U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

All Approvals and Tentative Approvals
June 2017

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 09, 2024.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
06/01/2017 SAMSCA
NDA #022275		 SUPPL-15 TOLVAPTAN OTSUKA Labeling Approval
06/01/2017 CEFPROZIL
ANDA #065327		 SUPPL-1 CEFPROZIL APOTEX INC Labeling Approval
06/01/2017 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #070765		 SUPPL-23 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE ANDA REPOSITORY Labeling Approval
06/01/2017 CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #070766		 SUPPL-19 AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE ANDA REPOSITORY Labeling Approval
06/01/2017 BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ANDA #075618		 SUPPL-25 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE HIKMA INTL PHARMS Labeling Approval
06/01/2017 FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #076236		 SUPPL-8 FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE BARR Manufacturing (CMC) Tentative Approval
06/01/2017 OXYCODONE HYDROCHLORIDE
ANDA #090895		 SUPPL-8 OXYCODONE HYDROCHLORIDE EPIC PHARMA LLC Labeling Approval
06/01/2017 OXYCODONE HYDROCHLORIDE
ANDA #091313		 SUPPL-5 OXYCODONE HYDROCHLORIDE DR REDDYS LABS SA Labeling Approval
06/01/2017 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #201013		 SUPPL-7 ACETAMINOPHEN; HYDROCODONE BITARTRATE AUROLIFE PHARMA LLC Labeling Approval
06/01/2017 LANSOPRAZOLE
ANDA #202176		 SUPPL-3 LANSOPRAZOLE WOCKHARDT Labeling Approval
06/01/2017 LANSOPRAZOLE
ANDA #202176		 SUPPL-6 LANSOPRAZOLE WOCKHARDT Labeling Approval
06/01/2017 MIRTAZAPINE
ANDA #205798		 ORIG-1 MIRTAZAPINE SQUARE PHARMS Approval
06/01/2017 LEVOFLOXACIN
ANDA #205968		 ORIG-1 LEVOFLOXACIN ZYDUS PHARMS Approval
06/02/2017 NADOLOL
ANDA #208832		 ORIG-1 NADOLOL AMNEAL PHARMS CO Approval
06/05/2017 MESALAMINE
ANDA #091640		 ORIG-1 MESALAMINE ZYDUS PHARMS Approval
06/05/2017 NPLATE
BLA #125268		 SUPPL-160 ROMIPLOSTIM AMGEN Approval
06/05/2017 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
ANDA #203460		 SUPPL-5 MIDAZOLAM HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
06/05/2017 MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
ANDA #203460		 SUPPL-6 MIDAZOLAM HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
06/05/2017 CYANOCOBALAMIN
ANDA #204829		 ORIG-1 CYANOCOBALAMIN MYLAN LABS LTD Approval
06/05/2017 LITHIUM CARBONATE
ANDA #205663		 ORIG-1 LITHIUM CARBONATE UNIQUE Approval
06/05/2017 ENTACAPONE
ANDA #207210		 ORIG-1 ENTACAPONE MACLEODS PHARMS LTD Approval
06/05/2017 ARISTADA
NDA #207533		 SUPPL-4 ARIPIPRAZOLE LAUROXIL ALKERMES INC Efficacy Approval
06/05/2017 BUTALBITAL AND ACETAMINOPHEN
ANDA #207635		 ORIG-1 ACETAMINOPHEN; BUTALBITAL ALVOGEN Approval
06/05/2017 DESOGESTREL AND ETHINYL ESTRADIOL
ANDA #209170		 ORIG-1 DESOGESTREL; ETHINYL ESTRADIOL NAARI PTE LTD Approval
06/06/2017 HUMALOG
BLA #020563		 SUPPL-176 INSULIN LISPRO RECOMBINANT LILLY Approval
06/06/2017 HUMALOG KWIKPEN
BLA #020563		 SUPPL-176 INSULIN LISPRO RECOMBINANT LILLY Approval
06/06/2017 HUMALOG PEN
BLA #020563		 SUPPL-176 INSULIN LISPRO RECOMBINANT LILLY Approval
06/06/2017 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-176 INSULIN LISPRO RECOMBINANT LILLY Approval
06/06/2017 LEFLUNOMIDE
ANDA #077087		 SUPPL-13 LEFLUNOMIDE WANBANG BIOPHARMS Labeling Approval
06/06/2017 HUMALOG KWIKPEN
BLA #205747		 SUPPL-10 INSULIN LISPRO RECOMBINANT ELI LILLY AND CO Approval
06/06/2017 GLEOLAN
NDA #208630		 ORIG-1 AMINOLEVULINIC ACID HYDROCHLORIDE NXDC Type 3 - New Dosage Form Approval
06/07/2017 NORVIR
NDA #020659		 SUPPL-67 RITONAVIR ABBVIE Labeling Approval
06/07/2017 NORVIR
NDA #022417		 SUPPL-19 RITONAVIR ABBVIE Labeling Approval
06/07/2017 DUEXIS
