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
July 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 August 18, 2026.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
07/02/2018 LEVAQUIN
NDA #020634		 SUPPL-69 LEVOFLOXACIN JANSSEN PHARMS Labeling Approval
07/02/2018 PENICILLIN G PROCAINE
ANDA #060101		 SUPPL-31 PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
07/02/2018 PENICILLIN G PROCAINE
ANDA #060101		 SUPPL-35 PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
07/02/2018 PENICILLIN G PROCAINE
ANDA #060101		 SUPPL-38 PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
07/02/2018 EMTRICITABINE
ANDA #091168		 ORIG-1 EMTRICITABINE CIPLA Approval
07/02/2018 CHOLESTYRAMINE
ANDA #202901		 ORIG-1 CHOLESTYRAMINE ZYDUS PHARMS Approval
07/02/2018 OXYCODONE AND ACETAMINOPHEN
ANDA #203864		 ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE EPIC PHARMA LLC Approval
07/02/2018 DESOXIMETASONE
ANDA #205594		 ORIG-1 DESOXIMETASONE RISING Approval
07/02/2018 CASPOFUNGIN ACETATE
ANDA #205923		 ORIG-1 CASPOFUNGIN ACETATE XELLIA PHARMS APS Approval
07/02/2018 PROPAFENONE HYDROCHLORIDE
ANDA #205956		 ORIG-1 PROPAFENONE HYDROCHLORIDE RISING Approval
07/02/2018 ILOPERIDONE
ANDA #207409		 ORIG-1 ILOPERIDONE ALEMBIC PHARMS LTD Tentative Approval
07/02/2018 AZACITIDINE
ANDA #207475		 ORIG-1 AZACITIDINE ACCORD HLTHCARE Approval
07/02/2018 MONTELUKAST SODIUM
ANDA #208621		 ORIG-1 MONTELUKAST SODIUM UNICHEM Approval
07/02/2018 CAPECITABINE
ANDA #209365		 ORIG-1 CAPECITABINE MSN Approval
07/02/2018 OXYCODONE AND ACETAMINOPHEN
ANDA #209385		 ORIG-1 ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE ELITE LABS INC Approval
07/02/2018 NICOTINE POLACRILEX
ANDA #209519		 ORIG-1 NICOTINE POLACRILEX P AND L Approval
07/02/2018 DOCETAXEL
ANDA #210072		 ORIG-1 DOCETAXEL MYLAN LABS LTD Approval
07/02/2018 DICYCLOMINE HYDROCHLORIDE
ANDA #210979		 ORIG-1 DICYCLOMINE HYDROCHLORIDE FOSUN PHARMA Approval
07/02/2018 TECENTRIQ
BLA #761034		 SUPPL-12 ATEZOLIZUMAB GENENTECH INC Approval
07/03/2018 PHOSPHOLINE IODIDE
NDA #011963		 SUPPL-48 ECHOTHIOPHATE IODIDE FERA PHARMS LLC Labeling Approval
07/03/2018 ARRANON
NDA #021877		 SUPPL-8 NELARABINE SANDOZ Labeling Approval
07/03/2018 ARGATROBAN IN SODIUM CHLORIDE
NDA #022485		 SUPPL-11 ARGATROBAN PLANO PHARMS Labeling Approval
07/03/2018 Xeomin
BLA #125360		 SUPPL-73 incobotulinumtoxinA MERZ PHARMS Approval
07/03/2018 LEVONORGESTREL
ANDA #204044		 ORIG-1 LEVONORGESTREL LABORATOIRE HRA Approval
07/03/2018 BUDESONIDE
ANDA #205457		 ORIG-1 BUDESONIDE ACTAVIS LABS FL INC Approval
07/03/2018 OLANZAPINE
ANDA #208146		 ORIG-1 OLANZAPINE HEC PHARM Approval
07/03/2018 VEMLIDY
NDA #208464		 SUPPL-4 TENOFOVIR ALAFENAMIDE FUMARATE GILEAD SCIENCES INC Efficacy Approval
07/03/2018 HALOPERIDOL DECANOATE
ANDA #209101		 ORIG-1 HALOPERIDOL DECANOATE SOMERSET THERAPS LLC Approval
07/05/2018 ROBINUL
NDA #017558		 SUPPL-62 GLYCOPYRROLATE HIKMA Labeling Approval
07/05/2018 CLARITIN
NDA #019658		 SUPPL-53 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
07/05/2018 CLARITIN HIVES RELIEF
NDA #019658		 SUPPL-53 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
07/05/2018 FASLODEX
NDA #021344		 SUPPL-36 FULVESTRANT ASTRAZENECA Efficacy Approval
07/05/2018 TEMOZOLOMIDE
ANDA #204159		 ORIG-1 TEMOZOLOMIDE APOTEX Approval
07/05/2018 HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
ANDA #207176		 SUPPL-1 HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE AVANTHI INC Labeling Approval
07/05/2018 AZITHROMYCIN
ANDA #207370		 ORIG-1 AZITHROMYCIN AUROBINDO PHARMA LTD Approval
07/05/2018 AZITHROMYCIN
ANDA #207398		 ORIG-1 AZITHROMYCIN AUROBINDO PHARMA LTD Approval
07/05/2018 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
ANDA #207487		 SUPPL-1 HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE ABHAI LLC Labeling Approval
07/05/2018 PHENYLEPHRINE HYDROCHLORIDE
ANDA #211079		 ORIG-1 PHENYLEPHRINE HYDROCHLORIDE AMNEAL Approval
07/06/2018 GLUCAGEN
NDA #020918		 SUPPL-52 GLUCAGON HYDROCHLORIDE NOVO NORDISK Labeling Approval
07/06/2018 GLUCAGON
NDA #020928		 SUPPL-56 GLUCAGON LILLY Labeling Approval
07/06/2018 ADEFOVIR DIPIVOXIL
ANDA #205459		 ORIG-1 ADEFOVIR DIPIVOXIL APOTEX Approval
07/06/2018 EPINEPHRINE
ANDA #207568		 ORIG-1 EPINEPHRINE AM REGENT Approval
