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 December 15, 2019.

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 ANDA REPOSITORY 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 WILSHIRE PHARMS INC 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 TICAGRELOR
ANDA #208576
ORIG-1 TICAGRELOR ALEMBIC PHARMS LTD Tentative Approval
07/02/2018 MONTELUKAST SODIUM
ANDA #208621
ORIG-1 MONTELUKAST SODIUM UNICHEM LABS LTD Approval
07/02/2018 CAPECITABINE
ANDA #209365
ORIG-1 CAPECITABINE MSN LABS PVT LTD 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 WYETH PHARMS Labeling Approval
07/03/2018 ARRANON
NDA #021877
SUPPL-8 NELARABINE NOVARTIS Labeling Approval
07/03/2018 ARGATROBAN IN SODIUM CHLORIDE
NDA #022485
SUPPL-11 ARGATROBAN SANDOZ Labeling Approval
07/03/2018 Xeomin
BLA #125360
SUPPL-73 incobotulinumtoxinA MERZ PHARMS Approval
07/03/2018 LEVONORGESTREL
ANDA #204044
ORIG-1 LEVONORGESTREL AMNEAL PHARMS 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 INC 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 DEFERASIROX
ANDA #208882
ORIG-1 DEFERASIROX ZYDUS PHARMS USA INC Tentative 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 PHARMS Labeling Approval
07/06/2018 HYDROXYCHLOROQUINE SULFATE
ANDA #210543
ORIG-1 HYDROXYCHLOROQUINE SULFATE LUPIN LTD 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 BRECKENRIDGE Approval
07/09/2018 CLARITHROMYCIN
ANDA #208987
ORIG-1 CLARITHROMYCIN SUNSHINE LAKE Approval
07/09/2018 HYDRALAZINE HYDROCHLORIDE
ANDA #209251
ORIG-1 HYDRALAZINE HYDROCHLORIDE UPSHER SMITH LABS 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 LIFE MOLECULAR 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 LACOSAMIDE
ANDA #209224
ORIG-1 LACOSAMIDE AUROBINDO PHARMA LTD Tentative Approval
07/10/2018 VANCOMYCIN HYDROCHLORIDE
NDA #209481
ORIG-1 VANCOMYCIN HYDROCHLORIDE MYLAN LABS LTD Type 5 - New Formulation or New Manufacturer Approval
07/10/2018 AZELAIC ACID
ANDA #210928
ORIG-1 AZELAIC ACID TEVA PHARMS USA INC Tentative 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 APOTEX INC Approval
07/11/2018 NAFCILLIN SODIUM
ANDA #091613
SUPPL-4 NAFCILLIN SODIUM AUROBINDO PHARMA LTD 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 CABAZITAXEL
ANDA #207736
ORIG-1 CABAZITAXEL APOTEX INC Tentative Approval
07/11/2018 MESALAMINE
ANDA #209970
ORIG-1 MESALAMINE TEVA PHARMS USA INC Tentative Approval
07/11/2018 GLYRX-PF
NDA #210997
ORIG-1 GLYCOPYRROLATE EXELA PHARMA SCS LLC Type 5 - New Formulation or New Manufacturer Approval
07/11/2018 GLYRX-PF
NDA #210997
ORIG-2 GLYCOPYRROLATE EXELA PHARMA SCS LLC 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 SPECIALITY 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 BORTEZOMIB
NDA #209191
ORIG-1 BORTEZOMIB HOSPIRA INC Type 5 - New Formulation or New Manufacturer Approval
07/12/2018 OMEPRAZOLE
NDA #209400
SUPPL-3 OMEPRAZOLE DEXCEL PHARMA 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 PHARMACIA AND 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 MYLAN LABS LTD 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 MYLAN 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 SCS LLC 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 VALEANT PHARMS LLC Labeling Approval
07/16/2018 ADDERALL XR 10
NDA #021303
SUPPL-29 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SHIRE Labeling Approval
07/16/2018 ADDERALL XR 15
NDA #021303
SUPPL-29 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SHIRE Labeling Approval
07/16/2018 ADDERALL XR 20
NDA #021303
SUPPL-29 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SHIRE Labeling Approval
07/16/2018 ADDERALL XR 25
NDA #021303