NDA #022519		 SUPPL-11 FAMOTIDINE; IBUPROFEN HORIZON Labeling Approval
06/07/2017 ORENITRAM
NDA #203496		 SUPPL-7 TREPROSTINIL DIOLAMINE UNITED THERAP Labeling Approval
06/07/2017 BEPOTASTINE BESILATE
ANDA #206080		 ORIG-1 BEPOTASTINE BESILATE SANDOZ INC Tentative Approval
06/07/2017 AMANTADINE HYDROCHLORIDE
ANDA #209047		 ORIG-1 AMANTADINE HYDROCHLORIDE STRIDES PHARMA Approval
06/07/2017 NORVIR
NDA #209512		 ORIG-1 RITONAVIR ABBVIE Type 3 - New Dosage Form Approval
06/08/2017 LO/OVRAL-28
NDA #017802		 SUPPL-29 ETHINYL ESTRADIOL; NORGESTREL WYETH PHARMS Labeling Approval
06/08/2017 MIRENA
NDA #021225		 SUPPL-38 LEVONORGESTREL BAYER HLTHCARE Efficacy Approval
06/08/2017 TRUVADA
NDA #021752		 SUPPL-52 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD REMS Approval
06/08/2017 CLONIDINE HYDROCHLORIDE
ANDA #071785		 SUPPL-19 CLONIDINE HYDROCHLORIDE CHARTWELL MOLECULES Labeling Approval
06/08/2017 GABAPENTIN
ANDA #076403		 SUPPL-2 GABAPENTIN ACELLA PHARMS LLC Labeling Approval
06/08/2017 SCANDONEST PLAIN
ANDA #088387		 SUPPL-35 MEPIVACAINE HYDROCHLORIDE DEPROCO Manufacturing (CMC) Approval
06/08/2017 IRBESARTAN AND HYDROCHLOROTHIAZIDE
ANDA #090351		 ORIG-2 HYDROCHLOROTHIAZIDE; IRBESARTAN HIKMA Approval
06/08/2017 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #090894		 ORIG-1 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TEVA PHARMS USA Approval
06/08/2017 DILTIAZEM HYDROCHLORIDE
ANDA #203023		 ORIG-1 DILTIAZEM HYDROCHLORIDE SUN PHARM Approval
06/08/2017 NYSTATIN
ANDA #208581		 ORIG-1 NYSTATIN ZYDUS PHARMS Approval
06/08/2017 CIGENSA NORETHINDRONE ACETATE;ETHINYL ESTRADIOL; ETHINYL ESTRADIOL;FERROUS FUMARATE
ANDA #209014		 ORIG-1 CIGENSA NORETHINDRONE ACETATE;ETHINYL ESTRADIOL; ETHINYL ESTRADIOL;FERROUS FUMARATE AUROBINDO PHARMA LTD Tentative Approval
06/08/2017 SILIQ
BLA #761032		 SUPPL-1 BRODALUMAB VALEANT LUXEMBOURG Approval
06/09/2017 CUBICIN
NDA #021572		 SUPPL-59 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
06/09/2017 CUBICIN RF
NDA #021572		 SUPPL-59 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
06/09/2017 VELCADE
NDA #021602		 SUPPL-43 BORTEZOMIB TAKEDA PHARMS USA Labeling Approval
06/09/2017 BIAXIN
NDA #050662		 SUPPL-58 CLARITHROMYCIN ABBVIE Labeling Approval
06/09/2017 BIAXIN
NDA #050698		 SUPPL-38 CLARITHROMYCIN ABBVIE Labeling Approval
06/09/2017 BIAXIN XL
NDA #050775		 SUPPL-26 CLARITHROMYCIN ABBVIE Labeling Approval
06/09/2017 MEGESTROL ACETATE
ANDA #203960		 ORIG-1 MEGESTROL ACETATE HIKMA Approval
06/09/2017 MEMANTINE HYDROCHLORIDE
ANDA #205784		 ORIG-1 MEMANTINE HYDROCHLORIDE ANCHEN PHARMS Approval
06/09/2017 HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE
ANDA #206891		 ORIG-1 CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE ACELLA Approval
06/09/2017 SPRITAM
NDA #207958		 SUPPL-4 LEVETIRACETAM APRECIA PHARMS Labeling Approval
06/09/2017 PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #209008		 ORIG-1 PSEUDOEPHEDRINE HYDROCHLORIDE AUROBINDO PHARMA Approval
06/09/2017 AMANTADINE HYDROCHLORIDE
ANDA #209035		 ORIG-1 AMANTADINE HYDROCHLORIDE STRIDES PHARMA Approval
06/12/2017 BUPROPION HYDROCHLORIDE
ANDA #077285		 SUPPL-34 BUPROPION HYDROCHLORIDE WATSON LABS INC Labeling Approval
06/12/2017 EZETIMIBE
ANDA #078724		 ORIG-1 EZETIMIBE TEVA PHARMS USA Approval
06/12/2017 BUPROPION HYDROCHLORIDE
ANDA #090325		 SUPPL-13 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
06/12/2017 BUPROPION HYDROCHLORIDE
ANDA #090942		 SUPPL-12 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
06/12/2017 BUPROPION HYDROCHLORIDE
ANDA #090942		 SUPPL-13 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
06/12/2017 INTRON A
BLA #103132		 SUPPL-5195 INTERFERON ALFA-2B SCHERING Approval
06/12/2017 EZETIMIBE
ANDA #200831		 ORIG-1 EZETIMIBE WATSON LABS INC Approval
