Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
January 2020

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 January 19, 2020.

 

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Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
01/01/2020 PHOTOFRIN
NDA #020451
SUPPL-29 PORFIMER SODIUM PINNACLE BIOLGS Labeling Approval
01/01/2020 PHOTOFRIN
NDA #021525
SUPPL-5 PORFIMER SODIUM AXCAN SCANDIPHARM Labeling Approval
01/01/2020 LONSURF
NDA #207981
SUPPL-9 TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE TAIHO ONCOLOGY Labeling Approval
01/02/2020 RAPAMUNE
NDA #021083
SUPPL-67 SIROLIMUS PF PRISM CV Labeling Approval
01/02/2020 RAPAMUNE
NDA #021110
SUPPL-85 SIROLIMUS PF PRISM CV Labeling Approval
01/02/2020 WARFARIN SODIUM
ANDA #040145
SUPPL-60 WARFARIN SODIUM BARR Labeling Approval
01/02/2020 WARFARIN SODIUM
ANDA #040145
SUPPL-61 WARFARIN SODIUM BARR Labeling Approval
01/02/2020 WARFARIN SODIUM
ANDA #040145
SUPPL-64 WARFARIN SODIUM BARR Labeling Approval
01/02/2020 WARFARIN SODIUM
ANDA #040145
SUPPL-65 WARFARIN SODIUM BARR Labeling Approval
01/02/2020 NEVIRAPINE
ANDA #078195
SUPPL-13 NEVIRAPINE STRIDES PHARMA Labeling Approval
01/02/2020 DONEPEZIL HYDROCHLORIDE
ANDA #090175
SUPPL-8 DONEPEZIL HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
01/02/2020 RASAGILINE MESYLATE
ANDA #201889
SUPPL-3 RASAGILINE MESYLATE ALKEM LABS LTD Labeling Approval
01/02/2020 RASAGILINE MESYLATE
ANDA #201970
SUPPL-1 RASAGILINE MESYLATE ORCHID HLTHCARE Labeling Approval
01/02/2020 RASAGILINE MESYLATE
ANDA #201970
SUPPL-4 RASAGILINE MESYLATE ORCHID HLTHCARE Labeling Approval
01/02/2020 RASAGILINE MESYLATE
ANDA #201971
SUPPL-3 RASAGILINE MESYLATE MYLAN Labeling Approval
01/02/2020 MESALAMINE
ANDA #210509
ORIG-1 MESALAMINE AMNEAL PHARMS LLC Approval
01/02/2020 DEFERASIROX
ANDA #211641
ORIG-1 DEFERASIROX SUN PHARM Approval
01/03/2020 FARESTON
NDA #020497
SUPPL-10 TOREMIFENE CITRATE KYOWA KIRIN Labeling Approval
01/03/2020 DIVALPROEX SODIUM
ANDA #077567
SUPPL-14 DIVALPROEX SODIUM MYLAN Labeling Approval
01/03/2020 DIVALPROEX SODIUM
ANDA #077567
SUPPL-17 DIVALPROEX SODIUM MYLAN Labeling Approval
01/03/2020 DIVALPROEX SODIUM
ANDA #077567
SUPPL-19 DIVALPROEX SODIUM MYLAN Labeling Approval
01/03/2020 DIVALPROEX SODIUM
ANDA #077567
SUPPL-20 DIVALPROEX SODIUM MYLAN Labeling Approval
01/03/2020 DIVALPROEX SODIUM
ANDA #077567
SUPPL-24 DIVALPROEX SODIUM MYLAN Labeling Approval
01/03/2020 DIVALPROEX SODIUM
ANDA #077567
SUPPL-26 DIVALPROEX SODIUM MYLAN Labeling Approval
01/03/2020 DIVALPROEX SODIUM
ANDA #078182
SUPPL-13 DIVALPROEX SODIUM UPSHER SMITH LABS Labeling Approval
01/03/2020 DIVALPROEX SODIUM
ANDA #078182
SUPPL-14 DIVALPROEX SODIUM UPSHER SMITH LABS Labeling Approval
01/03/2020 DIVALPROEX SODIUM
ANDA #078182
SUPPL-15 DIVALPROEX SODIUM UPSHER SMITH LABS Labeling Approval
