAPRIL HYDROCHLORIDE CHARTWELL RX Labeling Approval
11/02/2018 QUINAPRIL HYDROCHLORIDE
ANDA #076803		 SUPPL-5 QUINAPRIL HYDROCHLORIDE CHARTWELL RX Labeling Approval
11/02/2018 IRBESARTAN
ANDA #077159		 SUPPL-9 IRBESARTAN TEVA PHARMS Labeling Approval
11/02/2018 IRBESARTAN
ANDA #079213		 SUPPL-2 IRBESARTAN ZYDUS PHARMS USA INC Labeling Approval
11/02/2018 IRBESARTAN
ANDA #079213		 SUPPL-3 IRBESARTAN ZYDUS PHARMS USA INC Labeling Approval
11/02/2018 PRILOCAINE HYDROCHLORIDE
ANDA #079235		 SUPPL-5 PRILOCAINE HYDROCHLORIDE SEPTODONT INC Labeling Approval
11/02/2018 LIDOCAINE
ANDA #080198		 SUPPL-30 LIDOCAINE FOUGERA PHARMS INC Labeling Approval
11/02/2018 LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%
ANDA #083914		 SUPPL-40 LIDOCAINE HYDROCHLORIDE HOSPIRA Labeling Approval
11/02/2018 LIDOCAINE HYDROCHLORIDE VISCOUS
ANDA #086578		 SUPPL-40 LIDOCAINE HYDROCHLORIDE ACTAVIS MID ATLANTIC Labeling Approval
11/02/2018 LIDOCAINE
ANDA #086724		 SUPPL-33 LIDOCAINE TARO Labeling Approval
11/02/2018 LIDOCAINE
ANDA #086724		 SUPPL-35 LIDOCAINE TARO Labeling Approval
11/02/2018 LIDOCAINE HYDROCHLORIDE
ANDA #087872		 SUPPL-24 LIDOCAINE HYDROCHLORIDE WOCKHARDT BIO AG Labeling Approval
11/02/2018 SCANDONEST PLAIN
ANDA #088387		 SUPPL-38 MEPIVACAINE HYDROCHLORIDE DEPROCO Labeling Approval
11/02/2018 SCANDONEST L
ANDA #088388		 SUPPL-38 LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE DEPROCO Labeling Approval
11/02/2018 LIGNOSPAN FORTE
ANDA #088389		 SUPPL-43 EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE DEPROCO Labeling Approval
11/02/2018 LIGNOSPAN STANDARD
ANDA #088390		 SUPPL-52 EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE DEPROCO Labeling Approval
11/02/2018 LIDOCAINE VISCOUS
ANDA #088802		 SUPPL-25 LIDOCAINE HYDROCHLORIDE HIKMA Labeling Approval
11/02/2018 IRBESARTAN
ANDA #090720		 SUPPL-2 IRBESARTAN WATSON LABS INC Labeling Approval
11/02/2018 IRBESARTAN
ANDA #091236		 SUPPL-6 IRBESARTAN ALEMBIC PHARMS LTD Labeling Approval
11/02/2018 IRBESARTAN
ANDA #200461		 SUPPL-4 IRBESARTAN UPSHER SMITH LABS Labeling Approval
11/02/2018 GADAVIST
NDA #201277		 SUPPL-16 GADOBUTROL BAYER HLTHCARE Labeling Approval
11/02/2018 STRIBILD
NDA #203100		 SUPPL-33 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
11/02/2018 DOTAREM
NDA #204781		 SUPPL-9 GADOTERATE MEGLUMINE GUERBET Labeling Approval
11/02/2018 LIDOCAINE
ANDA #205318		 SUPPL-3 LIDOCAINE ENCUBE Labeling Approval
11/02/2018 IRBESARTAN
ANDA #206194		 SUPPL-2 IRBESARTAN HISUN PHARM HANGZHOU Labeling Approval
11/02/2018 LIDOCAINE
ANDA #206297		 SUPPL-8 LIDOCAINE AMNEAL PHARMS Labeling Approval
11/02/2018 LIDOCAINE
ANDA #206498		 SUPPL-2 LIDOCAINE GLENMARK PHARMS LTD Labeling Approval
11/02/2018 DICYCLOMINE HYDROCHLORIDE
ANDA #207076		 ORIG-1 DICYCLOMINE HYDROCHLORIDE SLATE RUN PHARMA Approval
11/02/2018 SOTALOL HYDROCHLORIDE
ANDA #207429		 ORIG-1 SOTALOL HYDROCHLORIDE BEXIMCO PHARMS USA Approval
11/02/2018 GENVOYA
NDA #207561		 SUPPL-20 COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Labeling Approval
11/02/2018 MIDODRINE HYDROCHLORIDE
ANDA #207613		 ORIG-1 MIDODRINE HYDROCHLORIDE THINQ PHARM-CRO PVT Approval
11/02/2018 LIDOCAINE
ANDA #207810		 SUPPL-2 LIDOCAINE ALKEM LABS LTD Labeling Approval
11/02/2018 ZTLIDO
NDA #207962		 SUPPL-1 LIDOCAINE SCILEX PHARMS Labeling Approval
11/02/2018 KOVANAZE
NDA #208032		 SUPPL-4 OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE ST RENATUS Labeling Approval
11/02/2018 LIDOCAINE
ANDA #208822		 SUPPL-1 LIDOCAINE VITRUVIAS THERAP Labeling Approval
11/02/2018 DSUVIA
NDA #209128		 ORIG-1 SUFENTANIL CITRATE VERTICAL PHARMS Type 3 - New Dosage Form Approval
11/02/2018 TERIFLUNOMIDE
ANDA #209601		 ORIG-1 TERIFLUNOMIDE APOTEX Approval
11/02/2018 METFORMIN HYDROCHLORIDE
ANDA #209674		 ORIG-1 METFORMIN HYDROCHLORIDE NOVAST LABS Approval
11/02/2018 LIDOCAINE
ANDA #210256		 SUPPL-1 LIDOCAINE TEVA PHARMS USA Labeling Approval
11/02/2018 LORBRENA
NDA #210868		 ORIG-1 LORLATINIB PFIZER Type 1 - New Molecular Entity Approval
11/02/2018 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #211528		 ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE APOTEX INC Tentative Approval
11/02/2018 UDENYCA
BLA #761039		 ORIG-1 PEGFILGRASTIM-CBQV COHERUS BIOSCIENCES INC Approval
11/03/2018 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019952		 SUPPL-38 HEPARIN SODIUM B BRAUN Labeling Approval
11/03/2018 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019952		 SUPPL-38 HEPARIN SODIUM B BRAUN Labeling Approval
11/05/2018 GEODON
NDA #020825		 SUPPL-59 ZIPRASIDONE HYDROCHLORIDE VIATRIS Labeling Approval
11/05/2018 GEODON
NDA #020919		 SUPPL-47 ZIPRASIDONE MESYLATE VIATRIS Labeling Approval