06/12/2017 ADVIL
NDA #201803		 SUPPL-8 IBUPROFEN SODIUM HALEON US HOLDINGS Labeling Approval
06/12/2017 LEVETIRACETAM IN SODIUM CHLORIDE
NDA #202543		 SUPPL-10 LEVETIRACETAM HQ SPCLT PHARMA Labeling Approval
06/12/2017 EZETIMIBE
ANDA #203931		 ORIG-1 EZETIMIBE SANDOZ Approval
06/12/2017 OXYCODONE HYDROCHLORIDE
ANDA #204021		 ORIG-1 OXYCODONE HYDROCHLORIDE NOVEL LABS INC Approval
06/12/2017 EZETIMIBE
ANDA #204331		 ORIG-1 EZETIMIBE ZYDUS PHARMS Approval
06/12/2017 BUPROPION HYDROCHLORIDE
ANDA #206556		 SUPPL-3 BUPROPION HYDROCHLORIDE INVAGEN PHARMS Labeling Approval
06/12/2017 BENDAMUSTINE HYDROCHLORIDE
ANDA #207149		 ORIG-1 BENDAMUSTINE HYDROCHLORIDE WOCKHARDT USA Tentative Approval
06/12/2017 EZETIMIBE
ANDA #207311		 ORIG-1 EZETIMIBE OHM LABS INC Approval
06/12/2017 EZETIMIBE
ANDA #208332		 ORIG-1 EZETIMIBE APOTEX Approval
06/12/2017 ITRACONAZOLE
ANDA #208591		 ORIG-1 ITRACONAZOLE ALKEM LABS LTD Approval
06/12/2017 EZETIMIBE
ANDA #208803		 ORIG-1 EZETIMIBE AMNEAL PHARMS CO Approval
06/12/2017 AMANTADINE HYDROCHLORIDE
ANDA #209171		 ORIG-1 AMANTADINE HYDROCHLORIDE HERITAGE PHARMA Approval
06/13/2017 VERMOX
NDA #017481		 SUPPL-47 MEBENDAZOLE JANSSEN PHARMS Labeling Approval
06/13/2017 SULAR
NDA #020356		 SUPPL-27 NISOLDIPINE COVIS Labeling Approval
06/13/2017 ZIDOVUDINE
ANDA #077981		 SUPPL-24 ZIDOVUDINE CIPLA LTD Labeling Approval
06/13/2017 ZIDOVUDINE
ANDA #077981		 SUPPL-25 ZIDOVUDINE CIPLA LTD Labeling Approval
06/13/2017 OMEPRAZOLE
ANDA #204661		 ORIG-1 OMEPRAZOLE TEVA PHARMS USA Approval
06/13/2017 INCRUSE ELLIPTA
NDA #205382		 SUPPL-6 UMECLIDINIUM BROMIDE GLAXO GRP ENGLAND Labeling Approval
06/13/2017 ACYCLOVIR SODIUM
ANDA #206606		 ORIG-1 ACYCLOVIR SODIUM ZYDUS PHARMS Approval
06/13/2017 SEVELAMER CARBONATE
ANDA #207624		 ORIG-1 SEVELAMER CARBONATE AUROBINDO PHARMA Approval
06/14/2017 DYSPORT
BLA #125274		 SUPPL-109 abobotulinumtoxinA IPSEN BIOPHARM LTD Approval
06/14/2017 CALCITRIOL
ANDA #203289		 ORIG-1 CALCITRIOL AMNEAL PHARMS Approval
06/14/2017 PREZCOBIX
NDA #205395		 SUPPL-4 COBICISTAT; DARUNAVIR JANSSEN PRODS Labeling Approval
06/14/2017 DOXYCYCLINE HYCLATE
ANDA #208765		 ORIG-1 DOXYCYCLINE HYCLATE DR REDDYS LABS SA Approval
06/15/2017 ZOLOFT
NDA #019839		 SUPPL-88 SERTRALINE HYDROCHLORIDE VIATRIS Labeling Approval
06/15/2017 ZOLOFT
NDA #020990		 SUPPL-46 SERTRALINE HYDROCHLORIDE VIATRIS Labeling Approval
06/15/2017 KALETRA
NDA #021226		 SUPPL-45 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
06/15/2017 KALETRA
NDA #021251		 SUPPL-54 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
06/15/2017 VFEND
NDA #021266		 SUPPL-41 VORICONAZOLE PF PRISM CV Labeling Approval
06/15/2017 VFEND
NDA #021267		 SUPPL-53 VORICONAZOLE PF PRISM CV Labeling Approval
06/15/2017 VFEND
NDA #021630		 SUPPL-31 VORICONAZOLE PF PRISM CV Labeling Approval
06/15/2017 KALETRA
NDA #021906		 SUPPL-49 LOPINAVIR; RITONAVIR ABBVIE Labeling Approval
06/15/2017 INVEGA SUSTENNA
NDA #022264		 SUPPL-23 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
06/15/2017 METAXALONE
ANDA #203695		 ORIG-1 METAXALONE ACTAVIS LABS FL INC Approval
06/15/2017 AUROVELA 24 FE
ANDA #207504		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE AUROBINDO PHARMA Approval
06/15/2017 SYMJEPI
NDA #207534		 ORIG-1 EPINEPHRINE ADAMIS PHARMS CORP Type 5 - New Formulation or New Manufacturer Approval
06/15/2017 AUROVELA FE 1.5/30
ANDA #207580		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE AUROBINDO PHARMA Approval
06/15/2017 CALCIUM GLUCONATE
NDA #208418		 ORIG-1 CALCIUM GLUCONATE FRESENIUS KABI USA Type 7 - Drug Already Marketed without Approved NDA Approval
06/15/2017 CALCIUM GLUCONATE IN SODIUM CHLORIDE
NDA #208418		 ORIG-1 CALCIUM GLUCONATE FRESENIUS KABI USA Type 7 - Drug Already Marketed without Approved NDA Approval
