Drugs@FDA: FDA Approved Drug Products

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All Approvals
January 2019

This report lists both original approvals and supplemental approvals to NDAs, ANDAs, and BLAs* during the selected month. It includes tentative approvals and original approvals. Supplemental approvals may have occurred after the selected month. This page shows current information for the products listed.

Click on the Application Number to see all drug details, including the full approval history. *Not all biologics are in Drugs@FDA.

This report was produced on February 22, 2019.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
01/02/2019 HABITROL
NDA #020076
SUPPL-51 NICOTINE DR REDDYS LABS SA Labeling Approval
01/02/2019 METFORMIN HYDROCHLORIDE
ANDA #079118
SUPPL-8 METFORMIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
01/02/2019 METFORMIN HYDROCHLORIDE
ANDA #079118
SUPPL-9 METFORMIN HYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
01/02/2019 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #204518
ORIG-1 PRAMIPEXOLE DIHYDROCHLORIDE ALEMBIC PHARMS LTD Approval
01/02/2019 TERIFLUNOMIDE
ANDA #209697
ORIG-1 TERIFLUNOMIDE TORRENT PHARMA INC Tentative Approval
01/02/2019 DALFAMPRIDINE
ANDA #210158
ORIG-1 DALFAMPRIDINE MICRO LABS LTD Tentative Approval
01/03/2019 ALEVE
NDA #020204
SUPPL-62 NAPROXEN SODIUM BAYER Labeling Approval
01/03/2019 XOPENEX
NDA #020837
SUPPL-44 LEVALBUTEROL HYDROCHLORIDE OAK PHARMS INC Labeling Approval
01/03/2019 MUCINEX DM
NDA #021620
SUPPL-39 DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN RB HLTH Manufacturing (CMC) Approval
01/03/2019 CHILDREN'S CLARITIN
NDA #021891
SUPPL-28 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
01/03/2019 CLARITIN
NDA #021891
SUPPL-28 LORATADINE BAYER HEALTHCARE LLC Labeling Approval
01/03/2019 METHOTREXATE SODIUM
ANDA #081235
SUPPL-29 METHOTREXATE SODIUM MYLAN Labeling Approval
01/03/2019 ONCASPAR
BLA #103411
SUPPL-5196 PEGASPARGASE SIGMA TAU Approval
01/03/2019 LURASIDONE HYDROCHLORIDE
ANDA #208002
ORIG-1 LURASIDONE HYDROCHLORIDE AMNEAL PHARMS CO Approval
01/03/2019 LURASIDONE HYDROCHLORIDE
ANDA #208028
ORIG-1 LURASIDONE HYDROCHLORIDE INVAGEN PHARMS Approval
01/03/2019 LURASIDONE HYDROCHLORIDE
ANDA #208031
ORIG-1 LURASIDONE HYDROCHLORIDE LUPIN LTD Approval
01/03/2019 LURASIDONE HYDROCHLORIDE
ANDA #208049
ORIG-1 LURASIDONE HYDROCHLORIDE ACCORD HLTHCARE Approval
01/03/2019 LURASIDONE HYDROCHLORIDE
ANDA #208055
ORIG-1 LURASIDONE HYDROCHLORIDE TORRENT PHARMS LTD Approval
01/03/2019 TERIFLUNOMIDE
ANDA #209710
ORIG-1 TERIFLUNOMIDE SANDOZ INC Approval
01/03/2019 METHADONE HYDROCHLORIDE
ANDA #211228
ORIG-1 METHADONE HYDROCHLORIDE ASCENT PHARMS INC Approval
01/04/2019 TRILEPTAL
NDA #021014
SUPPL-43 OXCARBAZEPINE NOVARTIS Labeling Approval
01/04/2019 TRILEPTAL
NDA #021285
SUPPL-36 OXCARBAZEPINE NOVARTIS Labeling Approval
01/04/2019 PLAN B ONE-STEP
NDA #021998
SUPPL-6 LEVONORGESTREL FDN CONSUMER Labeling Approval
01/04/2019 ESTRADIOL
ANDA #040275
SUPPL-10 ESTRADIOL EPIC PHARMA INC Labeling Approval
01/04/2019 TAPAZOLE
ANDA #040320
SUPPL-8 METHIMAZOLE KING PHARMS LLC Labeling Approval
01/04/2019 ESTRADIOL
ANDA #040326
SUPPL-14 ESTRADIOL MYLAN Labeling Approval
01/04/2019 ZIDOVUDINE
ANDA #078349
SUPPL-22 ZIDOVUDINE CIPLA LTD Labeling Approval
01/04/2019 ZIDOVUDINE
ANDA #078349
SUPPL-23 ZIDOVUDINE CIPLA LTD Labeling Approval
01/04/2019 TYSABRI
BLA #125104
SUPPL-965 NATALIZUMAB BIOGEN IDEC Approval
01/04/2019 NAPROXEN SODIUM
ANDA #202807
ORIG-1 NAPROXEN SODIUM CATALENT Approval
01/04/2019 GLYBURIDE
ANDA #203379
ORIG-1 GLYBURIDE CADILA PHARMS LTD Approval
01/04/2019 ROCURONIUM BROMIDE
ANDA #204679
SUPPL-1 ROCURONIUM BROMIDE WEST WARD PHARM CORP Labeling Approval
01/04/2019 PREGABALIN
ANDA #206942
ORIG-1 PREGABALIN TORRENT PHARMS LTD Tentative Approval
01/04/2019 LURASIDONE HYDROCHLORIDE
ANDA #208066
ORIG-1 LURASIDONE HYDROCHLORIDE SUN PHARMA GLOBAL Approval
01/04/2019 APIXABAN
ANDA #210156
ORIG-1 APIXABAN TORRENT PHARMS LLC Tentative Approval
01/04/2019 PROPAFENONE HYDROCHLORIDE
ANDA #210339
ORIG-1 PROPAFENONE HYDROCHLORIDE SINOTHERAPEUTICS INC Approval
01/04/2019 FEBUXOSTAT
ANDA #210461
ORIG-1 FEBUXOSTAT MSN LABORATORIES Tentative Approval
01/04/2019 DAPAGLIFLOZIN ACETATE
ANDA #211442
ORIG-1 DAPAGLIFLOZIN ACETATE APOTEX INC Tentative Approval
01/05/2019 PLAQUENIL
NDA #009768
SUPPL-51 HYDROXYCHLOROQUINE SULFATE CONCORDIA PHARMS INC Manufacturing (CMC) Approval
01/05/2019 COLY-MYCIN S
NDA #050356
SUPPL-59 COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE ENDO PHARMS INC Labeling Approval