07/06/2018 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #209192		 ORIG-1 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Approval
07/06/2018 DOLUTEGRAVIR SODIUM
ANDA #209602		 ORIG-1 DOLUTEGRAVIR SODIUM MYLAN LABS LTD Tentative Approval
07/06/2018 VABOMERE
NDA #209776		 SUPPL-1 MEROPENEM; VABORBACTAM REMPEX Labeling Approval
07/06/2018 HYDROXYCHLOROQUINE SULFATE
ANDA #210543		 ORIG-1 HYDROXYCHLOROQUINE SULFATE CHARTWELL RX Approval
07/06/2018 DOCETAXEL
ANDA #210848		 ORIG-1 DOCETAXEL MYLAN LABS LTD Approval
07/09/2018 NITROFURANTOIN
ANDA #203233		 ORIG-1 NITROFURANTOIN, MACROCRYSTALLINE NOVEL LABS INC Approval
07/09/2018 TOBRAMYCIN
ANDA #207080		 ORIG-1 TOBRAMYCIN DR REDDYS LABS SA Approval
07/09/2018 ALPRAZOLAM
ANDA #207507		 ORIG-1 ALPRAZOLAM CHARTWELL RX Approval
07/09/2018 CLARITHROMYCIN
ANDA #208987		 ORIG-1 CLARITHROMYCIN SUNSHINE Approval
07/09/2018 HYDRALAZINE HYDROCHLORIDE
ANDA #209251		 ORIG-1 HYDRALAZINE HYDROCHLORIDE RISING Approval
07/09/2018 ATROPINE (AUTOINJECTOR)
NDA #212319		 ORIG-1 ATROPINE RAFA LABS LTD Type 5 - New Formulation or New Manufacturer Approval
07/10/2018 CIMDUO
NDA #022141		 SUPPL-24 LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE MYLAN LABS LTD Approval
07/10/2018 CARBIDOPA AND LEVODOPA
ANDA #078536		 SUPPL-15 CARBIDOPA; LEVODOPA SUN PHARM INDS Manufacturing (CMC) Approval
07/10/2018 YERVOY
BLA #125377		 SUPPL-96 IPILIMUMAB BRISTOL MYERS SQUIBB Approval
07/10/2018 OPDIVO
BLA #125554		 SUPPL-63 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
07/10/2018 NEURACEQ
NDA #204677		 SUPPL-15 FLORBETABEN F-18 LANTHEUS Manufacturing (CMC) Approval
07/10/2018 SAXAGLIPTIN
ANDA #206020		 ORIG-1 SAXAGLIPTIN TEVA PHARMS USA Tentative Approval
07/10/2018 NEOSTIGMINE METHYLSULFATE
ANDA #209135		 ORIG-1 NEOSTIGMINE METHYLSULFATE DR REDDYS Approval
07/10/2018 VANCOMYCIN HYDROCHLORIDE
NDA #209481		 ORIG-1 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Type 5 - New Formulation or New Manufacturer Approval
07/11/2018 PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #017385		 SUPPL-64 DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Approval
07/11/2018 DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER
NDA #017484		 SUPPL-74 DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Approval
07/11/2018 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
NDA #018629		 SUPPL-48 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Approval
07/11/2018 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
NDA #018629		 SUPPL-48 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Approval
07/11/2018 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
NDA #018629		 SUPPL-48 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Approval
07/11/2018 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
NDA #018629		 SUPPL-48 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Approval
07/11/2018 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
NDA #018629		 SUPPL-48 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Approval
07/11/2018 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
NDA #018629		 SUPPL-48 DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Approval
07/11/2018 MEMANTINE HYDROCHLORIDE
ANDA #090244		 ORIG-1 MEMANTINE HYDROCHLORIDE CHARTWELL Approval
07/11/2018 NAFCILLIN SODIUM
ANDA #091613		 SUPPL-4 NAFCILLIN SODIUM EUGIA PHARMA SPECLTS Manufacturing (CMC) Approval
07/11/2018 ZOLMITRIPTAN
ANDA #203019		 ORIG-1 ZOLMITRIPTAN ZYDUS PHARMS Approval
07/11/2018 DALFAMPRIDINE
ANDA #206863		 ORIG-1 DALFAMPRIDINE ACCORD HLTHCARE Approval
07/11/2018 DIHYDROERGOTAMINE MESYLATE
ANDA #207264		 ORIG-1 DIHYDROERGOTAMINE MESYLATE SAGENT PHARMS INC Approval
07/11/2018 GUAIFENESIN
ANDA #207342		 ORIG-1 GUAIFENESIN AMNEAL PHARMS Approval
07/11/2018 GLYRX-PF
NDA #210997		 ORIG-1 GLYCOPYRROLATE EXELA PHARMA Type 5 - New Formulation or New Manufacturer Approval
07/11/2018 GLYRX-PF
NDA #210997		 ORIG-2 GLYCOPYRROLATE EXELA PHARMA Efficacy Approval
07/12/2018 ROCEPHIN
NDA #050585		 SUPPL-68 CEFTRIAXONE SODIUM HOFFMANN LA ROCHE Labeling Approval
07/12/2018 ROCEPHIN KIT
NDA #050585		 SUPPL-68 CEFTRIAXONE SODIUM; LIDOCAINE HOFFMANN LA ROCHE Labeling Approval
07/12/2018 LEVETIRACETAM IN SODIUM CHLORIDE