01/03/2020 DIVALPROEX SODIUM
ANDA #078182
SUPPL-16 DIVALPROEX SODIUM UPSHER SMITH LABS Labeling Approval
01/03/2020 DIVALPROEX SODIUM
ANDA #078182
SUPPL-17 DIVALPROEX SODIUM UPSHER SMITH LABS Labeling Approval
01/03/2020 PANTOPRAZOLE SODIUM
ANDA #078281
SUPPL-19 PANTOPRAZOLE SODIUM LANNETT CO INC Labeling Approval
01/03/2020 PANTOPRAZOLE SODIUM
ANDA #078281
SUPPL-21 PANTOPRAZOLE SODIUM LANNETT CO INC Labeling Approval
01/03/2020 PANTOPRAZOLE SODIUM
ANDA #078281
SUPPL-22 PANTOPRAZOLE SODIUM LANNETT CO INC Labeling Approval
01/03/2020 PANTOPRAZOLE SODIUM
ANDA #078281
SUPPL-23 PANTOPRAZOLE SODIUM LANNETT CO INC Labeling Approval
01/03/2020 PANTOPRAZOLE SODIUM
ANDA #078281
SUPPL-24 PANTOPRAZOLE SODIUM LANNETT CO INC Labeling Approval
01/03/2020 FLUDEOXYGLUCOSE F18
ANDA #079086
SUPPL-21 FLUDEOXYGLUCOSE F-18 PETNET Labeling Approval
01/03/2020 DOXEPIN HYDROCHLORIDE
ANDA #201951
SUPPL-4 DOXEPIN HYDROCHLORIDE ACTAVIS ELIZABETH Manufacturing (CMC) Approval
01/03/2020 MARQIBO KIT
NDA #202497
SUPPL-10 VINCRISTINE SULFATE ACROTECH Labeling Approval
01/03/2020 FLUDEOXYGLUCOSE F18
ANDA #203816
SUPPL-1 FLUDEOXYGLUCOSE F-18 BRIGHAM WOMENS Labeling Approval
01/03/2020 FLUDEOXYGLUCOSE F18
ANDA #203935
SUPPL-5 FLUDEOXYGLUCOSE F-18 WUSM CYCLOTRON Labeling Approval
01/03/2020 FLUDEOXYGLUCOSE F18
ANDA #203946
SUPPL-3 FLUDEOXYGLUCOSE F-18 ESSENTIAL ISOTOPES Labeling Approval
01/03/2020 FLUDEOXYGLUCOSE F18
ANDA #204525
SUPPL-1 FLUDEOXYGLUCOSE F-18 CPDC Labeling Approval
01/03/2020 DEFERASIROX
ANDA #209433
ORIG-1 DEFERASIROX ICHNOS Approval
01/03/2020 BOSENTAN
ANDA #210342
ORIG-1 BOSENTAN CIPLA Approval
01/03/2020 HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #211729
ORIG-1 ACETAMINOPHEN; HYDROCODONE BITARTRATE GRANULES PHARMS Approval
01/06/2020 AZELEX
NDA #020428
SUPPL-22 AZELAIC ACID ALMIRALL Labeling Approval
01/06/2020 NEULASTA
BLA #125031
SUPPL-199 PEGFILGRASTIM AMGEN Approval
01/06/2020 DOCETAXEL
NDA #201525
SUPPL-19 DOCETAXEL SANDOZ Labeling Approval
01/06/2020 SIRTURO
NDA #204384
SUPPL-14 BEDAQUILINE FUMARATE JANSSEN THERAP Labeling Approval
01/06/2020 IBUPROFEN
ANDA #209076
ORIG-1 IBUPROFEN ULTRATAB LABS INC Approval
01/06/2020 KLOR-CON
ANDA #209662
SUPPL-2 POTASSIUM CHLORIDE UPSHER SMITH LABS Labeling Approval
01/06/2020 DARIFENACIN HYDROBROMIDE
ANDA #211045
ORIG-1 DARIFENACIN HYDROBROMIDE POLYGEN PHARMS Approval
01/06/2020 PROPRANOLOL HYDROCHLORIDE
ANDA #212026
ORIG-1 PROPRANOLOL HYDROCHLORIDE AMTA Approval
01/07/2020 GIAZO
NDA #022205
SUPPL-3 BALSALAZIDE DISODIUM VALEANT PHARMS INTL Labeling Approval
01/07/2020 PAMIDRONATE DISODIUM
ANDA #075841
SUPPL-19 PAMIDRONATE DISODIUM HOSPIRA Labeling Approval
01/07/2020 ABACAVIR SULFATE AND LAMIVUDINE
ANDA #090159
SUPPL-2 ABACAVIR SULFATE; LAMIVUDINE AUROBINDO PHARMA LTD Labeling Approval
01/07/2020 FAMOTIDINE
ANDA #090440