SUPPL-29 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SHIRE Labeling Approval
07/16/2018 ADDERALL XR 30
NDA #021303
SUPPL-29 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SHIRE Labeling Approval
07/16/2018 ADDERALL XR 5
NDA #021303
SUPPL-29 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE SHIRE 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 CIPLA 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 CAPELLON PHARMS LLC 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 CADILA 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 LTD 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 CADILA 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
NDA #019774
SUPPL-48 SOMATROPIN FERRING Efficacy Approval
07/19/2018 BIO-TROPIN
NDA #019774
SUPPL-49 SOMATROPIN FERRING Efficacy Approval
07/19/2018 BIO-TROPIN
NDA #019774
SUPPL-50 SOMATROPIN FERRING Efficacy Approval
07/19/2018 BIO-TROPIN
NDA #019774
SUPPL-51 SOMATROPIN FERRING Efficacy Approval
07/19/2018 ZOMACTON
NDA #019774
SUPPL-48 SOMATROPIN FERRING Efficacy Approval
07/19/2018 ZOMACTON
NDA #019774
SUPPL-49 SOMATROPIN FERRING Efficacy Approval
07/19/2018 ZOMACTON
NDA #019774
SUPPL-50 SOMATROPIN FERRING Efficacy Approval
07/19/2018 ZOMACTON
NDA #019774
SUPPL-51 SOMATROPIN FERRING Efficacy 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 PHARMS LLC Approval
07/19/2018 POTASSIUM CHLORIDE
ANDA #210041
ORIG-1 POTASSIUM CHLORIDE AMNEAL PHARMS LLC 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 CELGENE Labeling Approval
07/20/2018 PRALUENT
BLA #125559
SUPPL-15 ALIROCUMAB SANOFI AVENTIS 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 AJANTA PHARMA LTD Manufacturing (CMC) Approval
07/20/2018 CABAZITAXEL
ANDA #207619
ORIG-1 CABAZITAXEL BRECKENRIDGE PHARM Tentative Approval
07/20/2018 ACETYLCYSTEINE
ANDA #208166
ORIG-1 ACETYLCYSTEINE ZYDUS PHARMS Approval
07/20/2018 TICAGRELOR
ANDA #208508
ORIG-1 TICAGRELOR HEC Pharm USA, Inc. Tentative 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 ELYSIUM Approval
07/20/2018 TIBSOVO
NDA #211192
ORIG-1 IVOSIDENIB AGIOS PHARMS INC Type 1 - New Molecular Entity Approval
07/20/2018 NIVESTYM
BLA #761080
ORIG-1 FILGRASTIM-AAFI HOSPIRA INC Approval
07/22/2018 FIASP
NDA #208751
SUPPL-2 INSULIN ASPART NOVO Manufacturing (CMC) Approval
07/22/2018 FIASP FLEXTOUCH
NDA #208751
SUPPL-2 INSULIN ASPART NOVO Manufacturing (CMC) Approval
07/22/2018 FIASP PENFILL
NDA #208751
SUPPL-2 INSULIN ASPART NOVO Manufacturing (CMC) 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 LANNETT CO INC 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 TELIGENT PHARMA INC Approval
07/23/2018 PIROXICAM
ANDA #206136
SUPPL-3 PIROXICAM BRECKENRIDGE 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 INC Labeling Approval
07/23/2018 TECHNIVIE
NDA #207931
SUPPL-12 OMBITASVIR; PARITAPREVIR; RITONAVIR ABBVIE INC 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 INC 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 INC Type 1 - New Molecular Entity Approval
07/23/2018 NADOLOL
ANDA #210955
ORIG-1 NADOLOL BEXIMCO PHARMS USA Approval
07/24/2018 MEDROL
NDA #011153
SUPPL-75 METHYLPREDNISOLONE PHARMACIA AND UPJOHN Labeling Approval
07/24/2018 DEPO-MEDROL
NDA #011757
SUPPL-114 METHYLPREDNISOLONE ACETATE PHARMACIA AND UPJOHN 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 ALLERGAN 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 LTD 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 MYLAN 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 AUROBINDO PHARMA LTD Approval
07/24/2018 DOXERCALCIFEROL
NDA #208614
ORIG-1 DOXERCALCIFEROL HOSPIRA INC 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 INC 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 TEVA PHARMS USA Labeling Approval