01/07/2019 LOTENSIN
NDA #019851
SUPPL-54 BENAZEPRIL HYDROCHLORIDE US PHARMS HOLDINGS I Labeling Approval
01/07/2019 FLONASE
NDA #020121
SUPPL-45 FLUTICASONE PROPIONATE GLAXOSMITHKLINE Labeling Approval
01/07/2019 FLOVENT DISKUS 100
NDA #020833
SUPPL-34 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
01/07/2019 FLOVENT DISKUS 250
NDA #020833
SUPPL-34 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
01/07/2019 FLOVENT DISKUS 50
NDA #020833
SUPPL-34 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
01/07/2019 ADVAIR DISKUS 100/50
NDA #021077
SUPPL-61 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
01/07/2019 ADVAIR DISKUS 250/50
NDA #021077
SUPPL-61 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
01/07/2019 ADVAIR DISKUS 500/50
NDA #021077
SUPPL-61 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
01/07/2019 ADVAIR HFA
NDA #021254
SUPPL-28 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE GLAXO GRP LTD Labeling Approval
01/07/2019 FLOVENT HFA
NDA #021433
SUPPL-34 FLUTICASONE PROPIONATE GLAXO GRP LTD Labeling Approval
01/07/2019 ARIPIPRAZOLE
ANDA #090472
ORIG-1 ARIPIPRAZOLE ZYDUS PHARMS USA INC Approval
01/07/2019 CERINTA
ANDA #202817
ORIG-1 ETHINYL ESTRADIOL; LEVONORGESTREL SUN PHARM INDS LTD Approval
01/07/2019 BREO ELLIPTA
NDA #204275
SUPPL-17 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE GLAXO GRP LTD Labeling Approval
01/07/2019 ARNUITY ELLIPTA
NDA #205625
SUPPL-7 FLUTICASONE FUROATE GLAXOSMITHKLINE Labeling Approval
01/07/2019 LINEZOLID
ANDA #206097
SUPPL-1 LINEZOLID ZYDUS PHARMS USA INC Labeling Approval
01/07/2019 LINEZOLID
ANDA #206097
SUPPL-2 LINEZOLID ZYDUS PHARMS USA INC Labeling Approval
01/07/2019 ABIRATERONE ACETATE
ANDA #208327
ORIG-1 ABIRATERONE ACETATE AMNEAL PHARMS Approval
01/07/2019 INGENOL MEBUTATE
ANDA #209018
ORIG-1 INGENOL MEBUTATE PERRIGO UK FINCO Approval
01/07/2019 TRELEGY ELLIPTA
NDA #209482
SUPPL-2 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE GLAXOSMITHKLINE Labeling Approval
01/07/2019 TRELEGY ELLIPTA
NDA #209482
SUPPL-3 FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE GLAXOSMITHKLINE Labeling Approval
01/07/2019 TERIFLUNOMIDE
ANDA #209690
ORIG-1 TERIFLUNOMIDE ACCORD HLTHCARE Approval
01/08/2019 BILTRICIDE
NDA #018714
SUPPL-18 PRAZIQUANTEL BAYER HLTHCARE Labeling Approval
01/08/2019 DOCEFREZ
NDA #022534
SUPPL-7 DOCETAXEL SUN PHARMA GLOBAL Efficacy Approval
01/08/2019 DOCETAXEL
NDA #022534
SUPPL-7 DOCETAXEL SUN PHARMA GLOBAL Efficacy Approval
01/08/2019 ZIDOVUDINE
ANDA #077981
SUPPL-26 ZIDOVUDINE CIPLA LTD Labeling Approval
01/08/2019 ZIDOVUDINE
ANDA #077981
SUPPL-27 ZIDOVUDINE CIPLA LTD Labeling Approval
01/08/2019 ZIDOVUDINE
ANDA #077981
SUPPL-28 ZIDOVUDINE CIPLA LTD Labeling Approval
01/08/2019 PEGINTRON
BLA #103949
SUPPL-5313 PEGINTERFERON ALFA-2B SCHERING Approval
01/08/2019 SYLATRON
BLA #103949
SUPPL-5313 PEGINTERFERON ALFA-2B SCHERING Approval
01/08/2019 RIVASTIGMINE
ANDA #207308
ORIG-1 RIVASTIGMINE AMNEAL PHARMS Approval
01/08/2019 MYCOPHENOLATE MOFETIL
ANDA #210181
ORIG-1 MYCOPHENOLATE MOFETIL CONCORD BIOTECH LTD Approval
01/09/2019 MANNITOL 10%
NDA #016269
SUPPL-55 MANNITOL HOSPIRA Labeling Approval
01/09/2019 MANNITOL 15%
NDA #016269
SUPPL-55 MANNITOL HOSPIRA Labeling Approval
01/09/2019 MANNITOL 20%
NDA #016269
SUPPL-55 MANNITOL HOSPIRA Labeling Approval
01/09/2019 MANNITOL 25%
NDA #016269
SUPPL-55 MANNITOL HOSPIRA Labeling Approval
01/09/2019 MANNITOL 5%
NDA #016269
SUPPL-55 MANNITOL HOSPIRA Labeling Approval
01/09/2019 MANNITOL 10% IN PLASTIC CONTAINER
NDA #019603
SUPPL-38 MANNITOL ICU MEDICAL INC Labeling Approval
01/09/2019 MANNITOL 15% IN PLASTIC CONTAINER
NDA #019603
SUPPL-38 MANNITOL ICU MEDICAL INC Labeling Approval
01/09/2019 MANNITOL 20% IN PLASTIC CONTAINER
NDA #019603
SUPPL-38 MANNITOL ICU MEDICAL INC Labeling Approval
01/09/2019 MANNITOL 5% IN PLASTIC CONTAINER
NDA #019603
SUPPL-38 MANNITOL ICU MEDICAL INC Labeling Approval
01/09/2019 MANNITOL 10% IN PLASTIC CONTAINER
NDA #020006
SUPPL-25 MANNITOL B BRAUN Labeling Approval
01/09/2019 MANNITOL 15% IN PLASTIC CONTAINER
NDA #020006
SUPPL-25 MANNITOL B BRAUN Labeling Approval
01/09/2019 MANNITOL 20% IN PLASTIC CONTAINER
NDA #020006
SUPPL-25 MANNITOL B BRAUN Labeling Approval
01/09/2019 MANNITOL 5% IN PLASTIC CONTAINER
NDA #020006
SUPPL-25 MANNITOL B BRAUN Labeling Approval
01/09/2019 NATRECOR
NDA #020920
SUPPL-36 NESIRITIDE RECOMBINANT SCIOS LLC Labeling Approval
01/09/2019 VIMPAT
NDA #022253
SUPPL-41 LACOSAMIDE UCB INC Efficacy Approval