11/05/2018 BICILLIN C-R
NDA #050138		 SUPPL-239 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
11/05/2018 BICILLIN C-R 900/300
NDA #050138		 SUPPL-239 PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
11/05/2018 DYSPORT
BLA #125274		 SUPPL-112 abobotulinumtoxinA IPSEN BIOPHARM LTD Approval
11/05/2018 NORETHINDRONE ACETATE
ANDA #206490		 ORIG-1 NORETHINDRONE ACETATE NOVAST LABS Approval
11/05/2018 BUPROPION HYDROCHLORIDE
ANDA #207224		 SUPPL-3 BUPROPION HYDROCHLORIDE ANBISON LAB Manufacturing (CMC) Approval
11/05/2018 CLINDAMYCIN HYDROCHLORIDE
ANDA #207402		 ORIG-1 CLINDAMYCIN HYDROCHLORIDE MICRO LABS Approval
11/05/2018 OMEPRAZOLE
ANDA #207740		 ORIG-1 OMEPRAZOLE DR REDDYS Approval
11/05/2018 LEVALBUTEROL HYDROCHLORIDE
ANDA #207820		 ORIG-1 LEVALBUTEROL HYDROCHLORIDE SUN PHARM Approval
11/05/2018 LIDOCAINE
ANDA #208604		 SUPPL-1 LIDOCAINE RISING Labeling Approval
11/05/2018 NITYR
NDA #209449		 SUPPL-6 NITISINONE CYCLE Labeling Approval
11/05/2018 FLUOCINOLONE ACETONIDE
ANDA #210747		 ORIG-1 FLUOCINOLONE ACETONIDE COSETTE Approval
11/05/2018 ISOSORBIDE MONONITRATE
ANDA #210918		 ORIG-1 ISOSORBIDE MONONITRATE RICONPHARMA LLC Approval
11/06/2018 HUMULIN R
BLA #018780		 SUPPL-168 INSULIN HUMAN LILLY Approval
11/06/2018 HUMULIN R
BLA #018780		 SUPPL-168 INSULIN RECOMBINANT HUMAN LILLY Approval
11/06/2018 HUMULIN R KWIKPEN
BLA #018780		 SUPPL-168 INSULIN HUMAN LILLY Approval
11/06/2018 HUMULIN R PEN
BLA #018780		 SUPPL-168 INSULIN RECOMBINANT HUMAN LILLY Approval
11/06/2018 HUMULIN N
BLA #018781		 SUPPL-181 INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/06/2018 HUMULIN 70/30
BLA #019717		 SUPPL-161 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/06/2018 HUMULIN 70/30 PEN
BLA #019717		 SUPPL-161 INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN LILLY Approval
11/06/2018 CYSTADANE
NDA #020576		 SUPPL-14 BETAINE RECORDATI RARE Labeling Approval
11/06/2018 TRICOR
NDA #021203		 SUPPL-8 FENOFIBRATE ABBVIE Labeling Approval
11/06/2018 RIOMET
NDA #021591		 SUPPL-7 METFORMIN HYDROCHLORIDE RANBAXY Labeling Approval
11/06/2018 LIPOFEN
NDA #021612		 SUPPL-17 FENOFIBRATE CIPHER PHARMS INC Labeling Approval
11/06/2018 TRICOR
NDA #021656		 SUPPL-27 FENOFIBRATE ABBVIE Labeling Approval
11/06/2018 INTELENCE
NDA #022187		 SUPPL-23 ETRAVIRINE JANSSEN R AND D Efficacy Approval
11/06/2018 PRALUENT
BLA #125559		 SUPPL-18 ALIROCUMAB REGENERON PHARMACEUTICALS Approval
11/06/2018 PALONOSETRON HYDROCHLORIDE
ANDA #204702		 ORIG-1 PALONOSETRON HYDROCHLORIDE EUGIA PHARMA Approval
11/06/2018 BRYHALI
NDA #209355		 ORIG-1 HALOBETASOL PROPIONATE BAUSCH Type 3 - New Dosage Form Approval
11/06/2018 FROVATRIPTAN SUCCINATE
ANDA #211292		 ORIG-1 FROVATRIPTAN SUCCINATE AMNEAL PHARMS CO Approval
11/06/2018 EMPLICITI
BLA #761035		 SUPPL-8 ELOTUZUMAB BRISTOL MYERS SQUIBB Approval
11/07/2018 OMNISCAN
NDA #020123		 SUPPL-47 GADODIAMIDE GE HEALTHCARE Labeling Approval
11/07/2018 LUNESTA
NDA #021476		 SUPPL-36 ESZOPICLONE WAYLIS THERAP Labeling Approval
11/07/2018 ANTARA (MICRONIZED)
NDA #021695		 SUPPL-19 FENOFIBRATE LUPIN Labeling Approval
11/07/2018 GLUMETZA
NDA #021748		 SUPPL-25 METFORMIN HYDROCHLORIDE SANTARUS INC Labeling Approval
11/07/2018 OMNISCAN
NDA #022066		 SUPPL-9 GADODIAMIDE GE HEALTHCARE Labeling Approval
11/07/2018 TRILIPIX
NDA #022224		 SUPPL-14 CHOLINE FENOFIBRATE ABBVIE Labeling Approval
11/07/2018 XARELTO
NDA #022406		 SUPPL-29 RIVAROXABAN JANSSEN PHARMS Labeling Approval
11/07/2018 BICILLIN L-A
NDA #050141		 SUPPL-236 PENICILLIN G BENZATHINE KING PHARMS LLC Labeling Approval
11/07/2018 CIPROFLOXACIN
ANDA #076558		 SUPPL-41 CIPROFLOXACIN HIKMA Labeling Approval
11/07/2018 CIPROFLOXACIN
ANDA #076558		 SUPPL-46 CIPROFLOXACIN HIKMA Labeling Approval
11/07/2018 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076558		 SUPPL-41 CIPROFLOXACIN HYDROCHLORIDE HIKMA Labeling Approval
11/07/2018 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076558		 SUPPL-46 CIPROFLOXACIN HYDROCHLORIDE HIKMA Labeling Approval
11/07/2018 NOREPINEPHRINE BITARTRATE
ANDA #203662		 ORIG-1 NOREPINEPHRINE BITARTRATE HIKMA Approval
11/07/2018 PRIMATENE MIST
NDA #205920		 ORIG-1 EPINEPHRINE ARMSTRONG PHARMS Type 5 - New Formulation or New Manufacturer Approval
11/07/2018 TETRACYCLINE HYDROCHLORIDE
ANDA #210662		 ORIG-1 TETRACYCLINE HYDROCHLORIDE BRECKENRIDGE Approval
11/07/2018 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #211487		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE ASCENT PHARMS INC Approval
11/08/2018 MARPLAN
NDA #011961		 SUPPL-45 ISOCARBOXAZID VALIDUS PHARMS INC Labeling Approval
11/08/2018 FOSRENOL
NDA #021468		 SUPPL-21 LANTHANUM CARBONATE TAKEDA PHARMS USA Labeling Approval