07/26/2018 ATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #074900
SUPPL-20 ATRACURIUM BESYLATE WEST-WARD PHARMS INT Labeling Approval
07/26/2018 ATRACURIUM BESYLATE
ANDA #074901
SUPPL-20 ATRACURIUM BESYLATE WEST-WARD PHARMS INT 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 WEST-WARD PHARMS INT Labeling Approval
07/26/2018 VECURONIUM BROMIDE
ANDA #075549
SUPPL-13 VECURONIUM BROMIDE WEST-WARD PHARMS INT 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 INC 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 SANDOZ 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 PHARMA LTD Labeling Approval
07/26/2018 ATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #206001
SUPPL-2 ATRACURIUM BESYLATE MYLAN LABS LTD Labeling Approval
07/26/2018 ATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #206010
SUPPL-3 ATRACURIUM BESYLATE AUROBINDO PHARMA LTD Labeling Approval
07/26/2018 ATRACURIUM BESYLATE
ANDA #206096
SUPPL-2 ATRACURIUM BESYLATE MYLAN LABS LTD Labeling Approval
07/26/2018 ROCURONIUM BROMIDE
ANDA #206206
SUPPL-2 ROCURONIUM BROMIDE AUROBINDO PHARMA LTD Labeling Approval
07/27/2018 CARDENE
NDA #019734
SUPPL-30 NICARDIPINE HYDROCHLORIDE CHIESI USA INC Labeling Approval
07/27/2018 CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734
SUPPL-30 NICARDIPINE HYDROCHLORIDE CHIESI USA INC Labeling Approval
07/27/2018 CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734
SUPPL-30 NICARDIPINE HYDROCHLORIDE CHIESI USA INC Labeling Approval
07/27/2018 CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
NDA #019734
SUPPL-30 NICARDIPINE HYDROCHLORIDE CHIESI USA INC Labeling Approval
07/27/2018 CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
NDA #019734
SUPPL-30 NICARDIPINE HYDROCHLORIDE CHIESI USA INC 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 VINTAGE PHARMS LLC Labeling Approval
07/27/2018 MONTELUKAST SODIUM
ANDA #091588
SUPPL-14 MONTELUKAST SODIUM VINTAGE PHARMS LLC 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 SANDOZ INC 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 TELIGENT PHARMA INC 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 AUROBINDO PHARMA LTD Approval
07/27/2018 NITROGLYCERIN
ANDA #206391
SUPPL-1 NITROGLYCERIN GLENMARK PHARMS SA Labeling Approval
07/27/2018 NITROGLYCERIN
ANDA #206391
SUPPL-2 NITROGLYCERIN GLENMARK PHARMS SA 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 APOLLO PHARMS INC Labeling Approval
07/27/2018 INVEGA TRINZA
NDA #207946
SUPPL-6 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
07/27/2018 ROFLUMILAST
ANDA #208299
ORIG-1 ROFLUMILAST PRINSTON PHARMA INC Tentative 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 INC Type 3 - New Dosage Form Approval
07/27/2018 DICLOFENAC SODIUM
ANDA #210893
ORIG-1 DICLOFENAC SODIUM PERRIGO UK FINCO 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 PHARM CO LTD 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 INC Approval
07/31/2018 IMIQUIMOD
ANDA #205971
ORIG-1 IMIQUIMOD TARO PHARM INDS LTD Tentative Approval
07/31/2018 TENOFOVIR DISOPROXIL FUMARATE
ANDA #206481
ORIG-1 TENOFOVIR DISOPROXIL FUMARATE CHARTWELL Approval
07/31/2018 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
ANDA #208757
ORIG-1 BENZOYL PEROXIDE;CLINDAMYCIN PHOSPHATE ACTAVIS LABS UT INC Tentative Approval
07/31/2018 MONTELUKAST SODIUM
ANDA #210431
ORIG-1 MONTELUKAST SODIUM TORRENT Approval
07/31/2018 MULPLETA
NDA #210923
ORIG-1 LUSUTROMBOPAG SHIONOGI INC Type 1 - New Molecular Entity Approval
07/31/2018 AZITHROMYCIN
ANDA #211147
ORIG-1 AZITHROMYCIN ZYDUS Approval

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English