01/09/2019 VIMPAT
NDA #022254
SUPPL-32 LACOSAMIDE UCB INC Efficacy Approval
01/09/2019 VIMPAT
NDA #022255
SUPPL-23 LACOSAMIDE UCB INC Efficacy Approval
01/09/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090199
SUPPL-12 LEVOCETIRIZINE DIHYDROCHLORIDE TEVA PHARMS Labeling Approval
01/09/2019 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #090199
SUPPL-13 LEVOCETIRIZINE DIHYDROCHLORIDE TEVA PHARMS Labeling Approval
01/09/2019 PROAIR DIGIHALER
NDA #205636
SUPPL-12 ALBUTEROL SULFATE TEVA BRANDED PHARM Labeling Approval
01/09/2019 PROAIR RESPICLICK
NDA #205636
SUPPL-12 ALBUTEROL SULFATE TEVA BRANDED PHARM Labeling Approval
01/09/2019 OLOPATADINE HYDROCHLORIDE
ANDA #209015
ORIG-1 OLOPATADINE HYDROCHLORIDE APOTEX INC Tentative Approval
01/09/2019 INGENOL MEBUTATE
ANDA #209019
ORIG-1 INGENOL MEBUTATE PERRIGO UK FINCO Approval
01/09/2019 PREGABALIN
ANDA #209357
ORIG-1 PREGABALIN MSN LABORATORIES Tentative Approval
01/09/2019 METHYLPREDNISOLONE
ANDA #210985
ORIG-1 METHYLPREDNISOLONE RICONPHARMA LLC Approval
01/09/2019 CINQAIR
BLA #761033
SUPPL-10 RESLIZUMAB TEVA RESPIRATORY LLC Approval
01/10/2019 RITALIN
NDA #010187
SUPPL-71 METHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
01/10/2019 RITALIN
NDA #010187
SUPPL-82 METHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
01/10/2019 RITALIN-SR
NDA #018029
SUPPL-41 METHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
01/10/2019 RITALIN-SR
NDA #018029
SUPPL-51 METHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
01/10/2019 FOCALIN
NDA #021278
SUPPL-11 DEXMETHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
01/10/2019 FOCALIN
NDA #021278
SUPPL-19 DEXMETHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
01/10/2019 RITALIN LA
NDA #021284
SUPPL-16 METHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
01/10/2019 RITALIN LA
NDA #021284
SUPPL-29 METHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
01/10/2019 FOCALIN XR
NDA #021802
SUPPL-19 DEXMETHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
01/10/2019 FOCALIN XR
NDA #021802
SUPPL-29 DEXMETHYLPHENIDATE HYDROCHLORIDE NOVARTIS Labeling Approval
01/10/2019 OLOPATADINE HYDROCHLORIDE
ANDA #209015
SUPPL-1 OLOPATADINE HYDROCHLORIDE APOTEX INC Tentative Approval
01/10/2019 INGREZZA
NDA #209241
SUPPL-6 VALBENAZINE TOSYLATE NEUROCRINE Manufacturing (CMC) Approval
01/10/2019 OLMESARTAN MEDOXOMIL
ANDA #210552
ORIG-1 OLMESARTAN MEDOXOMIL QILU PHARM CO LTD Approval
01/10/2019 FLUOXETINE HYDROCHLORIDE
ANDA #211282
ORIG-1 FLUOXETINE HYDROCHLORIDE SCIEGEN PHARMS INC Approval
01/11/2019 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #017648
SUPPL-71 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
01/11/2019 POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #017648
SUPPL-71 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
01/11/2019 POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%
NDA #017648
SUPPL-71 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
01/11/2019 POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #017648
SUPPL-71 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
01/11/2019 SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
NDA #017648
SUPPL-71 POTASSIUM CHLORIDE; SODIUM CHLORIDE BAXTER HLTHCARE Labeling Approval
01/11/2019 CELEXA
NDA #020822
SUPPL-51 CITALOPRAM HYDROBROMIDE ALLERGAN SALES LLC Labeling Approval
01/11/2019 LEXAPRO
NDA #021323
SUPPL-51 ESCITALOPRAM OXALATE ALLERGAN SALES LLC Labeling Approval
01/11/2019 LEXAPRO
NDA #021365
SUPPL-36 ESCITALOPRAM OXALATE ALLERGAN SALES LLC Labeling Approval
01/11/2019 XYZAL
NDA #022064
SUPPL-37 LEVOCETIRIZINE DIHYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
01/11/2019 XYZAL
NDA #022157
SUPPL-19 LEVOCETIRIZINE DIHYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
01/11/2019 GILENYA
NDA #022527
SUPPL-26 FINGOLIMOD HYDROCHLORIDE NOVARTIS Labeling Approval
01/11/2019 LISINOPRIL
ANDA #075994
SUPPL-53 LISINOPRIL CASI PHARMS INC Labeling Approval
01/11/2019 LISINOPRIL
ANDA #075994
SUPPL-56 LISINOPRIL CASI PHARMS INC Labeling Approval
01/11/2019 HUMIRA
BLA #125057
SUPPL-411 ADALIMUMAB ABBVIE INC Approval
01/11/2019 MYCOPHENOLATE MOFETIL
ANDA #203005
SUPPL-4 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
01/11/2019 MYCOPHENOLATE MOFETIL
ANDA #203005
SUPPL-6 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
01/11/2019 MYCOPHENOLATE MOFETIL
ANDA #203005
SUPPL-7 MYCOPHENOLATE MOFETIL ALKEM LABS LTD Labeling Approval
01/11/2019 NALBUPHINE HYDROCHLORIDE
ANDA #207595
ORIG-1 NALBUPHINE HYDROCHLORIDE MYLAN LABS LTD Approval