SUPPL-3 FAMOTIDINE LUPIN LTD Manufacturing (CMC) Approval
01/07/2020 TENOFOVIR DISOPROXIL FUMARATE
ANDA #203232
SUPPL-6 TENOFOVIR DISOPROXIL FUMARATE MACLEODS PHARMS LTD Labeling Approval
01/07/2020 TENOFOVIR DISOPROXIL FUMARATE
ANDA #203232
SUPPL-7 TENOFOVIR DISOPROXIL FUMARATE MACLEODS PHARMS LTD Labeling Approval
01/07/2020 TENOFOVIR DISOPROXIL FUMARATE
ANDA #203232
SUPPL-11 TENOFOVIR DISOPROXIL FUMARATE MACLEODS PHARMS LTD Labeling Approval
01/07/2020 DIHYDROERGOTAMINE MESYLATE
ANDA #212046
ORIG-1 DIHYDROERGOTAMINE MESYLATE APOLLO Approval
01/08/2020 FUSILEV
NDA #020140
SUPPL-24 LEVOLEUCOVORIN CALCIUM ACROTECH Labeling Approval
01/08/2020 GENOTROPIN
NDA #020280
SUPPL-90 SOMATROPIN PHARMACIA Labeling Approval
01/08/2020 GENOTROPIN PRESERVATIVE FREE
NDA #020280
SUPPL-90 SOMATROPIN PHARMACIA Labeling Approval
01/08/2020 AZITHROMYCIN
ANDA #065209
SUPPL-30 AZITHROMYCIN SANDOZ Labeling Approval
01/08/2020 AZITHROMYCIN
ANDA #065211
SUPPL-34 AZITHROMYCIN SANDOZ Labeling Approval
01/08/2020 AZITHROMYCIN
ANDA #065212
SUPPL-32 AZITHROMYCIN SANDOZ Labeling Approval
01/08/2020 AZITHROMYCIN
ANDA #065218
SUPPL-19 AZITHROMYCIN PLIVA Labeling Approval
01/08/2020 AZITHROMYCIN
ANDA #065218
SUPPL-20 AZITHROMYCIN PLIVA Labeling Approval
01/08/2020 AZITHROMYCIN
ANDA #065218
SUPPL-21 AZITHROMYCIN PLIVA Labeling Approval
01/08/2020 AZITHROMYCIN
ANDA #065218
SUPPL-22 AZITHROMYCIN PLIVA Labeling Approval
01/08/2020 AZITHROMYCIN
ANDA #065506
SUPPL-15 AZITHROMYCIN MYLAN ASI Labeling Approval
01/08/2020 AZITHROMYCIN
ANDA #065506
SUPPL-17 AZITHROMYCIN MYLAN ASI Labeling Approval
01/08/2020 AZITHROMYCIN
ANDA #065506
SUPPL-18 AZITHROMYCIN MYLAN ASI Labeling Approval
01/08/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #090710
SUPPL-10 METHYLPHENIDATE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
01/08/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #090710
SUPPL-12 METHYLPHENIDATE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
01/08/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #090710
SUPPL-15 METHYLPHENIDATE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
01/08/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #090710
SUPPL-19 METHYLPHENIDATE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
01/08/2020 METHYLPHENIDATE HYDROCHLORIDE
ANDA #090710
SUPPL-23 METHYLPHENIDATE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
01/08/2020 KEYTRUDA
BLA #125514
SUPPL-66 PEMBROLIZUMAB MERCK SHARP DOHME Approval
01/08/2020 DIVALPROEX SODIUM
ANDA #203730
SUPPL-4 DIVALPROEX SODIUM AMNEAL PHARMS Labeling Approval
01/08/2020 DIVALPROEX SODIUM
ANDA #203730
SUPPL-7 DIVALPROEX SODIUM AMNEAL PHARMS Labeling Approval
01/08/2020 DIVALPROEX SODIUM
ANDA #203730
SUPPL-8 DIVALPROEX SODIUM AMNEAL PHARMS Labeling Approval
01/08/2020 DIVALPROEX SODIUM
ANDA #203730
SUPPL-10 DIVALPROEX SODIUM AMNEAL PHARMS Labeling Approval