06/15/2017 GLYCOPYRROLATE
ANDA #208973		 ORIG-1 GLYCOPYRROLATE AMNEAL Approval
06/15/2017 AMANTADINE HYDROCHLORIDE
ANDA #209221		 ORIG-1 AMANTADINE HYDROCHLORIDE CHARTWELL MOLECULAR Approval
06/16/2017 ADDYI
NDA #022526		 SUPPL-4 FLIBANSERIN SPROUT PHARMS REMS Approval
06/16/2017 SYNERCID
NDA #050747		 SUPPL-15 QUINUPRISTIN; DALFOPRISTIN KING PHARMS Labeling Approval
06/16/2017 SYNERCID
NDA #050748		 SUPPL-14 DALFOPRISTIN; QUINUPRISTIN KING PHARMS Labeling Approval
06/16/2017 PROPRANOLOL HYDROCHLORIDE
ANDA #070690		 SUPPL-21 PROPRANOLOL HYDROCHLORIDE HIKMA Labeling Approval
06/16/2017 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #076914		 SUPPL-4 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE GRAVITI PHARMS Labeling Approval
06/16/2017 LAMOTRIGINE
ANDA #078947		 SUPPL-22 LAMOTRIGINE TORRENT PHARMS Labeling Approval
06/16/2017 LAMOTRIGINE
ANDA #078947		 SUPPL-23 LAMOTRIGINE TORRENT PHARMS Labeling Approval
06/16/2017 OXYCODONE AND ACETAMINOPHEN
ANDA #201972		 SUPPL-7 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE AUROLIFE PHARMA LLC Labeling Approval
06/16/2017 SKLICE
NDA #202736		 SUPPL-3 IVERMECTIN ARBOR PHARMS LLC Labeling Approval
06/16/2017 TAFINLAR
NDA #202806		 SUPPL-7 DABRAFENIB MESYLATE NOVARTIS Labeling Approval
06/16/2017 DIFLUNISAL
ANDA #203547		 ORIG-1 DIFLUNISAL ZYDUS PHARMS Approval
06/16/2017 NIACIN
ANDA #203899		 ORIG-1 NIACIN LANNETT CO INC Approval
06/16/2017 NEURACEQ
NDA #204677		 SUPPL-14 FLORBETABEN F-18 LIFE MOLECULAR Labeling Approval
06/16/2017 OLANZAPINE
ANDA #204866		 ORIG-1 OLANZAPINE HIKMA Approval
06/16/2017 CISATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #205872		 ORIG-1 CISATRACURIUM BESYLATE ACCORD HLTHCARE Approval
06/16/2017 CISATRACURIUM BESYLATE
ANDA #205873		 ORIG-1 CISATRACURIUM BESYLATE ACCORD HLTHCARE Approval
06/16/2017 FELBAMATE
ANDA #206314		 ORIG-1 FELBAMATE TARO Approval
06/16/2017 ORFADIN
NDA #206356		 SUPPL-4 NITISINONE SWEDISH ORPHAN Labeling Approval
06/16/2017 ELETRIPTAN HYDROBROMIDE
ANDA #206409		 ORIG-1 ELETRIPTAN HYDROBROMIDE ZYDUS PHARMS Approval
06/16/2017 XADAGO
NDA #207145		 SUPPL-1 SAFINAMIDE MESYLATE MDD US Labeling Approval
06/16/2017 AUROVELA FE 1/20
ANDA #207505		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE AUROBINDO PHARMA Approval
06/16/2017 AUROVELA 1/20
ANDA #207506		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE AUROBINDO PHARMA Approval
06/16/2017 TESTOSTERONE CYPIONATE
ANDA #207742		 ORIG-1 TESTOSTERONE CYPIONATE AM REGENT Approval
06/16/2017 HER STYLE
ANDA #207976		 SUPPL-1 LEVONORGESTREL NOVAST LABS Labeling Approval
06/16/2017 HER STYLE
ANDA #207976		 SUPPL-2 LEVONORGESTREL NOVAST LABS Labeling Approval
06/16/2017 LINAGLIPTIN
ANDA #208415		 ORIG-1 LINAGLIPTIN AUROBINDO PHARMA LTD Tentative Approval
06/16/2017 DARZALEX
BLA #761036		 SUPPL-5 DARATUMUMAB JANSSEN BIOTECH Approval
06/17/2017 ABSORICA
NDA #021951		 SUPPL-10 ISOTRETINOIN SUN PHARM INDS INC REMS Approval
06/17/2017 AMNESTEEM
ANDA #075945		 SUPPL-34 ISOTRETINOIN MYLAN PHARMS INC REMS Approval
06/17/2017 CLARAVIS
ANDA #076135		 SUPPL-38 ISOTRETINOIN TEVA PHARMS USA REMS Approval
06/17/2017 CLARAVIS
ANDA #076356		 SUPPL-35 ISOTRETINOIN TEVA PHARMS USA REMS Approval
06/17/2017 MYORISAN
ANDA #076485		 SUPPL-15 ISOTRETINOIN UPSHER SMITH LABS REMS Approval
06/17/2017 ZENATANE
ANDA #202099		 SUPPL-9 ISOTRETINOIN DR REDDYS LABS LTD REMS Approval
06/19/2017 PREZISTA
NDA #021976		 SUPPL-45 DARUNAVIR JANSSEN PRODS Labeling Approval
06/19/2017 TOTECT
NDA #022025		 SUPPL-15 DEXRAZOXANE HYDROCHLORIDE CLINIGEN Manufacturing (CMC) Approval
06/19/2017 TACLONEX
NDA #022185		 SUPPL-25 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE LEO PHARMA AS Manufacturing (CMC) Approval
06/19/2017 TACLONEX