01/11/2019 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
ANDA #207762
ORIG-1 AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM ZYDUS PHARMS USA INC Approval
01/11/2019 BETAMETHASONE DIPROPIONATE
ANDA #208885
ORIG-1 BETAMETHASONE DIPROPIONATE ZYDUS PHARMS USA INC Approval
01/11/2019 ACYCLOVIR
ANDA #209971
ORIG-1 ACYCLOVIR TORRENT PHARMS LTD Approval
01/11/2019 CLOBETASOL PROPIONATE
ANDA #211401
ORIG-1 CLOBETASOL PROPIONATE SOLARIS PHARMA CORP Approval
01/11/2019 LETROZOLE
ANDA #211717
ORIG-1 LETROZOLE EUGIA PHARMA Approval
01/14/2019 METFORMIN HYDROCHLORIDE
ANDA #075973
SUPPL-19 METFORMIN HYDROCHLORIDE MYLAN Labeling Approval
01/14/2019 METFORMIN HYDROCHLORIDE
ANDA #075973
SUPPL-20 METFORMIN HYDROCHLORIDE MYLAN Labeling Approval
01/14/2019 PIOGLITAZONE HYDROCHLORIDE
ANDA #078670
SUPPL-4 PIOGLITAZONE HYDROCHLORIDE SANDOZ Labeling Approval
01/14/2019 PIOGLITAZONE HYDROCHLORIDE
ANDA #078670
SUPPL-5 PIOGLITAZONE HYDROCHLORIDE SANDOZ Labeling Approval
01/14/2019 NEVIRAPINE
ANDA #090688
ORIG-1 NEVIRAPINE MACLEODS PHARMS LTD Approval
01/14/2019 HYDROCHLOROTHIAZIDE
ANDA #203561
ORIG-1 HYDROCHLOROTHIAZIDE SCIEGEN PHARMS INC Approval
01/14/2019 BUSULFAN
ANDA #207794
ORIG-1 BUSULFAN NEXUS PHARMS Approval
01/14/2019 CABOMETYX
NDA #208692
SUPPL-3 CABOZANTINIB S-MALATE EXELIXIS INC Efficacy Approval
01/14/2019 ALOSETRON HYDROCHLORIDE
ANDA #209180
ORIG-1 ALOSETRON HYDROCHLORIDE RISING PHARMS Approval
01/14/2019 METFORMIN HYDROCHLORIDE
ANDA #209313
SUPPL-1 METFORMIN HYDROCHLORIDE GRANULES INDIA LTD Labeling Approval
01/14/2019 VIGABATRIN
ANDA #209822
ORIG-1 VIGABATRIN TEVA PHARMS USA Approval
01/15/2019 DEXEDRINE
NDA #017078
SUPPL-52 DEXTROAMPHETAMINE SULFATE IMPAX LABS INC Labeling Approval
01/15/2019 ZEGERID OTC
NDA #022281
SUPPL-13 OMEPRAZOLE; SODIUM BICARBONATE BAYER HEALTHCARE LLC Labeling Approval
01/15/2019 ZEGERID OTC
NDA #022283
SUPPL-3 OMEPRAZOLE; SODIUM BICARBONATE BAYER HEALTHCARE LLC Labeling Approval
01/15/2019 XARELTO
NDA #022406
SUPPL-30 RIVAROXABAN JANSSEN PHARMS Labeling Approval
01/15/2019 XARELTO
NDA #022406
SUPPL-32 RIVAROXABAN JANSSEN PHARMS Labeling Approval
01/15/2019 CYTARABINE
ANDA #071868
SUPPL-29 CYTARABINE HOSPIRA Labeling Approval
01/15/2019 CYTARABINE
ANDA #071868
SUPPL-30 CYTARABINE HOSPIRA Labeling Approval
01/15/2019 CYTARABINE
ANDA #071868
SUPPL-31 CYTARABINE HOSPIRA Labeling Approval
01/15/2019 CYTARABINE
ANDA #072168
SUPPL-28 CYTARABINE HOSPIRA Labeling Approval
01/15/2019 CYTARABINE
ANDA #072168
SUPPL-29 CYTARABINE HOSPIRA Labeling Approval
01/15/2019 CYTARABINE
ANDA #072945
SUPPL-24 CYTARABINE HOSPIRA Labeling Approval
01/15/2019 SUDAFED 12 HOUR
ANDA #073585
SUPPL-20 PSEUDOEPHEDRINE HYDROCHLORIDE MCNEIL CONS Labeling Approval
01/15/2019 CYTARABINE
ANDA #075383
SUPPL-17 CYTARABINE HOSPIRA Labeling Approval
01/15/2019 ALENDRONATE SODIUM
ANDA #076768
SUPPL-7 ALENDRONATE SODIUM CIPLA Labeling Approval
01/15/2019 POLOCAINE
ANDA #088653
SUPPL-12 MEPIVACAINE HYDROCHLORIDE DENTSPLY PHARM Labeling Approval
01/15/2019 POLOCAINE W/ LEVONORDEFRIN
ANDA #089517
SUPPL-6 LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE DENTSPLY PHARM Labeling Approval
01/15/2019 TRULICITY
BLA #125469
SUPPL-23 DULAGLUTIDE ELI LILLY AND CO Approval
01/15/2019 RUFINAMIDE
ANDA #207363
ORIG-1 RUFINAMIDE WEST-WARD PHARMS INT Tentative Approval
01/15/2019 ELETRIPTAN HYDROBROMIDE
ANDA #210708
ORIG-1 ELETRIPTAN HYDROBROMIDE AUROBINDO PHARMA LTD Approval
01/15/2019 HYDROXYCHLOROQUINE SULFATE
ANDA #210959
ORIG-1 HYDROXYCHLOROQUINE SULFATE LAURUS LABS LTD Approval
01/16/2019 CLOZARIL
NDA #019758
SUPPL-90 CLOZAPINE HERITAGE LIFE REMS Approval
01/16/2019 TYLENOL
NDA #019872
SUPPL-48 ACETAMINOPHEN J AND J CONSUMER INC Labeling Approval
01/16/2019 LIORESAL
NDA #020075
SUPPL-37 BACLOFEN SAOL THERAPS RES LTD Labeling Approval
01/16/2019 WELCHOL
NDA #021176
SUPPL-44 COLESEVELAM HYDROCHLORIDE DAIICHI SANKYO Labeling Approval
01/16/2019 PREVANTICS MAXI SWABSTICK
NDA #021524
SUPPL-20 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL PROF DSPLS Labeling Approval
01/16/2019 PREVANTICS SWAB
NDA #021524
SUPPL-20 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL PROF DSPLS Labeling Approval
01/16/2019 PREVANTICS SWABSTICK
NDA #021524
SUPPL-20 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL PROF DSPLS Labeling Approval
01/16/2019 FAZACLO ODT
NDA #021590
SUPPL-31 CLOZAPINE JAZZ PHARMS III REMS Approval
01/16/2019 WELCHOL
NDA #022362
SUPPL-23 COLESEVELAM HYDROCHLORIDE DAIICHI SANKYO Labeling Approval
01/16/2019 CAPASTAT SULFATE