01/08/2020 ZOLMITRIPTAN
ANDA #204284
SUPPL-6 ZOLMITRIPTAN INVAGEN PHARMS Labeling Approval
01/08/2020 BELEODAQ
NDA #206256
SUPPL-3 BELINOSTAT ACROTECH Labeling Approval
01/08/2020 INFUGEM
NDA #208313
SUPPL-2 GEMCITABINE HYDROCHLORIDE SUN PHARM Labeling Approval
01/08/2020 HALOPERIDOL
ANDA #211061
ORIG-1 HALOPERIDOL APPCO Approval
01/08/2020 NICOTINE POLACRILEX
ANDA #212796
ORIG-1 NICOTINE POLACRILEX DR REDDYS LABS SA Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #077100
SUPPL-22 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #077100
SUPPL-25 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #077100
SUPPL-26 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #077100
SUPPL-28 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #077100
SUPPL-29 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #077100
SUPPL-30 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #077296
SUPPL-7 DIVALPROEX SODIUM CELLTRION Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #077296
SUPPL-8 DIVALPROEX SODIUM CELLTRION Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #078239
SUPPL-18 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #078239
SUPPL-19 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #078239
SUPPL-21 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #078239
SUPPL-22 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #078239
SUPPL-23 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #078239
SUPPL-24 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #078919
SUPPL-17 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #078919
SUPPL-18 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #078919
SUPPL-19 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #078919
SUPPL-20 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #078919
SUPPL-22 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #078919
SUPPL-23 DIVALPROEX SODIUM ZYDUS PHARMS USA INC Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #079163
SUPPL-8 DIVALPROEX SODIUM UNICHEM LABS LTD Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #079163
SUPPL-11 DIVALPROEX SODIUM UNICHEM LABS LTD Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #079163
SUPPL-16 DIVALPROEX SODIUM UNICHEM LABS LTD Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #079163
SUPPL-17 DIVALPROEX SODIUM UNICHEM LABS LTD Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #079163
SUPPL-18 DIVALPROEX SODIUM UNICHEM LABS LTD Labeling Approval
01/09/2020 DIVALPROEX SODIUM
ANDA #079163
SUPPL-20 DIVALPROEX SODIUM UNICHEM LABS LTD Labeling Approval
01/09/2020 KEYTRUDA
BLA #125514
SUPPL-67 PEMBROLIZUMAB MERCK SHARP DOHME Approval
01/09/2020 IMATINIB MESYLATE
ANDA #204285
SUPPL-2 IMATINIB MESYLATE TEVA PHARMS USA Labeling Approval
01/09/2020 IMATINIB MESYLATE
ANDA #204285