11/08/2018 FORTAMET
NDA #021574		 SUPPL-17 METFORMIN HYDROCHLORIDE ANDRX LABS LLC Labeling Approval
11/08/2018 SEROMYCIN
ANDA #060593		 SUPPL-35 CYCLOSERINE CEROVENE INC Labeling Approval
11/08/2018 SEROMYCIN
ANDA #060593		 SUPPL-36 CYCLOSERINE CEROVENE INC Labeling Approval
11/08/2018 SEROMYCIN
ANDA #060593		 SUPPL-37 CYCLOSERINE CEROVENE INC Labeling Approval
11/08/2018 SEROMYCIN
ANDA #060593		 SUPPL-38 CYCLOSERINE CEROVENE INC Labeling Approval
11/08/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202741		 SUPPL-2 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MYLAN LABS LTD Labeling Approval
11/08/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202741		 SUPPL-3 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MYLAN LABS LTD Labeling Approval
11/08/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #202742		 SUPPL-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MYLAN LABS LTD Labeling Approval
11/08/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #202742		 SUPPL-3 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MYLAN LABS LTD Labeling Approval
11/08/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #202742		 SUPPL-4 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MYLAN LABS LTD Labeling Approval
11/08/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202770		 SUPPL-2 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MYLAN LABS LTD Labeling Approval
11/08/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202770		 SUPPL-3 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MYLAN LABS LTD Labeling Approval
11/08/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202771		 SUPPL-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MYLAN LABS LTD Labeling Approval
11/08/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202771		 SUPPL-3 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MYLAN LABS LTD Labeling Approval
11/08/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202772		 SUPPL-2 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MYLAN LABS LTD Labeling Approval
11/08/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #202772		 SUPPL-3 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MYLAN LABS LTD Labeling Approval
11/08/2018 BIMATOPROST
ANDA #203299		 ORIG-1 BIMATOPROST HIKMA Approval
11/08/2018 GANCICLOVIR SODIUM
ANDA #204204		 ORIG-1 GANCICLOVIR SODIUM SLATE RUN PHARMA Approval
11/08/2018 FOSRENOL
NDA #204734		 SUPPL-3 LANTHANUM CARBONATE TAKEDA PHARMS USA Labeling Approval
11/08/2018 NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #207764		 ORIG-1 NYSTATIN; TRIAMCINOLONE ACETONIDE ZYDUS LIFESCIENCES Approval
11/08/2018 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #208540		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE ALVOGEN Approval
11/09/2018 NORPRAMIN
NDA #014399		 SUPPL-71 DESIPRAMINE HYDROCHLORIDE VALIDUS PHARMS Labeling Approval
11/09/2018 AGGRENOX
NDA #020884		 SUPPL-37 ASPIRIN; DIPYRIDAMOLE BOEHRINGER INGELHEIM Labeling Approval
11/09/2018 CRESTOR
NDA #021366		 SUPPL-38 ROSUVASTATIN CALCIUM IPR Labeling Approval
11/09/2018 EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #091215		 ORIG-1 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TEVA PHARMS USA Approval
11/09/2018 KEYTRUDA
BLA #125514		 SUPPL-42 PEMBROLIZUMAB MERCK SHARP DOHME Approval
11/09/2018 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #201896		 SUPPL-1 ETHINYL ESTRADIOL; NORGESTIMATE MYLAN Labeling Approval
11/09/2018 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #201896		 SUPPL-2 ETHINYL ESTRADIOL; NORGESTIMATE MYLAN Labeling Approval
11/09/2018 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #201897		 SUPPL-1 ETHINYL ESTRADIOL; NORGESTIMATE MYLAN Labeling Approval
11/09/2018 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #201897		 SUPPL-2 ETHINYL ESTRADIOL; NORGESTIMATE MYLAN Labeling Approval
11/09/2018 TUDORZA PRESSAIR
NDA #202450		 SUPPL-11 ACLIDINIUM BROMIDE COVIS Labeling Approval
11/09/2018 ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE
ANDA #204209		 SUPPL-6 ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE LARKEN LABS INC Labeling Approval
11/09/2018 OFEV
NDA #205832		 SUPPL-10 NINTEDANIB ESYLATE BOEHRINGER INGELHEIM Labeling Approval
11/09/2018 ANASTROZOLE
ANDA #206037		 ORIG-1 ANASTROZOLE BEIJING YILING Approval
11/09/2018 VALGANCICLOVIR HYDROCHLORIDE
ANDA #209672		 ORIG-1 VALGANCICLOVIR HYDROCHLORIDE CIPLA Approval
11/09/2018 DOXYCYCLINE HYCLATE
ANDA #209969		 ORIG-1 DOXYCYCLINE HYCLATE AVET LIFESCIENCES Approval
11/09/2018 DIMETHYL FUMARATE
ANDA #210291		 ORIG-1 DIMETHYL FUMARATE SHILPA MEDICARE LTD Tentative Approval
11/09/2018 BENZONATATE