NDA #202543		 SUPPL-11 LEVETIRACETAM HQ SPCLT PHARMA Labeling Approval
07/12/2018 BELSOMRA
NDA #204569		 SUPPL-5 SUVOREXANT MERCK SHARP DOHME Labeling Approval
07/12/2018 BORTEZOMIB
NDA #205004		 SUPPL-2 BORTEZOMIB FRESENIUS KABI USA Labeling Approval
07/12/2018 OMEPRAZOLE
NDA #209400		 SUPPL-3 OMEPRAZOLE DEXCEL Labeling Approval
07/12/2018 CASPOFUNGIN ACETATE
ANDA #209489		 ORIG-1 CASPOFUNGIN ACETATE CIPLA Approval
07/13/2018 DETROL LA
NDA #021228		 SUPPL-23 TOLTERODINE TARTRATE UPJOHN Labeling Approval
07/13/2018 OXYTOCIN
ANDA #091676		 ORIG-1 OXYTOCIN SAGENT PHARMS INC Approval
07/13/2018 KRYSTEXXA
BLA #125293		 SUPPL-92 PEGLOTICASE HORIZON PHARMA Approval
07/13/2018 XTANDI
NDA #203415		 SUPPL-14 ENZALUTAMIDE ASTELLAS Efficacy Approval
07/13/2018 BUSULFAN
ANDA #205184		 ORIG-1 BUSULFAN PHARMOBEDIENT Approval
07/13/2018 IMATINIB MESYLATE
ANDA #207586		 ORIG-1 IMATINIB MESYLATE HIKMA Approval
07/13/2018 MOMETASONE FUROATE
ANDA #207899		 ORIG-1 MOMETASONE FUROATE TORRENT Approval
07/13/2018 ROFLUMILAST
ANDA #208257		 ORIG-1 ROFLUMILAST PHARMOBEDIENT Approval
07/13/2018 TPOXX
NDA #208627		 ORIG-1 TECOVIRIMAT SIGA TECHNOLOGIES Type 1 - New Molecular Entity Approval
07/13/2018 NIPRIDE RTU IN SODIUM CHLORIDE 0.9%
NDA #209387		 SUPPL-4 SODIUM NITROPRUSSIDE EXELA PHARMA Manufacturing (CMC) Approval
07/13/2018 VERAPAMIL HYDROCHLORIDE
ANDA #210994		 ORIG-1 VERAPAMIL HYDROCHLORIDE AMNEAL Approval
07/16/2018 TIMOPTIC-XE
NDA #020330		 SUPPL-32 TIMOLOL MALEATE BAUSCH AND LOMB INC Labeling Approval
07/16/2018 ADDERALL XR 10
NDA #021303		 SUPPL-29 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/16/2018 ADDERALL XR 15
NDA #021303		 SUPPL-29 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/16/2018 ADDERALL XR 20
NDA #021303		 SUPPL-29 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/16/2018 ADDERALL XR 25
NDA #021303		 SUPPL-29 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/16/2018 ADDERALL XR 30
NDA #021303		 SUPPL-29 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/16/2018 ADDERALL XR 5
NDA #021303		 SUPPL-29 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TAKEDA PHARMS USA Labeling Approval
07/16/2018 INTELENCE
NDA #022187		 SUPPL-24 ETRAVIRINE JANSSEN R AND D Efficacy Approval
07/16/2018 BIVALIRUDIN
ANDA #091602		 ORIG-1 BIVALIRUDIN MEITHEAL Approval
07/16/2018 COLESEVELAM HYDROCHLORIDE
ANDA #202190		 ORIG-1 COLESEVELAM HYDROCHLORIDE GLENMARK PHARMS LTD Approval
07/16/2018 POLMON
ANDA #202520		 ORIG-1 DEXCHLORPHENIRAMINE MALEATE PHARMOBEDIENT Approval
07/16/2018 GLIPIZIDE
ANDA #203499		 ORIG-1 GLIPIZIDE ZYDUS PHARMS Approval
07/16/2018 MITIGO
ANDA #204393		 ORIG-1 MORPHINE SULFATE PIRAMAL CRITICAL Approval
07/16/2018 INFUGEM
NDA #208313		 ORIG-1 GEMCITABINE HYDROCHLORIDE SUN PHARM Type 3 - New Dosage Form Approval
07/16/2018 CLINDAMYCIN PHOSPHATE
ANDA #208767		 ORIG-1 CLINDAMYCIN PHOSPHATE ZYDUS LIFESCIENCES Approval
07/16/2018 VORICONAZOLE
ANDA #208983		 ORIG-1 VORICONAZOLE ZYDUS PHARMS Approval
07/16/2018 GUAIFENESIN
ANDA #209254		 ORIG-1 GUAIFENESIN OHM LABS INC Approval
07/16/2018 DEXTROSE 10% IN PLASTIC CONTAINER
ANDA #209448		 ORIG-1 DEXTROSE FRESENIUS KABI USA Approval
07/16/2018 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ANDA #209609		 ORIG-1 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE XIROMED Approval
07/16/2018 SODIUM NITROPRUSSIDE
ANDA #210855		 ORIG-1 SODIUM NITROPRUSSIDE CIPLA Approval
07/16/2018 RANITIDINE HYDROCHLORIDE
ANDA #211058		 ORIG-1 RANITIDINE HYDROCHLORIDE AUROBINDO PHARMA Approval
07/17/2018 IMITREX
NDA #020080		 SUPPL-52 SUMATRIPTAN SUCCINATE GLAXOSMITHKLINE Labeling Approval
07/17/2018 IMITREX STATDOSE
NDA #020080		 SUPPL-52 SUMATRIPTAN SUCCINATE GLAXOSMITHKLINE Labeling Approval
07/17/2018 GALANTAMINE HYDROBROMIDE
ANDA #077608		 SUPPL-3 GALANTAMINE HYDROBROMIDE HIKMA Labeling Approval
07/17/2018 GALANTAMINE HYDROBROMIDE
ANDA #077608		 SUPPL-5 GALANTAMINE HYDROBROMIDE HIKMA Labeling Approval
07/17/2018 GALANTAMINE HYDROBROMIDE
ANDA #078185		 SUPPL-5 GALANTAMINE HYDROBROMIDE HIKMA Labeling Approval
07/17/2018 GALANTAMINE HYDROBROMIDE
ANDA #078185		 SUPPL-6 GALANTAMINE HYDROBROMIDE HIKMA Labeling Approval
07/17/2018 OLANZAPINE
ANDA #090459		 ORIG-1 OLANZAPINE ZYDUS PHARMS Approval
07/17/2018 PIROXICAM