SUPPL-3 IMATINIB MESYLATE TEVA PHARMS USA Labeling Approval
01/09/2020 IMATINIB MESYLATE
ANDA #204285
SUPPL-4 IMATINIB MESYLATE TEVA PHARMS USA Labeling Approval
01/09/2020 IMATINIB MESYLATE
ANDA #204285
SUPPL-5 IMATINIB MESYLATE TEVA PHARMS USA Labeling Approval
01/09/2020 IMATINIB MESYLATE
ANDA #204285
SUPPL-7 IMATINIB MESYLATE TEVA PHARMS USA Labeling Approval
01/09/2020 PYRIDOSTIGMINE BROMIDE
ANDA #208797
ORIG-1 PYRIDOSTIGMINE BROMIDE INVATECH Approval
01/09/2020 OMEGA-3-ACID ETHYL ESTERS
ANDA #210834
ORIG-1 OMEGA-3-ACID ETHYL ESTERS SUN PHARM Approval
01/09/2020 AYVAKIT
NDA #212608
ORIG-1 AVAPRITINIB BLUEPRINT MEDICINES CORP Type 1 - New Molecular Entity Approval
01/09/2020 EVEROLIMUS
ANDA #212936
ORIG-1 EVEROLIMUS MYLAN PHARMS INC Tentative Approval
01/10/2020 ATROVENT HFA
NDA #021527
SUPPL-33 IPRATROPIUM BROMIDE BOEHRINGER INGELHEIM Labeling Approval
01/10/2020 VIZAMYL
NDA #203137
SUPPL-13 FLUTEMETAMOL F-18 GE HEALTHCARE Labeling Approval
01/10/2020 ICLUSIG
NDA #203469
SUPPL-31 PONATINIB HYDROCHLORIDE ARIAD Labeling Approval
01/10/2020 NEURACEQ
NDA #204677
SUPPL-19 FLORBETABEN F-18 LIFE MOLECULAR Labeling Approval
01/10/2020 VILAZODONE HYDROCHLORIDE
ANDA #208202
ORIG-1 VILAZODONE HYDROCHLORIDE ALEMBIC PHARMS LTD Approval
01/10/2020 THIOTEPA
ANDA #208242
ORIG-1 THIOTEPA STI PHARMA LLC Approval
01/10/2020 NUMBRINO
NDA #209575
ORIG-1 COCAINE HYDROCHLORIDE Cody Laboratories, Inc. Type 7 - Drug Already Marketed without Approved NDA Approval
01/10/2020 VALTOCO
NDA #211635
ORIG-1 DIAZEPAM NEURELIS INC Type 3 - New Dosage Form Approval
01/10/2020 PREGABALIN
ANDA #212280
ORIG-1 PREGABALIN CIPLA Approval
01/10/2020 PYRIDOSTIGMINE BROMIDE
ANDA #212702
ORIG-1 PYRIDOSTIGMINE BROMIDE AMNEAL PHARMS LLC Approval
01/10/2020 OCREVUS
BLA #761053
SUPPL-20 OCRELIZUMAB GENENTECH INC Approval
01/13/2020 AZITHROMYCIN
ANDA #065246
SUPPL-25 AZITHROMYCIN PLIVA Labeling Approval
01/13/2020 AZITHROMYCIN
ANDA #065246
SUPPL-26 AZITHROMYCIN PLIVA Labeling Approval
01/13/2020 TOPOTECAN HYDROCHLORIDE
ANDA #090620
SUPPL-8 TOPOTECAN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
01/13/2020 TOPOTECAN HYDROCHLORIDE
ANDA #090620
SUPPL-9 TOPOTECAN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
01/13/2020 ZOLMITRIPTAN
ANDA #201779
SUPPL-2 ZOLMITRIPTAN GLENMARK GENERICS Labeling Approval
01/13/2020 VALCHLOR
NDA #202317
SUPPL-9 MECHLORETHAMINE HYDROCHLORIDE HELSINN Labeling Approval
01/13/2020 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202673
SUPPL-3 LEVOCETIRIZINE DIHYDROCHLORIDE TARO PHARM INDS LTD Labeling Approval
01/13/2020 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202673
SUPPL-4 LEVOCETIRIZINE DIHYDROCHLORIDE TARO PHARM INDS LTD Labeling Approval
01/13/2020 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202673
SUPPL-5 LEVOCETIRIZINE DIHYDROCHLORIDE TARO PHARM INDS LTD Labeling Approval