NDA #050095
SUPPL-72 CAPREOMYCIN SULFATE AKORN Labeling Approval
01/16/2019 CLOZAPINE
ANDA #074949
SUPPL-75 CLOZAPINE IVAX SUB TEVA PHARMS REMS Approval
01/16/2019 CLOZAPINE
ANDA #075417
SUPPL-41 CLOZAPINE MYLAN REMS Approval
01/16/2019 CLOZAPINE
ANDA #075713
SUPPL-45 CLOZAPINE SUN PHARM INDS INC REMS Approval
01/16/2019 CLOZAPINE
ANDA #076809
SUPPL-38 CLOZAPINE IVAX SUB TEVA PHARMS REMS Approval
01/16/2019 CLOZAPINE
ANDA #090308
SUPPL-3 CLOZAPINE BARR LABS INC REMS Approval
01/16/2019 CAMPATH
BLA #103948
SUPPL-5163 ALEMTUZUMAB GENZYME Approval
01/16/2019 CAMPATH
BLA #103948
SUPPL-5164 ALEMTUZUMAB GENZYME Approval
01/16/2019 LEMTRADA
BLA #103948
SUPPL-5163 ALEMTUZUMAB GENZYME Approval
01/16/2019 LEMTRADA
BLA #103948
SUPPL-5164 ALEMTUZUMAB GENZYME Approval
01/16/2019 CLOZAPINE
ANDA #201824
SUPPL-9 CLOZAPINE MYLAN PHARMS INC REMS Approval
01/16/2019 CLOZAPINE
ANDA #202873
SUPPL-5 CLOZAPINE ACCORD HLTHCARE REMS Approval
01/16/2019 CLOZAPINE
ANDA #203039
SUPPL-5 CLOZAPINE TEVA PHARMS USA REMS Approval
01/16/2019 VERSACLOZ
NDA #203479
SUPPL-11 CLOZAPINE TASMAN PHARMA REMS Approval
01/16/2019 CLOZAPINE
ANDA #203807
SUPPL-6 CLOZAPINE MAYNE PHARMA REMS Approval
01/16/2019 ACETAZOLAMIDE
ANDA #205301
ORIG-1 ACETAZOLAMIDE XYLOPIA Approval
01/16/2019 PRASUGREL
ANDA #206021
ORIG-1 PRASUGREL HYDROCHLORIDE HEC PHARM Approval
01/16/2019 CLOZAPINE
ANDA #206433
SUPPL-4 CLOZAPINE AUROBINDO PHARMA LTD REMS Approval
01/16/2019 ISOSULFAN BLUE
ANDA #210714
ORIG-1 ISOSULFAN BLUE BELOTECA INC Approval
01/16/2019 TRIENTINE HYDROCHLORIDE
ANDA #211251
ORIG-1 TRIENTINE HYDROCHLORIDE NAVINTA LLC Approval
01/17/2019 ALDACTAZIDE
NDA #012616
SUPPL-78 HYDROCHLOROTHIAZIDE; SPIRONOLACTONE GD SEARLE LLC Labeling Approval
01/17/2019 LEVEMIR
NDA #021536
SUPPL-54 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Labeling Approval
01/17/2019 LEVEMIR FLEXPEN
NDA #021536
SUPPL-54 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Labeling Approval
01/17/2019 LEVEMIR FLEXTOUCH
NDA #021536
SUPPL-54 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Labeling Approval
01/17/2019 LEVEMIR INNOLET
NDA #021536
SUPPL-54 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Labeling Approval
01/17/2019 LEVEMIR PENFILL
NDA #021536
SUPPL-54 INSULIN DETEMIR RECOMBINANT NOVO NORDISK INC Labeling Approval
01/17/2019 REVATIO
NDA #022473
SUPPL-12 SILDENAFIL CITRATE PFIZER Labeling Approval
01/17/2019 ATORVASTATIN CALCIUM
ANDA #090548
SUPPL-19 ATORVASTATIN CALCIUM APOTEX INC Labeling Approval
01/17/2019 REVATIO
NDA #203109
SUPPL-12 SILDENAFIL CITRATE PFIZER Labeling Approval
01/17/2019 IMATINIB MESYLATE
ANDA #208302
ORIG-1 IMATINIB MESYLATE SHILPA MEDICARE LTD Approval
01/17/2019 IMATINIB MESYLATE
ANDA #208429
ORIG-1 IMATINIB MESYLATE WOCKHARDT BIO AG Approval
01/18/2019 ENTOCORT EC
NDA #021324
SUPPL-18 BUDESONIDE PERRIGO PHARMA INTL Labeling Approval
01/18/2019 NEUPRO
NDA #021829
SUPPL-16 ROTIGOTINE UCB INC Labeling Approval
01/18/2019 INCRELEX
NDA #021839
SUPPL-21 MECASERMIN RECOMBINANT IPSEN INC Labeling Approval
01/18/2019 EGRIFTA
NDA #022505
SUPPL-11 TESAMORELIN ACETATE THERATECHNOLOGIES Labeling Approval
01/18/2019 TAPAZOLE
ANDA #040320
SUPPL-12 METHIMAZOLE KING PHARMS LLC Labeling Approval
01/18/2019 METHIMAZOLE
ANDA #040350
SUPPL-23 METHIMAZOLE MYLAN Labeling Approval
01/18/2019 METHIMAZOLE
ANDA #040411
SUPPL-28 METHIMAZOLE CASI PHARMS INC Labeling Approval
01/18/2019 METHIMAZOLE
ANDA #040547
SUPPL-11 METHIMAZOLE ECI PHARMS LLC Labeling Approval
01/18/2019 METHIMAZOLE
ANDA #040619
SUPPL-4 METHIMAZOLE ECI PHARMS LLC Labeling Approval
01/18/2019 METHIMAZOLE
ANDA #040734
SUPPL-7 METHIMAZOLE HERITAGE PHARMA Labeling Approval
01/18/2019 METHIMAZOLE
ANDA #040870
SUPPL-8 METHIMAZOLE SUN PHARM INDS INC Labeling Approval
01/18/2019 RETACRIT
BLA #125545
SUPPL-3 EPOETIN ALFA-EPBX HOSPIRA INC Approval
01/18/2019 ERIVEDGE
NDA #203388
SUPPL-12 VISMODEGIB GENENTECH Efficacy Approval
01/18/2019 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #204843
ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE CIPLA Approval
01/18/2019 ESOMEPRAZOLE MAGNESIUM
ANDA #206296
ORIG-1 ESOMEPRAZOLE MAGNESIUM ZYDUS PHARMS USA INC Tentative Approval
01/18/2019 LANSOPRAZOLE
ANDA #207394
ORIG-1 LANSOPRAZOLE ALKEM LABS LTD Approval
01/18/2019 CARFILZOMIB
ANDA #209425
ORIG-1 CARFILZOMIB APOTEX INC Tentative Approval
01/18/2019 CARFILZOMIB
ANDA #209528
ORIG-1 CARFILZOMIB QILU PHARM CO LTD Tentative Approval
01/18/2019 LEVOTHYROXINE SODIUM
ANDA #209713
ORIG-1 LEVOTHYROXINE SODIUM LUPIN ATLANTIS Approval