ANDA #210562		 ORIG-1 BENZONATATE CHARTWELL RX Approval
11/09/2018 YUPELRI
NDA #210598		 ORIG-1 REVEFENACIN MYLAN IRELAND LTD Type 1 - New Molecular Entity Approval
11/09/2018 DECITABINE
ANDA #210756		 ORIG-1 DECITABINE LUPIN LTD Approval
11/09/2018 BUDESONIDE
ANDA #210897		 ORIG-1 BUDESONIDE LUPIN Approval
11/11/2018 PEPCID
NDA #019462		 SUPPL-40 FAMOTIDINE BAUSCH Labeling Approval
11/11/2018 VIMPAT
NDA #022253		 SUPPL-42 LACOSAMIDE UCB INC Labeling Approval
11/11/2018 VIMPAT
NDA #022254		 SUPPL-33 LACOSAMIDE UCB INC Labeling Approval
11/11/2018 VIMPAT
NDA #022255		 SUPPL-24 LACOSAMIDE UCB INC Labeling Approval
11/12/2018 MONUROL
NDA #050717		 SUPPL-10 FOSFOMYCIN TROMETHAMINE ZAMBON SPA Labeling Approval
11/12/2018 OCREVUS
BLA #761053		 SUPPL-12 OCRELIZUMAB GENENTECH INC Approval
11/13/2018 SUDAFED 24 HOUR
NDA #020021		 SUPPL-12 PSEUDOEPHEDRINE HYDROCHLORIDE J AND J CONSUMER INC Labeling Approval
11/13/2018 CARISOPRODOL
ANDA #040792		 SUPPL-14 CARISOPRODOL AUROBINDO PHARMA Labeling Approval
11/13/2018 CARISOPRODOL
ANDA #205126		 SUPPL-4 CARISOPRODOL WILSHIRE PHARMS INC Labeling Approval
11/13/2018 ARSENIC TRIOXIDE
ANDA #206228		 ORIG-1 ARSENIC TRIOXIDE ZYDUS PHARMS Approval
11/13/2018 TICAGRELOR
ANDA #210219		 ORIG-1 TICAGRELOR ALKEM LABS LTD Tentative Approval
11/13/2018 BENDAMUSTINE HYDROCHLORIDE
ANDA #210410		 ORIG-1 BENDAMUSTINE HYDROCHLORIDE FRESENIUS KABI USA Tentative Approval
11/13/2018 BENDAMUSTINE HYDROCHLORIDE
ANDA #210601		 ORIG-1 BENDAMUSTINE HYDROCHLORIDE APOTEX INC Tentative Approval
11/13/2018 ARSENIC TRIOXIDE
ANDA #210802		 ORIG-1 ARSENIC TRIOXIDE AMRING PHARMS Approval
11/13/2018 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ANDA #210819		 ORIG-1 ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE BAYSHORE PHARMS LLC Approval
11/14/2018 NICORETTE
NDA #018612		 SUPPL-81 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
11/14/2018 NICORETTE (MINT)
NDA #018612		 SUPPL-81 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
11/14/2018 ADVIL
NDA #018989		 SUPPL-91 IBUPROFEN HALEON US HOLDINGS Labeling Approval
11/14/2018 NICORETTE
NDA #020066		 SUPPL-62 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
11/14/2018 NICORETTE (MINT)
NDA #020066		 SUPPL-62 NICOTINE POLACRILEX HALEON US HOLDINGS Labeling Approval
11/14/2018 SUDAFED 12 HOUR
ANDA #073585		 SUPPL-19 PSEUDOEPHEDRINE HYDROCHLORIDE MCNEIL CONS Labeling Approval
11/14/2018 ALFUZOSIN HYDROCHLORIDE
ANDA #079014		 SUPPL-8 ALFUZOSIN HYDROCHLORIDE MYLAN Labeling Approval
11/14/2018 ALFUZOSIN HYDROCHLORIDE
ANDA #079057		 SUPPL-12 ALFUZOSIN HYDROCHLORIDE SUN PHARM Labeling Approval
11/14/2018 LETROZOLE
ANDA #205869		 ORIG-1 LETROZOLE BEIJING YILING Approval
11/14/2018 FONDAPARINUX SODIUM
ANDA #208615		 ORIG-1 FONDAPARINUX SODIUM SCINOPHARM TAIWAN Approval
11/15/2018 OSMITROL 10% IN WATER
NDA #013684		 SUPPL-98 MANNITOL BAXTER HLTHCARE Labeling Approval
11/15/2018 OSMITROL 10% IN WATER
NDA #013684		 SUPPL-104 MANNITOL BAXTER HLTHCARE Efficacy Approval
11/15/2018 OSMITROL 10% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-98 MANNITOL BAXTER HLTHCARE Labeling Approval
11/15/2018 OSMITROL 10% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-104 MANNITOL BAXTER HLTHCARE Efficacy Approval
11/15/2018 OSMITROL 15% IN WATER
NDA #013684		 SUPPL-98 MANNITOL BAXTER HLTHCARE Labeling Approval
11/15/2018 OSMITROL 15% IN WATER
NDA #013684		 SUPPL-104 MANNITOL BAXTER HLTHCARE Efficacy Approval
11/15/2018 OSMITROL 15% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-98 MANNITOL BAXTER HLTHCARE Labeling Approval
11/15/2018 OSMITROL 15% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-104 MANNITOL BAXTER HLTHCARE Efficacy Approval
11/15/2018 OSMITROL 20% IN WATER
NDA #013684		 SUPPL-98 MANNITOL BAXTER HLTHCARE Labeling Approval
11/15/2018 OSMITROL 20% IN WATER
NDA #013684		 SUPPL-104 MANNITOL BAXTER HLTHCARE Efficacy Approval
11/15/2018 OSMITROL 20% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-98 MANNITOL BAXTER HLTHCARE Labeling Approval
11/15/2018 OSMITROL 20% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-104 MANNITOL BAXTER HLTHCARE Efficacy Approval
11/15/2018 OSMITROL 5% IN WATER
NDA #013684		 SUPPL-98 MANNITOL BAXTER HLTHCARE Labeling Approval
11/15/2018 OSMITROL 5% IN WATER
NDA #013684		 SUPPL-104 MANNITOL BAXTER HLTHCARE Efficacy Approval
11/15/2018 OSMITROL 5% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-98 MANNITOL BAXTER HLTHCARE Labeling Approval
11/15/2018 OSMITROL 5% IN WATER IN PLASTIC CONTAINER
NDA #013684		 SUPPL-104 MANNITOL BAXTER HLTHCARE Efficacy Approval
11/15/2018 NORVIR
NDA #020659		 SUPPL-69 RITONAVIR ABBVIE Labeling Approval
11/15/2018 NORVIR
NDA #020945		 SUPPL-45 RITONAVIR ABBVIE Labeling Approval