01/13/2020 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202673
SUPPL-6 LEVOCETIRIZINE DIHYDROCHLORIDE TARO PHARM INDS LTD Labeling Approval
01/13/2020 LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202673
SUPPL-7 LEVOCETIRIZINE DIHYDROCHLORIDE TARO PHARM INDS LTD Labeling Approval
01/13/2020 LICART
NDA #206976
SUPPL-3 DICLOFENAC EPOLAMINE IBSA INST BIO Labeling Approval
01/13/2020 VYXEOS
NDA #209401
SUPPL-2 CYTARABINE; DAUNORUBICIN CELATOR PHARMS Labeling Approval
01/13/2020 AZITHROMYCIN
ANDA #211147
SUPPL-3 AZITHROMYCIN ZYDUS Labeling Approval
01/13/2020 BORTEZOMIB
ANDA #212825
ORIG-1 BORTEZOMIB EUGIA PHARMA Tentative Approval
01/13/2020 VALGANCICLOVIR HYDROCHLORIDE
ANDA #212890
ORIG-1 VALGANCICLOVIR HYDROCHLORIDE AJANTA PHARMA LTD Approval
01/13/2020 TIZANIDINE HYDROCHLORIDE
ANDA #213223
ORIG-1 TIZANIDINE HYDROCHLORIDE ALEMBIC PHARMS LTD Approval
01/14/2020 EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #090513
SUPPL-10 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE AUROBINDO PHARMA LTD Labeling Approval
01/14/2020 JAKAFI
NDA #202192
SUPPL-19 RUXOLITINIB PHOSPHATE INCYTE CORP Labeling Approval
01/14/2020 TRANEXAMIC ACID
ANDA #209860
ORIG-1 TRANEXAMIC ACID APOTEX Approval
01/14/2020 EMPAGLIFLOZIN
ANDA #212355
ORIG-1 EMPAGLIFLOZIN ALEMBIC LTD Tentative Approval
01/14/2020 POTASSIUM CITRATE
ANDA #212779
ORIG-1 POTASSIUM CITRATE ANI PHARMS INC Approval
01/14/2020 IXIFI
BLA #761072
SUPPL-6 INFLIXIMAB-QBTX PFIZER INC Approval
01/15/2020 SIGNIFOR
NDA #200677
SUPPL-6 PASIREOTIDE DIASPARTATE NOVARTIS Efficacy Approval
01/15/2020 BOSENTAN
ANDA #205173
ORIG-1 BOSENTAN MYLAN Approval
01/15/2020 SUCCINYLCHOLINE CHLORIDE
ANDA #211589
ORIG-1 SUCCINYLCHOLINE CHLORIDE SOMERSET THERAPS LLC Approval
01/15/2020 LORATADINE
ANDA #211926
ORIG-1 LORATADINE STRIDES PHARMA Approval
01/16/2020 TYGACIL
NDA #021821
SUPPL-48 TIGECYCLINE PF PRISM CV Labeling Approval
01/16/2020 CALOMIST
NDA #022102
SUPPL-4 CYANOCOBALAMIN PAR PHARM Labeling Approval
01/16/2020 PERJETA
BLA #125409
SUPPL-124 PERTUZUMAB GENENTECH Approval
01/16/2020 MONOFERRIC
NDA #208171
ORIG-1 FERRIC DERISOMALTOSE PHARMACOSMOS AS Type 5 - New Formulation or New Manufacturer Approval
01/16/2020 BUPROPION HYDROCHLORIDE
ANDA #208606
ORIG-1 BUPROPION HYDROCHLORIDE CADILA PHARMS LTD Approval
01/16/2020 OZEMPIC
NDA #209637
SUPPL-3 SEMAGLUTIDE NOVO Efficacy Approval
01/16/2020 PHENYLEPHRINE HYDROCHLORIDE
ANDA #209967
ORIG-1 PHENYLEPHRINE HYDROCHLORIDE RICONPHARMA LLC Approval
01/16/2020 AMANTADINE
ANDA #211493
ORIG-1 AMANTADINE SANDOZ INC Tentative Approval
01/16/2020 RYBELSUS
NDA #213051
SUPPL-1 SEMAGLUTIDE NOVO Labeling Approval
01/16/2020 RYBELSUS
NDA #213182
ORIG-1 SEMAGLUTIDE NOVO NORDISK INC Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approval

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