01/18/2019 MOXIDECTIN
NDA #210867
SUPPL-1 MOXIDECTIN MDGH Labeling Approval
01/18/2019 DAPAGLIFLOZIN
ANDA #211439
ORIG-1 DAPAGLIFLOZIN HETERO LABS UNIT III Tentative Approval
01/18/2019 CYCLOPHOSPHAMIDE
ANDA #211608
ORIG-1 CYCLOPHOSPHAMIDE CIPLA Approval
01/18/2019 ACYCLOVIR
ANDA #211794
ORIG-1 ACYCLOVIR CIPLA Approval
01/18/2019 LIBTAYO
BLA #761097
SUPPL-2 CEMIPLIMAB-RWLC REGENERON PHARMACEUTICALS Approval
01/18/2019 ONTRUZANT
BLA #761100
ORIG-1 TRASTUZUMAB-DTTB SAMSUNG BIOEPIS CO LTD Approval
01/22/2019 PRANDIN
NDA #020741
SUPPL-44 REPAGLINIDE GEMINI LABS LLC Labeling Approval
01/22/2019 REVLIMID
NDA #021880
SUPPL-56 LENALIDOMIDE CELGENE Labeling Approval
01/22/2019 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #205401
ORIG-1 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE AMERIGEN PHARMS LTD Approval
01/22/2019 POTASSIUM CHLORIDE
ANDA #206881
ORIG-1 POTASSIUM CHLORIDE PII Approval
01/22/2019 ABIRATERONE ACETATE
ANDA #209227
ORIG-1 ABIRATERONE ACETATE GLENMARK PHARMS SA Tentative Approval
01/22/2019 TOPIRAMATE
ANDA #210278
ORIG-1 TOPIRAMATE GLENMARK PHARMS LTD Tentative Approval
01/22/2019 DOFETILDE
ANDA #210740
ORIG-1 DOFETILIDE AUROBINDO PHARMA LTD Approval
01/22/2019 TRETINOIN
ANDA #211645
ORIG-1 TRETINOIN TARO PHARMS Approval
01/23/2019 FLOMAX
NDA #020579
SUPPL-33 TAMSULOSIN HYDROCHLORIDE SANOFI AVENTIS US Labeling Approval
01/23/2019 RIFADIN
NDA #050420
SUPPL-78 RIFAMPIN SANOFI AVENTIS US Labeling Approval
01/23/2019 RIMACTANE
NDA #050429
SUPPL-86 RIFAMPIN OXFORD PHARMS Labeling Approval
01/23/2019 RIFADIN
NDA #050627
SUPPL-21 RIFAMPIN SANOFI AVENTIS US Labeling Approval
01/23/2019 RIFATER
NDA #050705
SUPPL-13 ISONIAZID; PYRAZINAMIDE; RIFAMPIN SANOFI AVENTIS US Labeling Approval
01/23/2019 METHIMAZOLE
ANDA #202068
SUPPL-4 METHIMAZOLE RISING PHARMS Labeling Approval
01/23/2019 SYNRIBO
NDA #203585
SUPPL-6 OMACETAXINE MEPESUCCINATE TEVA PHARMS INTL Labeling Approval
01/23/2019 HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #206661
ORIG-1 HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE TORRENT Approval
01/23/2019 TICAGRELOR
ANDA #208531
ORIG-1 TICAGRELOR AMNEAL PHARMS CO Approval
01/23/2019 TICAGRELOR
ANDA #208575
ORIG-1 TICAGRELOR HISUN PHARM HANGZHOU Approval
01/23/2019 CLOBETASOL PROPIONATE
ANDA #208589
ORIG-1 CLOBETASOL PROPIONATE TELIGENT PHARMA INC Approval
01/23/2019 BRAFTOVI
NDA #210496
SUPPL-1 ENCORAFENIB ARRAY BIOPHARMA INC Efficacy Approval
01/23/2019 MEKTOVI
NDA #210498
SUPPL-1 BINIMETINIB ARRAY BIOPHARMA INC Efficacy Approval
01/24/2019 SUBLIMAZE PRESERVATIVE FREE
NDA #016619
SUPPL-39 FENTANYL CITRATE AKORN Labeling Approval
01/24/2019 FENTANYL CITRATE PRESERVATIVE FREE
NDA #019101
SUPPL-47 FENTANYL CITRATE WEST-WARD PHARMS INT Labeling Approval
01/24/2019 PENICILLIN G PROCAINE
ANDA #060101
SUPPL-39 PENICILLIN G PROCAINE KING PHARMS LLC Labeling Approval
01/24/2019 TOPIRAMATE
ANDA #079153
SUPPL-20 TOPIRAMATE TORRENT PHARMS Labeling Approval
01/24/2019 TOPIRAMATE
ANDA #079153
SUPPL-21 TOPIRAMATE TORRENT PHARMS Labeling Approval
01/24/2019 BUPROPION HYDROCHLORIDE
ANDA #090693
SUPPL-6 BUPROPION HYDROCHLORIDE LUPIN LTD Labeling Approval
01/24/2019 LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
ANDA #200492
SUPPL-5 ETHINYL ESTRADIOL; LEVONORGESTREL MYLAN LABS LTD Labeling Approval
01/24/2019 LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
ANDA #200493
SUPPL-4 ETHINYL ESTRADIOL; LEVONORGESTREL MYLAN LABS LTD Labeling Approval
01/24/2019 DORZOLAMIDE HYDROCHLORIDE
ANDA #205294
ORIG-1 DORZOLAMIDE HYDROCHLORIDE FDC LTD Approval
01/24/2019 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #205954
ORIG-1 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE ALVOGEN PINE BROOK Approval
01/24/2019 LYMEPAK
NDA #209844
SUPPL-1 DOXYCYCLINE HYCLATE CHARTWELL PHARMA Labeling Approval
01/24/2019 OXYCODONE HYDROCHLORIDE
ANDA #210758
SUPPL-1 OXYCODONE HYDROCHLORIDE SPECGX LLC Labeling Approval
01/24/2019 OXYCODONE HYDROCHLORIDE
ANDA #210758
SUPPL-3 OXYCODONE HYDROCHLORIDE SPECGX LLC REMS Approval
01/25/2019 ZOVIRAX
NDA #018603
SUPPL-30 ACYCLOVIR SODIUM GLAXOSMITHKLINE Labeling Approval
01/25/2019 EXIDINE
NDA #019422
SUPPL-49 CHLORHEXIDINE GLUCONATE XTTRIUM Manufacturing (CMC) Approval
01/25/2019 RISPERDAL
NDA #020272
SUPPL-82 RISPERIDONE JANSSEN PHARMS Labeling Approval
01/25/2019 RISPERDAL
NDA #020588
SUPPL-70 RISPERIDONE JANSSEN PHARMS Labeling Approval
01/25/2019 RISPERDAL CONSTA
NDA #021346
SUPPL-60 RISPERIDONE JANSSEN PHARMS Labeling Approval
01/25/2019 RISPERDAL
NDA #021444
SUPPL-56 RISPERIDONE JANSSEN PHARMS Labeling Approval