11/15/2018 EPIVIR-HBV
NDA #021003		 SUPPL-20 LAMIVUDINE GLAXOSMITHKLINE Efficacy Approval
11/15/2018 EPIVIR-HBV
NDA #021004		 SUPPL-20 LAMIVUDINE GLAXOSMITHKLINE Efficacy Approval
11/15/2018 KALETRA
NDA #021226		 SUPPL-46 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
11/15/2018 KALETRA
NDA #021251		 SUPPL-56 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
11/15/2018 KALETRA
NDA #021906		 SUPPL-51 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
11/15/2018 SPRYCEL
NDA #021986		 SUPPL-23 DASATINIB BRISTOL MYERS SQUIBB Labeling Approval
11/15/2018 NORVIR
NDA #022417		 SUPPL-21 RITONAVIR ABBVIE Labeling Approval
11/15/2018 ABACAVIR SULFATE AND LAMIVUDINE
ANDA #090159		 ORIG-1 ABACAVIR SULFATE; LAMIVUDINE AUROBINDO PHARMA LTD Approval
11/15/2018 OPDIVO
BLA #125554		 SUPPL-69 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
11/15/2018 PROPOFOL
ANDA #205067		 ORIG-1 PROPOFOL DR REDDYS Approval
11/15/2018 KETOROLAC TROMETHAMINE
ANDA #205191		 ORIG-1 KETOROLAC TROMETHAMINE EUGIA PHARMA Approval
11/15/2018 ABACAVIR SULFATE AND LAMIVUDINE
ANDA #208990		 ORIG-1 ABACAVIR SULFATE; LAMIVUDINE ZYDUS PHARMS Approval
11/15/2018 RADICAVA
NDA #209176		 SUPPL-7 EDARAVONE MITSUBISHI TANABE Manufacturing (CMC) Approval
11/15/2018 ARSENIC TRIOXIDE
ANDA #209315		 ORIG-1 ARSENIC TRIOXIDE INGENUS PHARMS LLC Approval
11/15/2018 NORVIR
NDA #209512		 SUPPL-4 RITONAVIR ABBVIE Labeling Approval
11/15/2018 TERIFLUNOMIDE
ANDA #209663		 ORIG-1 TERIFLUNOMIDE GLENMARK PHARMS Approval
11/15/2018 ARSENIC TRIOXIDE
ANDA #209780		 ORIG-1 ARSENIC TRIOXIDE NEXUS Approval
11/16/2018 HEPARIN SODIUM
NDA #017029		 SUPPL-141 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
11/16/2018 HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%
NDA #017029		 SUPPL-141 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
11/16/2018 HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%
NDA #017029		 SUPPL-141 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
11/16/2018 HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #017029		 SUPPL-141 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
11/16/2018 HEPARIN SODIUM IN PLASTIC CONTAINER
NDA #017029		 SUPPL-141 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
11/16/2018 HEPARIN SODIUM PRESERVATIVE FREE
NDA #017029		 SUPPL-141 HEPARIN SODIUM FRESENIUS KABI USA Labeling Approval
11/16/2018 TOTECT
NDA #022025		 SUPPL-18 DEXRAZOXANE HYDROCHLORIDE CLINIGEN Labeling Approval
11/16/2018 PROMACTA
NDA #022291		 SUPPL-21 ELTROMBOPAG OLAMINE NOVARTIS Efficacy Approval
11/16/2018 LINCOCIN
NDA #050317		 SUPPL-183 LINCOMYCIN HYDROCHLORIDE PFIZER Labeling Approval
11/16/2018 MINOCIN
NDA #050445		 SUPPL-30 MINOCYCLINE HYDROCHLORIDE BAUSCH Labeling Approval
11/16/2018 ELAPRASE
BLA #125151		 SUPPL-197 IDURSULFASE SHIRE Approval
11/16/2018 ADCETRIS
BLA #125388		 SUPPL-99 BRENTUXIMAB VEDOTIN SEATTLE GENETICS Approval
11/16/2018 MITIGARE
NDA #204820		 SUPPL-4 COLCHICINE HIKMA INTL PHARMS Manufacturing (CMC) Approval
11/16/2018 NAPROXEN SODIUM
ANDA #207612		 ORIG-1 NAPROXEN SODIUM NOVELGENIX THERAPS Approval
11/16/2018 VARDENAFIL HYDROCHLORIDE
ANDA #208324		 ORIG-1 VARDENAFIL HYDROCHLORIDE ALEMBIC Approval
11/16/2018 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #209924		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE NOSTRUM LABS INC Approval
11/16/2018 CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #210719		 ORIG-1 CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE PERRIGO R AND D Approval
11/16/2018 AEMCOLO
NDA #210910		 ORIG-1 RIFAMYCIN SODIUM REDHILL Type 1 - New Molecular Entity Approval
11/16/2018 TEMIXYS
NDA #211284		 ORIG-1 LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE CHARTWELL RX Type 5 - New Formulation or New Manufacturer Approval
11/16/2018 SUCCINYLCHOLINE CHLORIDE
ANDA #211432		 ORIG-1 SUCCINYLCHOLINE CHLORIDE AMNEAL Approval
11/16/2018 TAKHZYRO
BLA #761090		 SUPPL-1 LANADELUMAB-FLYO DYAX CORP. Approval
11/19/2018 ACTEMRA
BLA #125276		 SUPPL-118 TOCILIZUMAB GENENTECH Approval
11/19/2018 ACTEMRA
BLA #125472		 SUPPL-29 TOCILIZUMAB GENENTECH Approval
11/19/2018 RAMIPRIL
ANDA #202392		 SUPPL-2 RAMIPRIL ACCORD HLTHCARE Labeling Approval
11/19/2018 RAMIPRIL
ANDA #202392		 SUPPL-3 RAMIPRIL ACCORD HLTHCARE Labeling Approval
11/19/2018 ZOLEDRONIC ACID
ANDA #204344		 ORIG-1 ZOLEDRONIC ACID DR REDDYS Approval
11/19/2018 AZELAIC ACID
ANDA #204637		 ORIG-1 AZELAIC ACID GLENMARK PHARMS Approval
11/19/2018 NATEGLINIDE
ANDA #205248		 SUPPL-1 NATEGLINIDE ZYDUS PHARMS Labeling Approval
11/19/2018 NATEGLINIDE
ANDA #205248		 SUPPL-2 NATEGLINIDE ZYDUS PHARMS Labeling Approval
11/19/2018 OLANZAPINE
ANDA #206238		 ORIG-1 OLANZAPINE SUNSHINE Approval