NDA #022185		 SUPPL-25 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE LEO PHARMA AS Manufacturing (CMC) Approval
06/19/2017 PREZISTA
NDA #202895		 SUPPL-20 DARUNAVIR JANSSEN PRODS Labeling Approval
06/19/2017 DANTROLENE SODIUM
ANDA #204762		 ORIG-1 DANTROLENE SODIUM HIKMA Approval
06/19/2017 COTEMPLA XR-ODT
NDA #205489		 ORIG-1 METHYLPHENIDATE NEOS THERAPS INC Type 3 - New Dosage Form Approval
06/19/2017 BAXDELA
NDA #208610		 ORIG-1 DELAFLOXACIN MEGLUMINE MELINTA Type 1 - New Molecular Entity Approval
06/19/2017 BAXDELA
NDA #208611		 ORIG-1 DELAFLOXACIN MEGLUMINE MELINTA Type 3 - New Dosage Form Approval
06/20/2017 MYDAYIS
NDA #022063		 ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Type 3 - New Dosage Form Approval
06/20/2017 ACETAZOLAMIDE SODIUM
ANDA #205358		 ORIG-1 ACETAZOLAMIDE SODIUM PAR STERILE PRODUCTS Approval
06/20/2017 PIROXICAM
ANDA #206136		 ORIG-1 PIROXICAM STRIDES PHARMA Approval
06/20/2017 LIDOCAINE
ANDA #206297		 SUPPL-2 LIDOCAINE AMNEAL PHARMS Labeling Approval
06/20/2017 LIDOCAINE
ANDA #206297		 SUPPL-3 LIDOCAINE AMNEAL PHARMS Manufacturing (CMC) Approval
06/20/2017 LIDOCAINE
ANDA #206297		 SUPPL-5 LIDOCAINE AMNEAL PHARMS Manufacturing (CMC) Approval
06/20/2017 PAROXETINE MESYLATE
ANDA #207139		 ORIG-1 PAROXETINE MESYLATE ACTAVIS LABS FL INC Approval
06/20/2017 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #207171		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE LANNETT CO INC Approval
06/20/2017 METRONIDAZOLE
ANDA #208681		 ORIG-1 METRONIDAZOLE ALEMBIC Approval
06/20/2017 CANDESARTAN CILEXETIL
ANDA #209119		 ORIG-1 CANDESARTAN CILEXETIL ALEMBIC Approval
06/21/2017 DARAPRIM
NDA #008578		 SUPPL-20 PYRIMETHAMINE TILDE SCIENCES Labeling Approval
06/21/2017 CHILDREN'S ADVIL
NDA #020589		 SUPPL-35 IBUPROFEN HALEON US HOLDINGS Labeling Approval
06/21/2017 CHILDREN'S ADVIL-FLAVORED
NDA #020589		 SUPPL-35 IBUPROFEN HALEON US HOLDINGS Labeling Approval
06/21/2017 ESTRACE
ANDA #086069		 SUPPL-23 ESTRADIOL ALLERGAN Labeling Approval
06/21/2017 GRANIX
BLA #125294		 SUPPL-42 TBO-FILGRASTIM SICOR BIOTECH Approval
06/21/2017 SYNRIBO
NDA #203585		 SUPPL-5 OMACETAXINE MEPESUCCINATE TEVA PHARMS INTL Labeling Approval
06/21/2017 IMATINIB MESYLATE
ANDA #204644		 ORIG-1 IMATINIB MESYLATE MYLAN Approval
06/21/2017 AMANTADINE HYDROCHLORIDE
ANDA #208966		 ORIG-1 AMANTADINE HYDROCHLORIDE ALEMBIC Approval
06/21/2017 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #209036		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE ABHAI LLC Approval
06/21/2017 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #209037		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE ABHAI LLC Approval
06/22/2017 PRIMAQUINE
NDA #008316		 SUPPL-23 PRIMAQUINE PHOSPHATE SANOFI AVENTIS US Labeling Approval
06/22/2017 VALCYTE
NDA #021304		 SUPPL-12 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Labeling Approval
06/22/2017 VALCYTE
NDA #022257		 SUPPL-7 VALGANCICLOVIR HYDROCHLORIDE CHEPLAPHARM Labeling Approval
06/22/2017 QUETIAPINE FUMARATE
ANDA #077745		 SUPPL-9 QUETIAPINE FUMARATE TEVA PHARMS Labeling Approval
06/22/2017 QUETIAPINE FUMARATE
ANDA #077745		 SUPPL-10 QUETIAPINE FUMARATE TEVA PHARMS Labeling Approval
06/22/2017 QUETIAPINE FUMARATE
ANDA #090749		 SUPPL-5 QUETIAPINE FUMARATE HIKMA Labeling Approval
06/22/2017 QUETIAPINE FUMARATE
ANDA #090749		 SUPPL-6 QUETIAPINE FUMARATE HIKMA Labeling Approval
06/22/2017 QUETIAPINE FUMARATE
ANDA #090960		 SUPPL-8 QUETIAPINE FUMARATE ZENNOVA Labeling Approval
06/22/2017 QUETIAPINE FUMARATE
ANDA #090960		 SUPPL-9 QUETIAPINE FUMARATE ZENNOVA Labeling Approval
06/22/2017 SIMPONI
BLA #125289		 SUPPL-133 GOLIMUMAB CENTOCOR ORTHO BIOTECH INC Approval
06/22/2017 TAFINLAR
NDA #202806		 SUPPL-6 DABRAFENIB MESYLATE NOVARTIS Efficacy Approval
06/22/2017 INDOMETHACIN
ANDA #203501		 ORIG-1 INDOMETHACIN GLENMARK PHARMS LTD Approval