ANDA #205585		 ORIG-1 PIROXICAM ZYDUS LIFESCIENCES Approval
07/17/2018 CYTARABINE
ANDA #205696		 ORIG-1 CYTARABINE MEITHEAL Approval
07/17/2018 FLUOCINONIDE
ANDA #208948		 ORIG-1 FLUOCINONIDE ZYDUS PHARMS Approval
07/17/2018 SYMTUZA
NDA #210455		 ORIG-1 COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE JANSSEN PRODS Type 4 - New Combination Approval
07/18/2018 SELZENTRY
NDA #022128		 SUPPL-18 MARAVIROC VIIV HLTHCARE Labeling Approval
07/18/2018 SPIRONOLACTONE
ANDA #205936		 ORIG-1 SPIRONOLACTONE ZYDUS PHARMS Approval
07/18/2018 SELZENTRY
NDA #208984		 SUPPL-1 MARAVIROC VIIV HLTHCARE Labeling Approval
07/18/2018 KISQALI
NDA #209092		 SUPPL-1 RIBOCICLIB SUCCINATE NOVARTIS Efficacy Approval
07/19/2018 BIO-TROPIN
BLA #019774		 SUPPL-48 SOMATROPIN FERRING Approval
07/19/2018 BIO-TROPIN
BLA #019774		 SUPPL-49 SOMATROPIN FERRING Approval
07/19/2018 BIO-TROPIN
BLA #019774		 SUPPL-50 SOMATROPIN FERRING Approval
07/19/2018 BIO-TROPIN
BLA #019774		 SUPPL-51 SOMATROPIN FERRING Approval
07/19/2018 ZOMACTON
BLA #019774		 SUPPL-48 SOMATROPIN FERRING Approval
07/19/2018 ZOMACTON
BLA #019774		 SUPPL-49 SOMATROPIN FERRING Approval
07/19/2018 ZOMACTON
BLA #019774		 SUPPL-50 SOMATROPIN FERRING Approval
07/19/2018 ZOMACTON
BLA #019774		 SUPPL-51 SOMATROPIN FERRING Approval
07/19/2018 CILOSTAZOL
ANDA #077028		 SUPPL-3 CILOSTAZOL ACTAVIS ELIZABETH Labeling Approval
07/19/2018 QUINAPRIL HYDROCHLORIDE
ANDA #077690		 SUPPL-29 QUINAPRIL HYDROCHLORIDE LUPIN Labeling Approval
07/19/2018 QUINAPRIL HYDROCHLORIDE
ANDA #077690		 SUPPL-30 QUINAPRIL HYDROCHLORIDE LUPIN Labeling Approval
07/19/2018 ROCURONIUM BROMIDE
ANDA #078519		 SUPPL-13 ROCURONIUM BROMIDE HOSPIRA Labeling Approval
07/19/2018 MORPHINE SULFATE
ANDA #200411		 SUPPL-5 MORPHINE SULFATE IMPAX LABS INC Labeling Approval
07/19/2018 DULOXETINE HYDROCHLORIDE
ANDA #204343		 SUPPL-1 DULOXETINE HYDROCHLORIDE HETERO LABS LTD III Labeling Approval
07/19/2018 OXCARBAZEPINE
ANDA #205444		 ORIG-1 OXCARBAZEPINE ACTAVIS LABS FL INC Tentative Approval
07/19/2018 AZITHROMYCIN
ANDA #205666		 ORIG-1 AZITHROMYCIN AMNEAL Approval
07/19/2018 POTASSIUM CHLORIDE
ANDA #210041		 ORIG-1 POTASSIUM CHLORIDE AMNEAL Approval
07/19/2018 PHENYLEPHRINE HYDROCHLORIDE
ANDA #211078		 ORIG-1 PHENYLEPHRINE HYDROCHLORIDE AMNEAL Approval
07/20/2018 AVAPRO
NDA #020757		 SUPPL-69 IRBESARTAN SANOFI AVENTIS US Labeling Approval
07/20/2018 AVALIDE
NDA #020758		 SUPPL-73 HYDROCHLOROTHIAZIDE; IRBESARTAN SANOFI AVENTIS US Labeling Approval
07/20/2018 CHILDREN'S CLARITIN
NDA #021891		 SUPPL-27 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
07/20/2018 CLARITIN
NDA #021891		 SUPPL-27 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
07/20/2018 CLARITIN
NDA #021952		 SUPPL-17 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
07/20/2018 VIDAZA
NDA #050794		 SUPPL-31 AZACITIDINE BRISTOL-MYERS Labeling Approval
07/20/2018 PRALUENT
BLA #125559		 SUPPL-15 ALIROCUMAB REGENERON PHARMACEUTICALS Approval
07/20/2018 SUMATRIPTAN AND NAPROXEN SODIUM
ANDA #202803		 ORIG-1 NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE SUN PHARM Approval
07/20/2018 LOTEMAX
NDA #202872		 SUPPL-2 LOTEPREDNOL ETABONATE BAUSCH AND LOMB INC Efficacy Approval
07/20/2018 EPTIFIBATIDE
ANDA #203258		 ORIG-1 EPTIFIBATIDE MYLAN LABS LTD Approval
07/20/2018 ELETRIPTAN HYDROBROMIDE
ANDA #205186		 SUPPL-2 ELETRIPTAN HYDROBROMIDE CHARTWELL RX Manufacturing (CMC) Approval
07/20/2018 ACETYLCYSTEINE
ANDA #208166		 ORIG-1 ACETYLCYSTEINE ZYDUS PHARMS Approval
07/20/2018 GEMCITABINE HYDROCHLORIDE
ANDA #209077		 ORIG-1 GEMCITABINE HYDROCHLORIDE SAGENT PHARMS INC Approval
07/20/2018 CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #209107		 ORIG-1 CETIRIZINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
07/20/2018 CETIRIZINE HYDROCHLORIDE HIVES RELIEF
ANDA #209107		 ORIG-1 CETIRIZINE HYDROCHLORIDE AUROBINDO PHARMA LTD Approval
07/20/2018 FENOFIBRATE
ANDA #210138		 ORIG-1 FENOFIBRATE AJANTA PHARMA LTD Approval
07/20/2018 OMEPRAZOLE MAGNESIUM
ANDA #210593		 ORIG-1 OMEPRAZOLE MAGNESIUM SPIL Approval
07/20/2018 KRINTAFEL
NDA #210795		 ORIG-1 TAFENOQUINE SUCCINATE GLAXOSMITHKLINE Type 1 - New Molecular Entity Approval
07/20/2018 PYRIDOSTIGMINE BROMIDE
ANDA #211181		 ORIG-1 PYRIDOSTIGMINE BROMIDE MLV Approval