11/19/2018 QVAR REDIHALER
NDA #207921		 SUPPL-3 BECLOMETHASONE DIPROPIONATE NORTON WATERFORD Manufacturing (CMC) Tentative Approval
11/19/2018 AZELAIC ACID
ANDA #208011		 ORIG-1 AZELAIC ACID ACTAVIS LABS UT INC Approval
11/19/2018 RABEPRAZOLE SODIUM
ANDA #208644		 SUPPL-2 RABEPRAZOLE SODIUM ALKEM LABS LTD Labeling Approval
11/19/2018 AZELAIC ACID
ANDA #208724		 ORIG-1 AZELAIC ACID ENCUBE Approval
11/19/2018 DOCOSANOL
ANDA #208754		 ORIG-1 DOCOSANOL P AND L Approval
11/19/2018 HEPARIN SODIUM
ANDA #208827		 ORIG-1 HEPARIN SODIUM B BRAUN MEDICAL INC Approval
11/20/2018 GEMZAR
NDA #020509		 SUPPL-81 GEMCITABINE HYDROCHLORIDE LILLY Labeling Approval
11/20/2018 BIMATOPROST
ANDA #090449		 SUPPL-3 BIMATOPROST APOTEX Manufacturing (CMC) Approval
11/20/2018 CALCIUM ACETATE
ANDA #091312		 SUPPL-1 CALCIUM ACETATE CHARTWELL RX Manufacturing (CMC) Approval
11/20/2018 DYCLOPRO
ANDA #200480		 ORIG-1 DYCLONINE HYDROCHLORIDE SEPTODONT Approval
11/20/2018 MESALAMINE
ANDA #203574		 ORIG-1 MESALAMINE MYLAN Approval
11/20/2018 TREPROSTINIL
ANDA #203649		 SUPPL-2 TREPROSTINIL SANDOZ Labeling Approval
11/20/2018 TREPROSTINIL
ANDA #203649		 SUPPL-4 TREPROSTINIL SANDOZ Labeling Approval
11/20/2018 TREPROSTINIL
ANDA #203649		 SUPPL-5 TREPROSTINIL SANDOZ Labeling Approval
11/20/2018 BUPRENORPHINE
ANDA #204937		 ORIG-1 BUPRENORPHINE WATSON LABS TEVA Approval
11/20/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #205049		 SUPPL-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MYLAN LABS LTD Labeling Approval
11/20/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #205049		 SUPPL-2 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE MYLAN LABS LTD Labeling Approval
11/20/2018 ATORVASTATIN CALCIUM
ANDA #206536		 ORIG-1 ATORVASTATIN CALCIUM ZYDUS PHARMS Approval
11/20/2018 IMATINIB MESYLATE
ANDA #207586		 SUPPL-1 IMATINIB MESYLATE HIKMA Manufacturing (CMC) Approval
11/20/2018 IMATINIB MESYLATE
ANDA #207586		 SUPPL-2 IMATINIB MESYLATE HIKMA Labeling Approval
11/20/2018 READYPREP CHG
NDA #207964		 ORIG-1 CHLORHEXIDINE GLUCONATE MEDLINE INDUSTRIES Type 5 - New Formulation or New Manufacturer Approval
11/20/2018 VIGABATRIN
ANDA #211481		 ORIG-1 VIGABATRIN DR REDDYS Approval
11/20/2018 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #211551		 ORIG-1 LEVOCETIRIZINE DIHYDROCHLORIDE MICRO LABS Approval
11/20/2018 GAMIFANT
BLA #761107		 ORIG-1 EMAPALUMAB-LZSG NOVIMMUNE S.A. Approval
11/21/2018 DENAVIR
NDA #020629		 SUPPL-19 PENCICLOVIR MYLAN Labeling Approval
11/21/2018 ZEMPLAR
NDA #020819		 SUPPL-30 PARICALCITOL ABBVIE Labeling Approval
11/21/2018 HECTOROL
NDA #020862		 SUPPL-31 DOXERCALCIFEROL SANOFI Labeling Approval
11/21/2018 HECTOROL
NDA #021027		 SUPPL-34 DOXERCALCIFEROL SANOFI Labeling Approval
11/21/2018 CHILDREN'S CLARITIN
NDA #021891		 SUPPL-29 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
11/21/2018 CLARITIN
NDA #021891		 SUPPL-29 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
11/21/2018 TRESIBA
BLA #203314		 SUPPL-10 INSULIN DEGLUDEC NOVO Approval
11/21/2018 VENLAFAXINE HYDROCHLORIDE
ANDA #206250		 ORIG-1 VENLAFAXINE HYDROCHLORIDE CADILA PHARMS LTD Approval
11/21/2018 VENCLEXTA
NDA #208573		 SUPPL-9 VENETOCLAX ABBVIE Efficacy Approval
11/21/2018 CLOMIPRAMINE HYDROCHLORIDE
ANDA #209294		 ORIG-1 CLOMIPRAMINE HYDROCHLORIDE LUPIN LTD Approval
11/21/2018 DICLOFENAC SODIUM
ANDA #209484		 ORIG-1 DICLOFENAC SODIUM HIKMA Approval
11/21/2018 ATOVAQUONE
ANDA #209685		 ORIG-1 ATOVAQUONE GLENMARK PHARMS Approval
11/21/2018 CALCITRIOL
ANDA #209798		 ORIG-1 CALCITRIOL RISING Approval
11/21/2018 POTASSIUM CHLORIDE
ANDA #210241		 ORIG-1 POTASSIUM CHLORIDE NOVEL LABS INC Approval
11/21/2018 DAURISMO
NDA #210656		 ORIG-1 GLASDEGIB MALEATE PFIZER Type 1 - New Molecular Entity Approval
11/21/2018 METHYLPHENIDATE HYDROCHLORIDE
ANDA #210992		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE GRANULES Approval
11/21/2018 FLUOXETINE HYDROCHLORIDE
ANDA #211477		 ORIG-1 FLUOXETINE HYDROCHLORIDE TARO Approval
11/21/2018 SPY AGENT GREEN KIT
NDA #211580		 ORIG-1 INDOCYANINE GREEN NOVADAQ TECH Type 5 - New Formulation or New Manufacturer Approval
11/23/2018 AQUAMEPHYTON
NDA #012223		 SUPPL-42 PHYTONADIONE PAI HOLDINGS PHARM Labeling Approval
11/23/2018 VENLAFAXINE HYDROCHLORIDE
ANDA #201272		 ORIG-1 VENLAFAXINE HYDROCHLORIDE INTELLIPHARMACEUTICS Approval
11/23/2018 PRAVASTATIN SODIUM
ANDA #206061		 ORIG-1 PRAVASTATIN SODIUM HISUN PHARM HANGZHOU Approval
11/23/2018 ROFLUMILAST
ANDA #208213		 ORIG-1 ROFLUMILAST HETERO LABS LTD III Approval
11/23/2018 EPTIFIBATIDE
ANDA #208554		 ORIG-1 EPTIFIBATIDE BAXTER HLTHCARE CORP Approval
11/23/2018 LACTULOSE
ANDA #209517		 ORIG-1 LACTULOSE CHARTWELL RX Approval