06/22/2017 MEKINIST
NDA #204114		 SUPPL-5 TRAMETINIB DIMETHYL SULFOXIDE NOVARTIS Efficacy Approval
06/22/2017 ATRACURIUM BESYLATE
ANDA #206096		 ORIG-1 ATRACURIUM BESYLATE MYLAN LABS LTD Approval
06/22/2017 MORPHINE SULFATE
ANDA #206308		 ORIG-1 MORPHINE SULFATE RHODES PHARMS Approval
06/22/2017 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #207172		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE LANNETT CO INC Approval
06/22/2017 METHOCARBAMOL
ANDA #207496		 ORIG-1 METHOCARBAMOL AM REGENT Approval
06/22/2017 AMANTADINE HYDROCHLORIDE
ANDA #208107		 SUPPL-2 AMANTADINE HYDROCHLORIDE WATSON LABS INC Manufacturing (CMC) Approval
06/22/2017 RITUXAN HYCELA
BLA #761064		 ORIG-1 RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) GENENTECH INC Approval
06/22/2017 RITUXAN HYCELA
BLA #761064		 SUPPL-1 RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) GENENTECH INC Approval
06/23/2017 ANECTINE
NDA #008453		 SUPPL-33 SUCCINYLCHOLINE CHLORIDE SANDOZ Manufacturing (CMC) Approval
06/23/2017 LIPITOR
NDA #020702		 SUPPL-67 ATORVASTATIN CALCIUM UPJOHN Efficacy Approval
06/23/2017 LIPITOR
NDA #020702		 SUPPL-69 ATORVASTATIN CALCIUM UPJOHN Labeling Approval
06/23/2017 AEROSPAN HFA
NDA #021247		 SUPPL-15 FLUNISOLIDE MYLAN SPECIALITY LP Labeling Approval
06/23/2017 CADUET
NDA #021540		 SUPPL-39 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM PHARMACIA Labeling Approval
06/23/2017 ENTECAVIR
ANDA #206745		 ORIG-1 ENTECAVIR ZYDUS PHARMS Approval
06/23/2017 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #206869		 ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE AMNEAL PHARMS NY Approval
06/23/2017 AZACITIDINE
ANDA #207234		 ORIG-1 AZACITIDINE NATCO PHARMA LTD Approval
06/23/2017 GLYCOPYRROLATE
ANDA #207639		 ORIG-1 GLYCOPYRROLATE SOMERSET THERAPS LLC Approval
06/23/2017 BEVYXXA
NDA #208383		 ORIG-1 BETRIXABAN PORTOLA PHARMS INC Type 1 - New Molecular Entity Approval
06/23/2017 IBUPROFEN
ANDA #209204		 ORIG-1 IBUPROFEN TARO Approval
06/26/2017 OXYBUTYNIN CHLORIDE
ANDA #202332		 ORIG-1 OXYBUTYNIN CHLORIDE ZYDUS PHARMS Approval
06/26/2017 PANTOPRAZOLE SODIUM
ANDA #202882		 SUPPL-7 PANTOPRAZOLE SODIUM HETERO LABS LTD V Labeling Approval
06/26/2017 TAMSULOSIN HYDROCHLORIDE
ANDA #204645		 SUPPL-1 TAMSULOSIN HYDROCHLORIDE MACLEODS PHARMS LTD Manufacturing (CMC) Approval
06/26/2017 AUROVELA 1.5/30
ANDA #207581		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE AUROBINDO PHARMA Approval
06/27/2017 THALOMID
NDA #020785		 SUPPL-63 THALIDOMIDE BRISTOL-MYERS REMS Approval
06/27/2017 REVLIMID
NDA #021880		 SUPPL-50 LENALIDOMIDE BRISTOL MYERS SQUIBB REMS Approval
06/27/2017 DULERA
NDA #022518		 SUPPL-21 FORMOTEROL FUMARATE; MOMETASONE FUROATE ORGANON LLC Labeling Approval
06/27/2017 OCTREOTIDE ACETATE
ANDA #075957		 SUPPL-25 OCTREOTIDE ACETATE MEITHEAL Labeling Approval
06/27/2017 OCTREOTIDE ACETATE
ANDA #075959		 SUPPL-26 OCTREOTIDE ACETATE MEITHEAL Labeling Approval
06/27/2017 METHADONE HYDROCHLORIDE INTENSOL
ANDA #089897		 SUPPL-36 METHADONE HYDROCHLORIDE HIKMA Labeling Approval
06/27/2017 ELETRIPTAN HYDROBROMIDE
ANDA #202040		 ORIG-1 ELETRIPTAN HYDROBROMIDE TEVA PHARMS USA Approval
06/27/2017 POMALYST
NDA #204026		 SUPPL-16 POMALIDOMIDE BRISTOL REMS Approval
06/27/2017 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ANDA #204087		 ORIG-1 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE ENCUBE Approval
06/27/2017 TRANEXAMIC ACID
ANDA #206713		 ORIG-1 TRANEXAMIC ACID MICRO LABS Approval
06/27/2017 DEXTROAMPHETAMINE SULFATE
ANDA #209111		 ORIG-1 DEXTROAMPHETAMINE SULFATE NESHER PHARMS Approval
06/27/2017 IBUPROFEN
ANDA #209207		 ORIG-1 IBUPROFEN TARO Approval
06/28/2017 XARELTO
NDA #022406		 SUPPL-23 RIVAROXABAN JANSSEN PHARMS Labeling Approval
06/28/2017 AZITHROMYCIN