07/20/2018 TIBSOVO
NDA #211192		 ORIG-1 IVOSIDENIB SERVIER Type 1 - New Molecular Entity Approval
07/20/2018 NIVESTYM
BLA #761080		 ORIG-1 FILGRASTIM-AAFI HOSPIRA INC Approval
07/22/2018 FIASP
BLA #208751		 SUPPL-2 INSULIN ASPART NOVO Approval
07/22/2018 FIASP FLEXTOUCH
BLA #208751		 SUPPL-2 INSULIN ASPART NOVO Approval
07/22/2018 FIASP PENFILL
BLA #208751		 SUPPL-2 INSULIN ASPART NOVO Approval
07/23/2018 LAMICTAL
NDA #020241		 SUPPL-56 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
07/23/2018 CLARITIN HIVES RELIEF REDITAB
NDA #020704		 SUPPL-33 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
07/23/2018 CLARITIN REDITABS
NDA #020704		 SUPPL-33 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
07/23/2018 LAMICTAL CD
NDA #020764		 SUPPL-49 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
07/23/2018 CLARITIN REDITABS
NDA #021993		 SUPPL-16 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
07/23/2018 LAMICTAL XR
NDA #022115		 SUPPL-22 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
07/23/2018 LAMICTAL ODT
NDA #022251		 SUPPL-20 LAMOTRIGINE GLAXOSMITHKLINE LLC Labeling Approval
07/23/2018 MONTELUKAST SODIUM
ANDA #200405		 SUPPL-9 MONTELUKAST SODIUM LANNETT CO INC Labeling Approval
07/23/2018 MONTELUKAST SODIUM
ANDA #201522		 SUPPL-9 MONTELUKAST SODIUM CHARTWELL MOLECULAR Labeling Approval
07/23/2018 BUPROPION HYDROCHLORIDE
ANDA #201567		 SUPPL-9 BUPROPION HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
07/23/2018 BUPROPION HYDROCHLORIDE
ANDA #201567		 SUPPL-10 BUPROPION HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
07/23/2018 BUPROPION HYDROCHLORIDE
ANDA #201567		 SUPPL-11 BUPROPION HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
07/23/2018 MONTELUKAST SODIUM
ANDA #202096		 SUPPL-16 MONTELUKAST SODIUM AUROBINDO PHARMA LTD Labeling Approval
07/23/2018 IBUPROFEN
ANDA #202413		 SUPPL-5 IBUPROFEN SHANDONG XINHUA Manufacturing (CMC) Approval
07/23/2018 MONTELUKAST SODIUM
ANDA #202468		 SUPPL-16 MONTELUKAST SODIUM AUROBINDO PHARMA LTD Labeling Approval
07/23/2018 HYDROCORTISONE
ANDA #203810		 ORIG-1 HYDROCORTISONE ENCUBE Approval
07/23/2018 PIROXICAM
ANDA #206136		 SUPPL-3 PIROXICAM STRIDES PHARMA Manufacturing (CMC) Approval
07/23/2018 NICOTINE POLACRILEX
ANDA #206394		 SUPPL-4 NICOTINE POLACRILEX PERRIGO R AND D Manufacturing (CMC) Approval
07/23/2018 VIEKIRA PAK (COPACKAGED)
NDA #206619		 SUPPL-18 DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR ABBVIE Labeling Approval
07/23/2018 TECHNIVIE
NDA #207931		 SUPPL-12 OMBITASVIR; PARITAPREVIR; RITONAVIR ABBVIE Labeling Approval
07/23/2018 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
ANDA #208122		 ORIG-1 SODIUM CHLORIDE FRESENIUS KABI USA Approval
07/23/2018 VIEKIRA XR
NDA #208624		 SUPPL-6 DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR ABBVIE Labeling Approval
07/23/2018 INGENOL MEBUTATE
ANDA #208807		 ORIG-1 INGENOL MEBUTATE ACTAVIS LABS UT INC Tentative Approval
07/23/2018 ESOMEPRAZOLE MAGNESIUM
ANDA #209735		 SUPPL-3 ESOMEPRAZOLE MAGNESIUM SUN PHARM Labeling Approval
07/23/2018 ORILISSA
NDA #210450		 ORIG-1 ELAGOLIX SODIUM ABBVIE Type 1 - New Molecular Entity Approval
07/23/2018 NADOLOL
ANDA #210955		 ORIG-1 NADOLOL REGCON HOLDINGS Approval
07/24/2018 MEDROL
NDA #011153		 SUPPL-75 METHYLPREDNISOLONE PFIZER Labeling Approval
07/24/2018 DEPO-MEDROL
NDA #011757		 SUPPL-114 METHYLPREDNISOLONE ACETATE PFIZER Labeling Approval
07/24/2018 SOLU-MEDROL
NDA #011856		 SUPPL-133 METHYLPREDNISOLONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Labeling Approval
07/24/2018 DALVANCE
NDA #021883		 SUPPL-7 DALBAVANCIN HYDROCHLORIDE ABBVIE Labeling Approval
07/24/2018 PROMACTA
NDA #022291		 SUPPL-20 ELTROMBOPAG OLAMINE NOVARTIS Labeling Approval
07/24/2018 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #090513		 SUPPL-9 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE AUROBINDO PHARMA REMS Approval
07/24/2018 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #090894		 SUPPL-3 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE TEVA PHARMS USA REMS Approval
07/24/2018 ETHACRYNIC ACID
ANDA #205709		 ORIG-1 ETHACRYNIC ACID ALVOGEN Approval
07/24/2018 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #206436		 SUPPL-1 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE PHARMOBEDIENT REMS Approval