11/23/2018 TRIAMCINOLONE ACETONIDE
ANDA #209828		 ORIG-1 TRIAMCINOLONE ACETONIDE MACLEODS PHARMS LTD Approval
11/23/2018 POTASSIUM CHLORIDE
ANDA #210200		 ORIG-1 POTASSIUM CHLORIDE EPIC PHARMA LLC Approval
11/23/2018 IBUPROFEN
ANDA #210602		 ORIG-1 IBUPROFEN APTAPHARMA INC Approval
11/23/2018 RANITIDINE HYDROCHLORIDE
ANDA #210681		 ORIG-1 RANITIDINE HYDROCHLORIDE NOVITIUM PHARMA Approval
11/23/2018 LEUCOVORIN CALCIUM
ANDA #210917		 ORIG-1 LEUCOVORIN CALCIUM NOVAST LABS Approval
11/23/2018 LIDOCAINE
ANDA #211469		 ORIG-1 LIDOCAINE ALEMBIC Approval
11/23/2018 TEMAZEPAM
ANDA #211542		 ORIG-1 TEMAZEPAM ALEMBIC Approval
11/23/2018 BACLOFEN
ANDA #211659		 ORIG-1 BACLOFEN ZYDUS LIFESCIENCES Approval
11/25/2018 BIAXIN
NDA #050662		 SUPPL-59 CLARITHROMYCIN ABBVIE Labeling Approval
11/25/2018 BIAXIN
NDA #050698		 SUPPL-39 CLARITHROMYCIN ABBVIE Labeling Approval
11/25/2018 BIAXIN XL
NDA #050775		 SUPPL-27 CLARITHROMYCIN ABBVIE Labeling Approval
11/26/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #076798		 SUPPL-3 PIOGLITAZONE HYDROCHLORIDE CHARTWELL RX Labeling Approval
11/26/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #076798		 SUPPL-4 PIOGLITAZONE HYDROCHLORIDE CHARTWELL RX Labeling Approval
11/26/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #077210		 SUPPL-2 PIOGLITAZONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
11/26/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #077210		 SUPPL-3 PIOGLITAZONE HYDROCHLORIDE TEVA PHARMS USA Labeling Approval
11/26/2018 CYRAMZA
BLA #125477		 SUPPL-31 RAMUCIRUMAB ELI LILLY AND CO Approval
11/26/2018 GLIMEPIRIDE
ANDA #202112		 SUPPL-5 GLIMEPIRIDE INDOCO REMEDIES Labeling Approval
11/26/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #202456		 SUPPL-1 PIOGLITAZONE HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/26/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #202456		 SUPPL-2 PIOGLITAZONE HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/26/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #202456		 SUPPL-3 PIOGLITAZONE HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
11/26/2018 CINACALCET HYDROCHLORIDE
ANDA #208971		 ORIG-1 CINACALCET HYDROCHLORIDE ZYDUS PHARMS USA INC Tentative Approval
11/26/2018 SODIUM NITROPRUSSIDE
ANDA #210467		 ORIG-1 SODIUM NITROPRUSSIDE SUN PHARM Approval
11/26/2018 VITRAKVI
NDA #210861		 ORIG-1 LAROTRECTINIB SULFATE BAYER HLTHCARE Type 1 - New Molecular Entity Approval
11/26/2018 VITRAKVI
NDA #211710		 ORIG-1 LAROTRECTINIB SULFATE BAYER HEALTHCARE Type 3 - New Dosage Form Approval
11/27/2018 ISTODAX
NDA #022393		 SUPPL-15 ROMIDEPSIN BRISTOL-MYERS Labeling Approval
11/27/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #091298		 SUPPL-7 PIOGLITAZONE HYDROCHLORIDE TORRENT PHARMS LTD Labeling Approval
11/27/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #091298		 SUPPL-9 PIOGLITAZONE HYDROCHLORIDE TORRENT PHARMS LTD Labeling Approval
11/27/2018 LANSOPRAZOLE
ANDA #200816		 ORIG-1 LANSOPRAZOLE ZYDUS PHARMS Approval
11/27/2018 OXYCODONE AND ACETAMINOPHEN
ANDA #202142		 ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE MIKART Approval
11/27/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #206569		 ORIG-1 TENOFOVIR DISOPROXIL FUMARATE MYLAN Approval
11/27/2018 AMINOCAPROIC ACID
ANDA #209060		 ORIG-1 AMINOCAPROIC ACID SUNNY Approval
11/27/2018 ARGATROBAN IN SODIUM CHLORIDE
NDA #209552		 ORIG-1 ARGATROBAN EUGIA PHARMA SPECLTS Type 5 - New Formulation or New Manufacturer Approval
11/28/2018 REGRANEX
BLA #103691		 SUPPL-5134 BECAPLERMIN SMITH AND NEPHEW Approval
11/28/2018 CAMPATH
BLA #103948		 SUPPL-5160 ALEMTUZUMAB GENZYME Approval
11/28/2018 CAMPATH
BLA #103948		 SUPPL-5165 ALEMTUZUMAB GENZYME Approval
11/28/2018 LEMTRADA
BLA #103948		 SUPPL-5160 ALEMTUZUMAB GENZYME Approval
11/28/2018 LEMTRADA
BLA #103948		 SUPPL-5165 ALEMTUZUMAB GENZYME Approval
11/28/2018 LANSOPRAZOLE
ANDA #202396		 ORIG-1 LANSOPRAZOLE MYLAN Approval
11/28/2018 VRAYLAR
NDA #204370		 SUPPL-5 CARIPRAZINE HYDROCHLORIDE ABBVIE Labeling Approval
11/28/2018 FIRDAPSE
NDA #208078		 ORIG-1 AMIFAMPRIDINE PHOSPHATE CATALYST PHARMS Type 1 - New Molecular Entity Approval
11/28/2018 GLYCOPYRROLATE
ANDA #210244		 ORIG-1 GLYCOPYRROLATE EUGIA PHARMA Approval
11/28/2018 XOSPATA
NDA #211349		 ORIG-1 GILTERITINIB FUMARATE ASTELLAS Type 1 - New Molecular Entity Approval
11/28/2018 TRUXIMA
BLA #761088		 ORIG-1 RITUXIMAB-ABBS CELLTRION INC Approval
11/29/2018 CHILDREN'S MOTRIN
NDA #020516		 SUPPL-36 IBUPROFEN J AND J CONSUMER INC Labeling Approval
11/29/2018 SEROQUEL
NDA #020639		 SUPPL-60 QUETIAPINE FUMARATE ASTRAZENECA Labeling Approval
11/29/2018 SEROQUEL
NDA #020639		 SUPPL-63 QUETIAPINE FUMARATE ASTRAZENECA Labeling Approval