ANDA #065246		 SUPPL-19 AZITHROMYCIN PLIVA Labeling Approval
06/28/2017 AZITHROMYCIN
ANDA #065246		 SUPPL-22 AZITHROMYCIN PLIVA Labeling Approval
06/28/2017 AZITHROMYCIN
ANDA #065246		 SUPPL-23 AZITHROMYCIN PLIVA Labeling Approval
06/28/2017 AZITHROMYCIN
ANDA #065246		 SUPPL-24 AZITHROMYCIN PLIVA Labeling Approval
06/28/2017 OCTREOTIDE ACETATE
ANDA #077372		 SUPPL-10 OCTREOTIDE ACETATE SUN PHARM INDS Labeling Approval
06/28/2017 OCTREOTIDE ACETATE
ANDA #077373		 SUPPL-8 OCTREOTIDE ACETATE SUN PHARM INDS Labeling Approval
06/28/2017 ZIDOVUDINE
ANDA #078349		 SUPPL-20 ZIDOVUDINE CIPLA LTD Labeling Approval
06/28/2017 ZIDOVUDINE
ANDA #078349		 SUPPL-21 ZIDOVUDINE CIPLA LTD Labeling Approval
06/28/2017 HYDROCORTISONE
ANDA #083365		 SUPPL-41 HYDROCORTISONE HIKMA INTL PHARMS Labeling Approval
06/28/2017 HYDROCORTISONE
ANDA #083365		 SUPPL-43 HYDROCORTISONE HIKMA INTL PHARMS Labeling Approval
06/28/2017 HYDROCORTISONE
ANDA #083365		 SUPPL-45 HYDROCORTISONE HIKMA INTL PHARMS Labeling Approval
06/28/2017 HYDROCORTISONE
ANDA #083365		 SUPPL-46 HYDROCORTISONE HIKMA INTL PHARMS Labeling Approval
06/28/2017 OLOPATADINE HYDROCHLORIDE
ANDA #200810		 ORIG-1 OLOPATADINE HYDROCHLORIDE GLENMARK PHARMS INC Approval
06/28/2017 QUETIAPINE FUMARATE
ANDA #202674		 SUPPL-1 QUETIAPINE FUMARATE UNICHEM Labeling Approval
06/28/2017 QUETIAPINE FUMARATE
ANDA #202674		 SUPPL-4 QUETIAPINE FUMARATE UNICHEM Labeling Approval
06/28/2017 LO MINASTRIN FE
NDA #204654		 SUPPL-6 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Labeling Approval
06/28/2017 PHENTERMINE HYDROCHLORIDE
ANDA #204663		 ORIG-1 PHENTERMINE HYDROCHLORIDE ZYDUS PHARMS Approval
06/28/2017 TELMISARTAN
ANDA #205150		 SUPPL-3 TELMISARTAN INVENTIA Manufacturing (CMC) Approval
06/28/2017 TOBRAMYCIN
ANDA #207444		 ORIG-1 TOBRAMYCIN SOMERSET THERAPS LLC Approval
06/28/2017 DOXEPIN HYDROCHLORIDE
ANDA #207482		 ORIG-1 DOXEPIN HYDROCHLORIDE AMNEAL PHARMS CO Approval
06/28/2017 CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
ANDA #208084		 ORIG-1 CLINDAMYCIN PHOSPHATE BAXTER HLTHCARE CORP Approval
06/29/2017 NORVIR
NDA #020659		 SUPPL-66 RITONAVIR ABBVIE Labeling Approval
06/29/2017 NORVIR
NDA #020945		 SUPPL-44 RITONAVIR ABBVIE Labeling Approval
06/29/2017 NORVIR
NDA #022417		 SUPPL-18 RITONAVIR ABBVIE Labeling Approval
06/29/2017 OXYCODONE AND ASPIRIN
ANDA #040255		 SUPPL-26 ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE ANI PHARMS Labeling Approval
06/29/2017 CLOZAPINE
ANDA #075713		 SUPPL-38 CLOZAPINE SUN PHARM INDS INC Labeling Approval
06/29/2017 CLOZAPINE
ANDA #075713		 SUPPL-39 CLOZAPINE SUN PHARM INDS INC Labeling Approval
06/29/2017 CLOZAPINE
ANDA #075713		 SUPPL-41 CLOZAPINE SUN PHARM INDS INC Labeling Approval
06/29/2017 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #077184		 SUPPL-13 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
06/29/2017 TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
ANDA #078778		 SUPPL-5 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE NOSTRUM LABS INC Labeling Approval
06/29/2017 IMIPRAMINE HYDROCHLORIDE
ANDA #087846		 SUPPL-29 IMIPRAMINE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/29/2017 TOFRANIL
ANDA #087846		 SUPPL-29 IMIPRAMINE HYDROCHLORIDE SPECGX LLC Labeling Approval
06/29/2017 VECTIBIX
BLA #125147		 SUPPL-207 PANITUMUMAB AMGEN Approval
06/29/2017 OXYCODONE HYDROCHLORIDE
ANDA #203107		 SUPPL-1 OXYCODONE HYDROCHLORIDE DR REDDYS LABS SA Labeling Approval
06/29/2017 OTEZLA
NDA #205437		 SUPPL-6 APREMILAST AMGEN INC Labeling Approval
06/29/2017 LONSURF
NDA #207981		 SUPPL-6 TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE TAIHO ONCOLOGY Labeling Approval
06/29/2017 TRIPTODUR KIT
NDA #208956		 ORIG-1 TRIPTORELIN PAMOATE AZURITY Type 5 - New Formulation or New Manufacturer Approval