07/24/2018 CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #206703		 ORIG-1 CYCLOBENZAPRINE HYDROCHLORIDE APOTEX Approval
07/24/2018 PROMACTA KIT
NDA #207027		 SUPPL-5 ELTROMBOPAG OLAMINE NOVARTIS Labeling Approval
07/24/2018 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #207630		 ORIG-1 DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EUGIA PHARMA Approval
07/24/2018 DOXERCALCIFEROL
NDA #208614		 ORIG-1 DOXERCALCIFEROL HOSPIRA Type 5 - New Formulation or New Manufacturer Approval
07/25/2018 INTRALIPID 10%
NDA #017643		 SUPPL-78 SOYBEAN OIL FRESENIUS Labeling Approval
07/25/2018 INTRALIPID 20%
NDA #018449		 SUPPL-45 SOYBEAN OIL FRESENIUS Labeling Approval
07/25/2018 MAGNEVIST
NDA #019596		 SUPPL-64 GADOPENTETATE DIMEGLUMINE BAYER HLTHCARE Labeling Approval
07/25/2018 MAGNEVIST
NDA #019596		 SUPPL-65 GADOPENTETATE DIMEGLUMINE BAYER HLTHCARE Labeling Approval
07/25/2018 INTRALIPID 30%
NDA #019942		 SUPPL-16 SOYBEAN OIL FRESENIUS Labeling Approval
07/25/2018 ALEVE
NDA #020204		 SUPPL-57 NAPROXEN SODIUM BAYER Labeling Approval
07/25/2018 INTRALIPID 20%
NDA #020248		 SUPPL-22 SOYBEAN OIL FRESENIUS Labeling Approval
07/25/2018 MAGNEVIST
NDA #021037		 SUPPL-37 GADOPENTETATE DIMEGLUMINE BAYER HLTHCARE Labeling Approval
07/25/2018 MAGNEVIST
NDA #021037		 SUPPL-38 GADOPENTETATE DIMEGLUMINE BAYER HLTHCARE Labeling Approval
07/25/2018 CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER
NDA #021117		 SUPPL-15 CALCIUM CHLORIDE HOSPIRA Labeling Approval
07/25/2018 ATRIPLA
NDA #021937		 SUPPL-43 EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES Labeling Approval
07/25/2018 EPOGEN/PROCRIT
BLA #103234		 SUPPL-5369 EPOETIN ALFA AMGEN Approval
07/25/2018 SOLIRIS
BLA #125166		 SUPPL-427 ECULIZUMAB ALEXION PHARM Approval
07/25/2018 SOLIRIS
BLA #125166		 SUPPL-428 ECULIZUMAB ALEXION PHARM Approval
07/25/2018 INDIUM IN 111 OXYQUINOLINE
ANDA #202586		 ORIG-1 INDIUM IN-111 OXYQUINOLINE BWXT ITG Approval
07/25/2018 VAZALORE
NDA #203697		 SUPPL-3 ASPIRIN PLX PHARMA Labeling Approval
07/25/2018 GUANFACINE HYDROCHLORIDE
ANDA #205430		 ORIG-1 GUANFACINE HYDROCHLORIDE APOTEX Approval
07/25/2018 TRULANCE
NDA #208745		 SUPPL-2 PLECANATIDE SALIX Labeling Approval
07/25/2018 MALMOREDE
ANDA #209547		 ORIG-1 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE NOVAST LABS Approval
07/25/2018 BEXAROTENE
ANDA #209886		 ORIG-1 BEXAROTENE UPSHER SMITH LABS Approval
07/26/2018 ANECTINE
NDA #008453		 SUPPL-36 SUCCINYLCHOLINE CHLORIDE SANDOZ Labeling Approval
07/26/2018 QUELICIN
NDA #008845		 SUPPL-73 SUCCINYLCHOLINE CHLORIDE HOSPIRA Labeling Approval
07/26/2018 QUELICIN PRESERVATIVE FREE
NDA #008845		 SUPPL-73 SUCCINYLCHOLINE CHLORIDE HOSPIRA Labeling Approval
07/26/2018 MIVACRON
NDA #020098		 SUPPL-19 MIVACURIUM CHLORIDE ABBVIE Labeling Approval
07/26/2018 MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020098		 SUPPL-19 MIVACURIUM CHLORIDE ABBVIE Labeling Approval
07/26/2018 ZEMURON
NDA #020214		 SUPPL-38 ROCURONIUM BROMIDE ORGANON USA INC Labeling Approval
07/26/2018 NIMBEX
NDA #020551		 SUPPL-20 CISATRACURIUM BESYLATE ABBVIE Labeling Approval
07/26/2018 NIMBEX
NDA #020551		 SUPPL-26 CISATRACURIUM BESYLATE ABBVIE Labeling Approval
07/26/2018 NIMBEX PRESERVATIVE FREE
NDA #020551		 SUPPL-20 CISATRACURIUM BESYLATE ABBVIE Labeling Approval
07/26/2018 NIMBEX PRESERVATIVE FREE
NDA #020551		 SUPPL-26 CISATRACURIUM BESYLATE ABBVIE Labeling Approval
07/26/2018 EOVIST
NDA #022090		 SUPPL-15 GADOXETATE DISODIUM BAYER HLTHCARE Labeling Approval
07/26/2018 PANCURONIUM BROMIDE
ANDA #072320		 SUPPL-28 PANCURONIUM BROMIDE HOSPIRA Labeling Approval
07/26/2018 PANCURONIUM BROMIDE
ANDA #072759		 SUPPL-26 PANCURONIUM BROMIDE DR REDDYS Labeling Approval
07/26/2018 PANCURONIUM BROMIDE
ANDA #072760		 SUPPL-26 PANCURONIUM BROMIDE DR REDDYS Labeling Approval
07/26/2018 VECURONIUM BROMIDE
ANDA #074688		 SUPPL-26 VECURONIUM BROMIDE MEITHEAL Labeling Approval
07/26/2018 ATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #074900		 SUPPL-20 ATRACURIUM BESYLATE HIKMA Labeling Approval
07/26/2018 ATRACURIUM BESYLATE
ANDA #074901		 SUPPL-20 ATRACURIUM BESYLATE HIKMA Labeling Approval
07/26/2018 VECURONIUM BROMIDE