01/25/2019 INVEGA
NDA #021999
SUPPL-36 PALIPERIDONE JANSSEN PHARMS Labeling Approval
01/25/2019 ADVIL ALLERGY AND CONGESTION RELIEF
NDA #022113
SUPPL-5 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE PFIZER Labeling Approval
01/25/2019 ADVIL MULTI-SYMPTOM COLD & FLU
NDA #022113
SUPPL-5 CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE PFIZER Labeling Approval
01/25/2019 INVEGA SUSTENNA
NDA #022264
SUPPL-29 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
01/25/2019 CALDOLOR
NDA #022348
SUPPL-13 IBUPROFEN CUMBERLAND PHARMS Manufacturing (CMC) Approval
01/25/2019 RITUXAN
BLA #103705
SUPPL-5454 RITUXIMAB GENENTECH Approval
01/25/2019 PHOTREXA
NDA #203324
SUPPL-6 RIBOFLAVIN 5'-PHOSPHATE SODIUM AVEDRO INC Labeling Approval
01/25/2019 PHOTREXA VISCOUS IN DEXTRAN 20%
NDA #203324
SUPPL-6 RIBOFLAVIN 5'-PHOSPHATE SODIUM AVEDRO INC Labeling Approval
01/25/2019 OSPHENA
NDA #203505
SUPPL-15 OSPEMIFENE DUCHESNAY Efficacy Approval
01/25/2019 IMBRUVICA
NDA #205552
SUPPL-26 IBRUTINIB PHARMACYCLICS INC Efficacy Approval
01/25/2019 ESOMEPRAZOLE MAGNESIUM
ANDA #207265
SUPPL-1 ESOMEPRAZOLE MAGNESIUM HEC PHARM Manufacturing (CMC) Approval
01/25/2019 NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #207597
ORIG-1 DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM ACTAVIS ELIZABETH Approval
01/25/2019 INVEGA TRINZA
NDA #207946
SUPPL-8 PALIPERIDONE PALMITATE JANSSEN PHARMS Labeling Approval
01/25/2019 BENDAMUSTINE HYDROCHLORIDE
ANDA #209814
ORIG-1 BENDAMUSTINE HYDROCHLORIDE CELERITY PHARMS Tentative Approval
01/25/2019 EPTIFIBATIDE
ANDA #209864
ORIG-1 EPTIFIBATIDE HAINAN POLY PHARM Approval
01/25/2019 DICYCLOMINE HYDROCHLORIDE
ANDA #210257
ORIG-1 DICYCLOMINE HYDROCHLORIDE FRESENIUS KABI USA Approval
01/25/2019 MEDROXYPROGESTERONE ACETATE
ANDA #210335
ORIG-1 MEDROXYPROGESTERONE ACETATE CIPLA Approval
01/25/2019 SYMTUZA
NDA #210455
SUPPL-1 COBICISTAT; DARUNAVIR ETHANOLATE; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE JANSSEN PRODS Labeling Approval
01/25/2019 IMBRUVICA
NDA #210563
SUPPL-2 IBRUTINIB PHARMACYCLICS INC Efficacy Approval
01/25/2019 TOSYMRA
NDA #210884
ORIG-1 SUMATRIPTAN DR REDDYS LABS LTD Type 3 - New Dosage Form Approval
01/25/2019 TRETINOIN
ANDA #211644
ORIG-1 TRETINOIN TARO PHARMS Approval
01/25/2019 DEXTROAMPHETAMINE SACCHARATE
ANDA #211715
ORIG-1 DEXTROAMPHETAMINE SACCHARATE SUN PHARM INDS INC Tentative Approval
01/25/2019 FLUOXETINE HYDROCHLORIDE
ANDA #211721
ORIG-1 FLUOXETINE HYDROCHLORIDE DR REDDYS LABS LTD Approval
01/25/2019 TIZANIDINE HYDROCHLORIDE
ANDA #211798
ORIG-1 TIZANIDINE HYDROCHLORIDE ALKEM LABS LTD Approval
01/25/2019 MESALAMINE
ANDA #211858
ORIG-1 MESALAMINE SUN PHARM INDS LTD Approval
01/25/2019 LUMOXITI
BLA #761104
SUPPL-1 MOXETUMOMAB PASUDOTOX-TDFK ASTRAZENECA AB Approval
01/28/2019 ALEVE
NDA #020204
SUPPL-61 NAPROXEN SODIUM BAYER Labeling Approval
01/28/2019 DIGOXIN
ANDA #040282
SUPPL-21 DIGOXIN MYLAN PHARMS INC Labeling Approval
01/28/2019 KETOROLAC TROMETHAMINE
ANDA #075772
SUPPL-5 KETOROLAC TROMETHAMINE WEST-WARD PHARMS INT Manufacturing (CMC) Approval
01/28/2019 AZELASTINE HYDROCHLORIDE
ANDA #077954
SUPPL-11 AZELASTINE HYDROCHLORIDE APOTEX INC Labeling Approval
01/28/2019 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200541
SUPPL-5 ETHINYL ESTRADIOL; NORGESTIMATE LUPIN PHARMS Labeling Approval
01/28/2019 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #200541
SUPPL-8 ETHINYL ESTRADIOL; NORGESTIMATE LUPIN PHARMS Manufacturing (CMC) Approval
01/28/2019 PREZCOBIX
NDA #205395
SUPPL-12 COBICISTAT; DARUNAVIR ETHANOLATE JANSSEN PRODS Labeling Approval
01/28/2019 LACTATED RINGER'S IN PLASTIC CONTAINER
ANDA #209338
ORIG-1 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE FRESENIUS KABI USA Approval
01/28/2019 OMEPRAZOLE
NDA #209400
SUPPL-5 OMEPRAZOLE DEXCEL PHARMA Labeling Approval
01/28/2019 CLINDAMYCIN PHOSPHATE
ANDA #209914
ORIG-1 CLINDAMYCIN PHOSPHATE ENCUBE ETHICALS Approval
01/28/2019 FOSAPREPITANT DIMEGLUMINE
ANDA #209965
ORIG-1 FOSAPREPITANT DIMEGLUMINE MSN LABS PVT LTD Tentative Approval
01/28/2019 DESMOPRESSIN ACETATE
ANDA #210371
ORIG-1 DESMOPRESSIN ACETATE ABHAI LLC Approval
01/28/2019 BUPROPION HYDROCHLORIDE
ANDA #211020
ORIG-1 BUPROPION HYDROCHLORIDE GRAVITI PHARMS Approval
01/28/2019 SIROLIMUS
ANDA #211040
ORIG-1 SIROLIMUS NOVITIUM PHARMA Approval
01/28/2019 TAZAROTENE
ANDA #211175
ORIG-1 TAZAROTENE FOUGERA PHARMS INC Approval
01/28/2019 ESLICARBAZEPINE ACETATE
ANDA #211199
ORIG-1 ESLICARBAZEPINE ACETATE ALKEM LABS LTD Tentative Approval