11/29/2018 LANTUS
BLA #021081		 SUPPL-71 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
11/29/2018 LANTUS SOLOSTAR
BLA #021081		 SUPPL-71 INSULIN GLARGINE RECOMBINANT SANOFI AVENTIS US Approval
11/29/2018 NEUPRO
NDA #021829		 SUPPL-15 ROTIGOTINE UCB INC Labeling Approval
11/29/2018 ARRANON
NDA #021877		 SUPPL-9 NELARABINE SANDOZ Labeling Approval
11/29/2018 OSMOPREP
NDA #021892		 SUPPL-14 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SALIX PHARMS Labeling Approval
11/29/2018 NAPROXEN SODIUM
NDA #021920		 SUPPL-22 NAPROXEN SODIUM BIONPHARMA Labeling Approval
11/29/2018 SEROQUEL XR
NDA #022047		 SUPPL-33 QUETIAPINE FUMARATE ASTRAZENECA Labeling Approval
11/29/2018 SEROQUEL XR
NDA #022047		 SUPPL-37 QUETIAPINE FUMARATE ASTRAZENECA Labeling Approval
11/29/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #076801		 SUPPL-4 PIOGLITAZONE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
11/29/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #076801		 SUPPL-6 PIOGLITAZONE HYDROCHLORIDE MYLAN PHARMS INC Labeling Approval
11/29/2018 HERCEPTIN
BLA #103792		 SUPPL-5345 TRASTUZUMAB GENENTECH Approval
11/29/2018 CAMPATH
BLA #103948		 SUPPL-5167 ALEMTUZUMAB GENZYME Approval
11/29/2018 LEMTRADA
BLA #103948		 SUPPL-5167 ALEMTUZUMAB GENZYME Approval
11/29/2018 ASTAGRAF XL
NDA #204096		 SUPPL-5 TACROLIMUS ASTELLAS Efficacy Approval
11/29/2018 SEVELAMER CARBONATE
ANDA #204451		 ORIG-1 SEVELAMER CARBONATE RISING Approval
11/29/2018 OXCARBAZEPINE
ANDA #206576		 ORIG-1 OXCARBAZEPINE TWI PHARMS INC Tentative Approval
11/29/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #206738		 SUPPL-1 PIOGLITAZONE HYDROCHLORIDE PURACAP PHARM LLC Labeling Approval
11/29/2018 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #208129		 ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE FRESENIUS KABI USA Approval
11/29/2018 COLCHICINE
ANDA #208678		 ORIG-1 COLCHICINE PAR PHARM INC Approval
11/29/2018 FLUOCINONIDE
ANDA #209699		 ORIG-1 FLUOCINONIDE ENCUBE ETHICALS Approval
11/30/2018 HIBICLENS
NDA #017768		 SUPPL-49 CHLORHEXIDINE GLUCONATE MOLNLYCKE HLTH Labeling Approval
11/30/2018 NIZORAL ANTI-DANDRUFF
NDA #020310		 SUPPL-22 KETOCONAZOLE KRAMER Manufacturing (CMC) Approval
11/30/2018 LETAIRIS
NDA #022081		 SUPPL-40 AMBRISENTAN GILEAD Labeling Approval
11/30/2018 NATEGLINIDE
ANDA #077461		 SUPPL-3 NATEGLINIDE DR REDDYS LABS LTD Labeling Approval
11/30/2018 NATEGLINIDE
ANDA #077461		 SUPPL-4 NATEGLINIDE DR REDDYS LABS LTD Labeling Approval
11/30/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #200268		 SUPPL-6 PIOGLITAZONE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
11/30/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #200268		 SUPPL-7 PIOGLITAZONE HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
11/30/2018 RABEPRAZOLE SODIUM
ANDA #202376		 SUPPL-8 RABEPRAZOLE SODIUM TORRENT Labeling Approval
11/30/2018 RABEPRAZOLE SODIUM
ANDA #202376		 SUPPL-10 RABEPRAZOLE SODIUM TORRENT Labeling Approval
11/30/2018 RABEPRAZOLE SODIUM
ANDA #202376		 SUPPL-13 RABEPRAZOLE SODIUM TORRENT Labeling Approval
11/30/2018 RABEPRAZOLE SODIUM
ANDA #202376		 SUPPL-14 RABEPRAZOLE SODIUM TORRENT Labeling Approval
11/30/2018 XALKORI
NDA #202570		 SUPPL-26 CRIZOTINIB PF PRISM CV Efficacy Approval
11/30/2018 BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
ANDA #202584		 ORIG-1 BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE NOSTRUM LABS INC Approval
11/30/2018 GLYCOPYRROLATE
ANDA #203657		 ORIG-1 GLYCOPYRROLATE ALEMBIC Approval
11/30/2018 PIOGLITAZONE HYDROCHLORIDE
ANDA #204133		 SUPPL-2 PIOGLITAZONE HYDROCHLORIDE ANNORA PHARMA Labeling Approval
11/30/2018 FYREMADEL
ANDA #204246		 ORIG-1 GANIRELIX ACETATE SUN PHARM Approval
11/30/2018 DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #205723		 SUPPL-1 DIPHENHYDRAMINE HYDROCHLORIDE MICRO LABS Manufacturing (CMC) Approval
11/30/2018 LAMOTRIGINE
ANDA #207497		 ORIG-1 LAMOTRIGINE AMNEAL PHARMS Approval
11/30/2018 ARISTADA
NDA #207533		 SUPPL-13 ARIPIPRAZOLE LAUROXIL ALKERMES INC Labeling Approval
11/30/2018 SERNIVO
NDA #208079		 SUPPL-1 BETAMETHASONE DIPROPIONATE PRIMUS PHARMS Labeling Approval
11/30/2018 DEXTENZA
NDA #208742		 ORIG-1 DEXAMETHASONE OCULAR THERAPEUTIX Type 3 - New Dosage Form Approval
11/30/2018 TERIFLUNOMIDE
ANDA #209668		 ORIG-1 TERIFLUNOMIDE ZYDUS PHARMS Approval
11/30/2018 ETODOLAC
ANDA #209888		 ORIG-1 ETODOLAC EDENBRIDGE PHARMS Approval
11/30/2018 METHYLPHENIDATE HYDROCHLORIDE
ANDA #210818		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ALVOGEN Approval
11/30/2018 VORICONAZOLE
ANDA #211661		 ORIG-1 VORICONAZOLE SLATE RUN PHARMA Approval
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