06/29/2017 NORVIR
NDA #209512		 SUPPL-1 RITONAVIR ABBVIE Labeling Approval
06/30/2017 DESYREL
NDA #018207		 SUPPL-32 TRAZODONE HYDROCHLORIDE PRAGMA Labeling Approval
06/30/2017 PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PRISMASOL BGK 2/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PRISMASOL BGK 4/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PRISMASOL BK 0/0 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER
NDA #021703		 SUPPL-18 CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 BUPROPION HYDROCHLORIDE
ANDA #075914		 SUPPL-29 BUPROPION HYDROCHLORIDE IMPAX LABS Labeling Approval
06/30/2017 LEFLUNOMIDE
ANDA #077090		 SUPPL-13 LEFLUNOMIDE APOTEX INC Labeling Approval
06/30/2017 BUPROPION HYDROCHLORIDE
ANDA #077475		 SUPPL-18 BUPROPION HYDROCHLORIDE SANDOZ Labeling Approval
06/30/2017 BUPROPION HYDROCHLORIDE
ANDA #077475		 SUPPL-19 BUPROPION HYDROCHLORIDE SANDOZ Labeling Approval
06/30/2017 PRAVASTATIN SODIUM
ANDA #077987		 SUPPL-13 PRAVASTATIN SODIUM GLENMARK PHARMS LTD Labeling Approval
06/30/2017 BUPROPION HYDROCHLORIDE
ANDA #079094		 SUPPL-24 BUPROPION HYDROCHLORIDE ACTAVIS LABS FL INC Labeling Approval
06/30/2017 MOXIFLOXACIN HYDROCHLORIDE
ANDA #090080		 ORIG-1 MOXIFLOXACIN HYDROCHLORIDE APOTEX Approval
06/30/2017 QUETIAPINE FUMARATE
ANDA #090120		 SUPPL-6 QUETIAPINE FUMARATE HIKMA Labeling Approval
06/30/2017 QUETIAPINE FUMARATE
ANDA #090120		 SUPPL-7 QUETIAPINE FUMARATE HIKMA Labeling Approval
06/30/2017 ACTIVASE
BLA #103172		 SUPPL-5253 ALTEPLASE GENENTECH Approval
06/30/2017 CATHFLO ACTIVASE
BLA #103172		 SUPPL-5253 ALTEPLASE GENENTECH Approval
06/30/2017 ORENCIA
BLA #125118		 SUPPL-209 ABATACEPT BRISTOL MYERS SQUIBB Approval
06/30/2017 QUETIAPINE FUMARATE
ANDA #201109		 SUPPL-8 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
06/30/2017 QUETIAPINE FUMARATE
ANDA #201109		 SUPPL-10 QUETIAPINE FUMARATE LUPIN LTD Labeling Approval
06/30/2017 QUETIAPINE FUMARATE
ANDA #202152		 SUPPL-9 QUETIAPINE FUMARATE ACCORD HLTHCARE Labeling Approval
06/30/2017 QUETIAPINE FUMARATE
ANDA #202152		 SUPPL-10 QUETIAPINE FUMARATE ACCORD HLTHCARE Labeling Approval
06/30/2017 QUETIAPINE FUMARATE
ANDA #203359		 SUPPL-2 QUETIAPINE FUMARATE MACLEODS PHARMS LTD Labeling Approval
06/30/2017 QUETIAPINE FUMARATE
ANDA #203359		 SUPPL-3 QUETIAPINE FUMARATE MACLEODS PHARMS LTD Labeling Approval
06/30/2017 QUETIAPINE FUMARATE
ANDA #203390		 SUPPL-1 QUETIAPINE FUMARATE ALEMBIC Labeling Approval
06/30/2017 QUETIAPINE FUMARATE
ANDA #203390		 SUPPL-2 QUETIAPINE FUMARATE ALEMBIC Labeling Approval
06/30/2017 EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
NDA #204119		 ORIG-1 EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE HETERO DRUGS LTD Type 4 - New Combination Tentative Approval
06/30/2017 BUPROPION HYDROCHLORIDE
ANDA #206122		 SUPPL-1 BUPROPION HYDROCHLORIDE SCIEGEN PHARMS INC Labeling Approval
06/30/2017 ZOLMITRIPTAN
ANDA #206973		 ORIG-1 ZOLMITRIPTAN APPCO Approval
06/30/2017 PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER
NDA #207026		 SUPPL-4 CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER
NDA #207026		 SUPPL-4 CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE BAXTER HLTHCARE CORP Labeling Approval
06/30/2017 BUPROPION HYDROCHLORIDE
ANDA #207224		 ORIG-1 BUPROPION HYDROCHLORIDE ANBISON LAB Approval
06/30/2017 BUPROPION HYDROCHLORIDE
ANDA #207459		 ORIG-1 BUPROPION HYDROCHLORIDE JUBILANT GENERICS Approval
06/30/2017 ANAGRELIDE HYDROCHLORIDE
ANDA #209151		 ORIG-1 ANAGRELIDE HYDROCHLORIDE TORRENT Approval
06/30/2017 PROMETHAZINE HYDROCHLORIDE
ANDA #209177		 ORIG-1 PROMETHAZINE HYDROCHLORIDE STRIDES PHARMA Approval
06/30/2017 PANTOPRAZOLE SODIUM
NDA #209463		 ORIG-1 PANTOPRAZOLE SODIUM HIKMA Type 5 - New Formulation or New Manufacturer Approval
Back to Top