01/28/2019 NYSTATIN
ANDA #211838
ORIG-1 NYSTATIN TORRENT PHARMS LTD Approval
01/29/2019 VFEND
NDA #021266
SUPPL-39 VORICONAZOLE PF PRISM CV Efficacy Approval
01/29/2019 VFEND
NDA #021267
SUPPL-50 VORICONAZOLE PF PRISM CV Efficacy Approval
01/29/2019 VFEND
NDA #021630
SUPPL-29 VORICONAZOLE PF PRISM CV Efficacy Approval
01/29/2019 SIGNIFOR
NDA #200677
SUPPL-4 PASIREOTIDE DIASPARTATE NOVARTIS Labeling Approval
01/29/2019 SIGNIFOR LAR KIT
NDA #203255
SUPPL-5 PASIREOTIDE PAMOATE NOVARTIS PHARMS CORP Labeling Approval
01/29/2019 ADRENALIN
NDA #204200
SUPPL-9 EPINEPHRINE PAR STERILE PRODUCTS Efficacy Approval
01/29/2019 ADRENALIN
NDA #204640
SUPPL-9 EPINEPHRINE PAR STERILE PRODUCTS Efficacy Approval
01/29/2019 KHEDEZLA
NDA #204683
SUPPL-6 DESVENLAFAXINE OSMOTICA PHARM CORP Labeling Approval
01/29/2019 TREZIX
ANDA #204785
SUPPL-7 ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE WRASER PHARMS LLC REMS Approval
01/29/2019 PREGABALIN
ANDA #207799
ORIG-1 PREGABALIN ALKEM LABS LTD Tentative Approval
01/29/2019 ALOGLIPTIN
ANDA #210213
ORIG-1 ALOGLIPTIN BENZOATE MSN LABS PVT LTD Tentative Approval
01/29/2019 ARIPIPRAZOLE
ANDA #210479
ORIG-1 ARIPIPRAZOLE AUROBINDO PHARMA LTD Approval
01/29/2019 PHENYLEPHRINE HYDROCHLORIDE
ANDA #210665
ORIG-1 PHENYLEPHRINE HYDROCHLORIDE FRESENIUS KABI USA Approval
01/29/2019 BENDAMUSTINE
NDA #211530
ORIG-1 BENDAMUSTINE HOSPIRA Type 5 - New Formulation or New Manufacturer Tentative Approval
01/29/2019 TREMFYA
BLA #761061
SUPPL-1 GUSELKUMAB JANSSEN BIOTECH Approval
01/30/2019 ALIMTA
NDA #021462
SUPPL-53 PEMETREXED DISODIUM LILLY Efficacy Approval
01/30/2019 ARANESP
BLA #103951
SUPPL-5378 DARBEPOETIN ALFA AMGEN Approval
01/30/2019 CEFTAROLINE FOSAMIL
ANDA #208075
ORIG-1 CEFTAROLINE FOSAMIL APOTEX INC Tentative Approval
01/30/2019 WIXELA INHUB
ANDA #208891
ORIG-1 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE MYLAN PHARMS INC Approval
01/30/2019 EVEKEO ODT
NDA #209905
ORIG-1 AMPHETAMINE SULFATE ARBOR PHARMS LLC Type 3 - New Dosage Form Approval
01/30/2019 PHENYLEPHRINE HYDROCHLORIDE
ANDA #210666
ORIG-1 PHENYLEPHRINE HYDROCHLORIDE FRESENIUS KABI USA Approval
01/30/2019 GLOPERBA
NDA #210942
ORIG-1 COLCHICINE ROMEG THERAPS LLC Type 3 - New Dosage Form Approval
01/30/2019 DESONIDE
ANDA #210998
ORIG-1 DESONIDE ENCUBE ETHICALS Approval
01/30/2019 FLUOXETINE HYDROCHLORIDE
ANDA #211696
ORIG-1 FLUOXETINE HYDROCHLORIDE APPCO PHARMA LLC Approval
01/30/2019 CLOBAZAM
ANDA #211711
ORIG-1 CLOBAZAM MICRO LABS Approval
01/30/2019 BUDESONIDE
NDA #211929
ORIG-1 BUDESONIDE SUN PHARMA GLOBAL Type 5 - New Formulation or New Manufacturer Tentative Approval
01/31/2019 LAMPRENE
NDA #019500
SUPPL-14 CLOFAZIMINE NOVARTIS Labeling Approval
01/31/2019 NUEDEXTA
NDA #021879
SUPPL-12 DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE AVANIR PHARMS Labeling Approval
01/31/2019 PREZISTA
NDA #021976
SUPPL-54 DARUNAVIR ETHANOLATE JANSSEN PRODS Labeling Approval
01/31/2019 SALONPAS
NDA #022029
SUPPL-17 MENTHOL; METHYL SALICYLATE HISAMITSU PHARM CO Labeling Approval
01/31/2019 ESTRADIOL
ANDA #040114
SUPPL-25 ESTRADIOL MAYNE PHARMA Labeling Approval
01/31/2019 SERTRALINE HYDROCHLORIDE
ANDA #078861
SUPPL-15 SERTRALINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
01/31/2019 SERTRALINE HYDROCHLORIDE
ANDA #078861
SUPPL-16 SERTRALINE HYDROCHLORIDE AUROBINDO PHARMA Labeling Approval
01/31/2019 PREZISTA
NDA #202895
SUPPL-25 DARUNAVIR ETHANOLATE JANSSEN PRODS Labeling Approval
01/31/2019 PHENYLEPHRINE HYDROCHLORIDE
ANDA #208905
ORIG-1 PHENYLEPHRINE HYDROCHLORIDE SANDOZ INC Approval
01/31/2019 RANITIDINE HYDROCHLORIDE
ANDA #211289
ORIG-1 RANITIDINE HYDROCHLORIDE VKT PHARMA PVT LTD Approval
01/31/2019 TACROLIMUS
ANDA #211688
ORIG-1 TACROLIMUS ACCORD HLTHCARE Approval
* NDA Submission Classifications
For details, see FDA/CDER MAPP 5018.2
Classification Meaning
Type 1 New molecular entity
Type 2 New active ingredient
Type 3 New dosage form
Type 4 New combination
Type 5 New formulation or other differences
Type 6 New indication or claim, same applicant [no longer used]
Type 7 Previously marketed but without an approved NDA
Type 8 Rx to OTC
Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval
Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval
Type 1/4 Type 1, New molecular entity, and Type 4, New combination
Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form
Type 2/4 Type 2, New active ingredient and Type 4, New combination
Type 3/4 Type 3, New Dosage Form, and Type 4, New combination

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