ANDA #075164		 SUPPL-14 VECURONIUM BROMIDE HOSPIRA Labeling Approval
07/26/2018 VECURONIUM BROMIDE
ANDA #075218		 SUPPL-3 VECURONIUM BROMIDE HIKMA Labeling Approval
07/26/2018 VECURONIUM BROMIDE
ANDA #075549		 SUPPL-13 VECURONIUM BROMIDE HIKMA Labeling Approval
07/26/2018 VECURONIUM BROMIDE
ANDA #078274		 SUPPL-4 VECURONIUM BROMIDE SAGENT PHARMS INC Labeling Approval
07/26/2018 ROCURONIUM BROMIDE
ANDA #078519		 SUPPL-15 ROCURONIUM BROMIDE HOSPIRA Labeling Approval
07/26/2018 ROCURONIUM BROMIDE
ANDA #078651		 SUPPL-6 ROCURONIUM BROMIDE FRESENIUS KABI USA Labeling Approval
07/26/2018 ROCURONIUM BROMIDE
ANDA #078717		 SUPPL-21 ROCURONIUM BROMIDE TEVA PHARMS Labeling Approval
07/26/2018 VECURONIUM BROMIDE
ANDA #079001		 SUPPL-17 VECURONIUM BROMIDE SUN PHARM Labeling Approval
07/26/2018 ROCURONIUM BROMIDE
ANDA #079195		 SUPPL-16 ROCURONIUM BROMIDE SANDOZ Labeling Approval
07/26/2018 ROCURONIUM BROMIDE
ANDA #079199		 SUPPL-8 ROCURONIUM BROMIDE MYLAN INSTITUTIONAL Labeling Approval
07/26/2018 VECURONIUM BROMIDE
ANDA #090243		 SUPPL-11 VECURONIUM BROMIDE MYLAN LABS LTD Labeling Approval
07/26/2018 ATRACURIUM BESYLATE
ANDA #090761		 SUPPL-2 ATRACURIUM BESYLATE HOSPIRA INC Labeling Approval
07/26/2018 ATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #090782		 SUPPL-2 ATRACURIUM BESYLATE HOSPIRA INC Labeling Approval
07/26/2018 MONTELUKAST SODIUM
ANDA #091414		 SUPPL-10 MONTELUKAST SODIUM AIPING PHARM INC Labeling Approval
07/26/2018 ROCURONIUM BROMIDE
ANDA #091458		 SUPPL-11 ROCURONIUM BROMIDE SAGENT PHARMS INC Labeling Approval
07/26/2018 ATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #091488		 SUPPL-6 ATRACURIUM BESYLATE MEITHEAL Labeling Approval
07/26/2018 ATRACURIUM BESYLATE
ANDA #091489		 SUPPL-6 ATRACURIUM BESYLATE MEITHEAL Labeling Approval
07/26/2018 MONTELUKAST SODIUM
ANDA #200889		 SUPPL-10 MONTELUKAST SODIUM SANDOZ INC Labeling Approval
07/26/2018 GADAVIST
NDA #201277		 SUPPL-15 GADOBUTROL BAYER HLTHCARE Labeling Approval
07/26/2018 VECURONIUM BROMIDE
ANDA #205390		 SUPPL-2 VECURONIUM BROMIDE GLAND Labeling Approval
07/26/2018 ATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #206001		 SUPPL-2 ATRACURIUM BESYLATE PHARMOBEDIENT Labeling Approval
07/26/2018 ATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #206010		 SUPPL-3 ATRACURIUM BESYLATE EUGIA PHARMA Labeling Approval
07/26/2018 ATRACURIUM BESYLATE
ANDA #206096		 SUPPL-2 ATRACURIUM BESYLATE PHARMOBEDIENT Labeling Approval
07/26/2018 ROCURONIUM BROMIDE
ANDA #206206		 SUPPL-2 ROCURONIUM BROMIDE EUGIA PHARMA Labeling Approval
07/27/2018 CARDENE
NDA #019734		 SUPPL-30 NICARDIPINE HYDROCHLORIDE CHIESI Labeling Approval
07/27/2018 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-30 NICARDIPINE HYDROCHLORIDE CHIESI Labeling Approval
07/27/2018 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-30 NICARDIPINE HYDROCHLORIDE CHIESI Labeling Approval
07/27/2018 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-30 NICARDIPINE HYDROCHLORIDE CHIESI Labeling Approval
07/27/2018 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
NDA #019734		 SUPPL-30 NICARDIPINE HYDROCHLORIDE CHIESI Labeling Approval
07/27/2018 RISPERDAL
NDA #020272		 SUPPL-80 RISPERIDONE JANSSEN PHARMS Labeling Approval
07/27/2018 RISPERDAL
NDA #020588		 SUPPL-68 RISPERIDONE JANSSEN PHARMS Labeling Approval
07/27/2018 RISPERDAL CONSTA
NDA #021346		 SUPPL-58 RISPERIDONE JANSSEN PHARMS Labeling Approval
07/27/2018 RISPERDAL
NDA #021444		 SUPPL-54 RISPERIDONE JANSSEN PHARMS Labeling Approval
07/27/2018 INVEGA
NDA #021999		 SUPPL-35 PALIPERIDONE JANSSEN PHARMS Labeling Approval
07/27/2018 INVEGA SUSTENNA
NDA #022264		 SUPPL-27 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
07/27/2018 MONTELUKAST SODIUM
ANDA #091576		 SUPPL-14 MONTELUKAST SODIUM STRIDES PHARMA INTL Labeling Approval
07/27/2018 MONTELUKAST SODIUM
ANDA #091588		 SUPPL-14 MONTELUKAST SODIUM PHARMACO Labeling Approval
07/27/2018 INFLECTRA
BLA #125544		 SUPPL-8 INFLIXIMAB-DYYB CELLTRION INC Approval
07/27/2018 RASAGILINE MESYLATE
ANDA #201892		 ORIG-1 RASAGILINE MESYLATE CHARTWELL RX Approval
07/27/2018 XARELTO
NDA #202439		 SUPPL-23 RIVAROXABAN JANSSEN PHARMS Labeling Approval
07/27/2018 TYBOST
NDA #203094		 SUPPL-11 COBICISTAT GILEAD SCIENCES INC Labeling Approval
07/27/2018 NUDOVRA
ANDA #203307		 ORIG-1 ESTRADIOL VALERATE;ESTRADIOL VALERATE;DIENOGEST LUPIN LTD Tentative Approval
07/27/2018 HYDROCORTISONE
ANDA #203804		 ORIG-1 HYDROCORTISONE ENCUBE Approval
07/27/2018 DONEPEZIL HYDROCHLORIDE
ANDA #205269		 ORIG-1 DONEPEZIL HYDROCHLORIDE HISUN PHARM HANGZHOU Approval
07/27/2018 BIVALIRUDIN
ANDA #205962		 ORIG-1 BIVALIRUDIN EUGIA PHARMA Approval
07/27/2018 NITROGLYCERIN
ANDA #206391		 SUPPL-1 NITROGLYCERIN GLENMARK SPECLT Labeling Approval
07/27/2018 NITROGLYCERIN
ANDA #206391		 SUPPL-2 NITROGLYCERIN GLENMARK SPECLT Labeling Approval
07/27/2018 LEUCOVORIN CALCIUM
ANDA #207226		 ORIG-1 LEUCOVORIN CALCIUM FRESENIUS KABI USA Approval
07/27/2018 TOLVAPTAN
ANDA #207255		 ORIG-1 TOLVAPTAN JIANGSU HENGRUI MED Tentative Approval
07/27/2018 PIPERACILLIN AND TAZOBACTAM
ANDA #207847		 SUPPL-2 PIPERACILLIN SODIUM; TAZOBACTAM SODIUM MILLA PHARMS Labeling Approval
07/27/2018 INVEGA HAFYERA
NDA #207946		 SUPPL-6 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
07/27/2018 INVEGA TRINZA
NDA #207946		 SUPPL-6 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
07/27/2018 TERIFLUNOMIDE
ANDA #209549		 ORIG-1 TERIFLUNOMIDE WATSON LABS TEVA Approval
07/27/2018 OMEGAVEN
NDA #210589		 ORIG-1 FISH OIL TRIGLYCERIDES FRESENIUS KABI USA Type 1 - New Molecular Entity and Type 4 - New Combination Approval
07/27/2018 PERSERIS KIT
NDA #210655		 ORIG-1 RISPERIDONE INDIVIOR Type 3 - New Dosage Form Approval
07/27/2018 DICLOFENAC SODIUM
ANDA #210893		 ORIG-1 DICLOFENAC SODIUM PADAGIS ISRAEL Approval
07/30/2018 NITROLINGUAL
NDA #018705		 SUPPL-25 NITROGLYCERIN POHL BOSKAMP Labeling Approval
07/30/2018 NITROLINGUAL PUMPSPRAY
NDA #018705		 SUPPL-25 NITROGLYCERIN POHL BOSKAMP Labeling Approval
07/30/2018 IFEX
NDA #019763		 SUPPL-20 IFOSFAMIDE BAXTER HLTHCARE Labeling Approval
07/30/2018 IFEX/MESNEX KIT
NDA #019763		 SUPPL-20 IFOSFAMIDE; MESNA BAXTER HLTHCARE Labeling Approval
07/30/2018 REMODULIN
NDA #021272		 SUPPL-25 TREPROSTINIL UNITED THERAP Labeling Approval
07/30/2018 VIREAD
NDA #021356		 SUPPL-56 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
07/30/2018 XARELTO
NDA #022406		 SUPPL-28 RIVAROXABAN JANSSEN PHARMS Labeling Approval
07/30/2018 VIREAD
NDA #022577		 SUPPL-12 TENOFOVIR DISOPROXIL FUMARATE GILEAD SCIENCES INC Labeling Approval
07/30/2018 BENAZEPRIL HYDROCHLORIDE
ANDA #076820		 SUPPL-17 BENAZEPRIL HYDROCHLORIDE AMNEAL PHARMS Labeling Approval
07/30/2018 MONTELUKAST SODIUM
ANDA #202843		 SUPPL-2 MONTELUKAST SODIUM HETERO LABS LTD V Labeling Approval
07/30/2018 TEMSIROLIMUS
ANDA #203153		 ORIG-1 TEMSIROLIMUS ACCORD HLTHCARE Approval
07/30/2018 KERYDIN
NDA #204427		 SUPPL-6 TAVABOROLE ANACOR PHARMS INC Efficacy Approval
07/30/2018 JYNARQUE
NDA #204441		 SUPPL-1 TOLVAPTAN OTSUKA REMS Approval
07/30/2018 DALFAMPRIDINE
ANDA #206765		 ORIG-1 DALFAMPRIDINE ALKEM LABS LTD Approval
07/30/2018 BENDEKA
NDA #208194		 SUPPL-13 BENDAMUSTINE HYDROCHLORIDE EAGLE PHARMS Labeling Approval
07/30/2018 REMODULIN
NDA #208276		 ORIG-1 TREPROSTINIL UNITED THERAP Type 3 - New Dosage Form Approval
07/30/2018 GEMCITABINE HYDROCHLORIDE
NDA #209604		 SUPPL-3 GEMCITABINE HYDROCHLORIDE ACCORD HLTHCARE Labeling Approval
07/30/2018 AZEDRA
NDA #209607		 ORIG-1 IOBENGUANE I-131 PROGENICS PHARMS INC Type 5 - New Formulation or New Manufacturer Approval
07/31/2018 CLARITIN-D
NDA #019670		 SUPPL-34 LORATADINE; PSEUDOEPHEDRINE SULFATE BAYER HEALTHCARE LLC Labeling Approval
07/31/2018 CLARITIN-D 24 HOUR
NDA #020470		 SUPPL-47 LORATADINE; PSEUDOEPHEDRINE SULFATE BAYER HEALTHCARE LLC Labeling Approval
07/31/2018 CALCIUM CARBONATE; RISEDRONATE SODIUM
ANDA #090831		 ORIG-1 CALCIUM CARBONATE;RISEDRONATE SODIUM APOTEX INC Tentative Approval
07/31/2018 GRANIX
BLA #125294		 SUPPL-45 TBO-FILGRASTIM SICOR BIOTECH Approval
07/31/2018 BUSULFAN
ANDA #205672		 ORIG-1 BUSULFAN HOSPIRA Approval
07/31/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #206481		 ORIG-1 TENOFOVIR DISOPROXIL FUMARATE CHARTWELL Approval
07/31/2018 MONTELUKAST SODIUM
ANDA #210431		 ORIG-1 MONTELUKAST SODIUM TORRENT Approval
07/31/2018 MULPLETA
NDA #210923		 ORIG-1 LUSUTROMBOPAG VANCOCIN ITALIA Type 1 - New Molecular Entity Approval
07/31/2018 AZITHROMYCIN
ANDA #211147		 ORIG-1 AZITHROMYCIN ZYDUS LIFESCIENCES Approval
Back to Top