| 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 |
ORBION PHARMS |
Labeling |
Approval |
| 01/02/2020 |
RASAGILINE MESYLATE
ANDA #201970 |
SUPPL-4 |
RASAGILINE MESYLATE |
ORBION PHARMS |
Labeling |
Approval |
| 01/02/2020 |
RASAGILINE MESYLATE
ANDA #201971 |
SUPPL-3 |
RASAGILINE MESYLATE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 01/02/2020 |
MESALAMINE
ANDA #210509 |
ORIG-1 |
MESALAMINE |
AMNEAL |
|
Approval |
| 01/02/2020 |
DEFERASIROX
ANDA #211641 |
ORIG-1 |
DEFERASIROX |
SUN PHARM |
|
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 |
ISOLOGIC INNOVATIVE |
Labeling |
Approval |
| 01/03/2020 |
DEFERASIROX
ANDA #209433 |
ORIG-1 |
DEFERASIROX |
ICHNOS |
|
Approval |
| 01/03/2020 |
BOSENTAN
ANDA #210342 |
ORIG-1 |
BOSENTAN |
CHARTWELL MOLECULAR |
|
Approval |
| 01/03/2020 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA #211729 |
ORIG-1 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
GRANULES |
|
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 |
PROVEPHARM SAS |
|
Approval |
| 01/08/2020 |
FUSILEV
NDA #020140 |
SUPPL-24 |
LEVOLEUCOVORIN CALCIUM |
ACROTECH BIOPHARMA |
Labeling |
Approval |
| 01/08/2020 |
GENOTROPIN
BLA #020280 |
SUPPL-90 |
SOMATROPIN |
PHARMACIA |
|
Approval |
| 01/08/2020 |
GENOTROPIN PRESERVATIVE FREE
BLA #020280 |
SUPPL-90 |
SOMATROPIN |
PHARMACIA |
|
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 BIOPHARMA |
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 |
UPSHER SMITH LABS |
|
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 |
CHARTWELL RX |
Labeling |
Approval |
| 01/09/2020 |
DIVALPROEX SODIUM
ANDA #077296 |
SUPPL-8 |
DIVALPROEX SODIUM |
CHARTWELL RX |
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 |
RISING |
|
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 |
Type 1 - New Molecular Entity |
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 |
TAKEDA PHARMS USA |
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 |
|
Approval |
| 01/10/2020 |
THIOTEPA
ANDA #208242 |
ORIG-1 |
THIOTEPA |
PENN LIFE |
|
Approval |
| 01/10/2020 |
NUMBRINO
NDA #209575 |
ORIG-1 |
COCAINE HYDROCHLORIDE |
OMNIVIUM PHARMS |
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 |
|
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 PHARMS LTD |
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 |
Labeling |
Approval |
| 01/13/2020 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202673 |
SUPPL-4 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TARO |
Labeling |
Approval |
| 01/13/2020 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202673 |
SUPPL-5 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TARO |
Labeling |
Approval |
| 01/13/2020 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202673 |
SUPPL-6 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TARO |
Labeling |
Approval |
| 01/13/2020 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #202673 |
SUPPL-7 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
TARO |
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 LIFESCIENCES |
Labeling |
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 |
|
Approval |
| 01/14/2020 |
HEPARIN SODIUM
NDA #017037 |
SUPPL-187 |
HEPARIN SODIUM |
HIKMA |
Manufacturing (CMC) |
Approval |
| 01/14/2020 |
DIVALPROEX SODIUM
ANDA #078790 |
SUPPL-15 |
DIVALPROEX SODIUM |
LUPIN |
Labeling |
Approval |
| 01/14/2020 |
DIVALPROEX SODIUM
ANDA #078790 |
SUPPL-16 |
DIVALPROEX SODIUM |
LUPIN |
Labeling |
Approval |
| 01/14/2020 |
DIVALPROEX SODIUM
ANDA #078790 |
SUPPL-17 |
DIVALPROEX SODIUM |
LUPIN |
Labeling |
Approval |
| 01/14/2020 |
DIVALPROEX SODIUM
ANDA #078790 |
SUPPL-18 |
DIVALPROEX SODIUM |
LUPIN |
Labeling |
Approval |
| 01/14/2020 |
DIVALPROEX SODIUM
ANDA #078790 |
SUPPL-19 |
DIVALPROEX SODIUM |
LUPIN |
Labeling |
Approval |
| 01/14/2020 |
DIVALPROEX SODIUM
ANDA #078790 |
SUPPL-20 |
DIVALPROEX SODIUM |
LUPIN |
Labeling |
Approval |
| 01/14/2020 |
DIVALPROEX SODIUM
ANDA #078790 |
SUPPL-21 |
DIVALPROEX SODIUM |
LUPIN |
Labeling |
Approval |
| 01/14/2020 |
DIVALPROEX SODIUM
ANDA #078790 |
SUPPL-22 |
DIVALPROEX SODIUM |
LUPIN |
Labeling |
Approval |
| 01/14/2020 |
DIVALPROEX SODIUM
ANDA #078790 |
SUPPL-23 |
DIVALPROEX SODIUM |
LUPIN |
Labeling |
Approval |
| 01/14/2020 |
DIVALPROEX SODIUM
ANDA #078790 |
SUPPL-24 |
DIVALPROEX SODIUM |
LUPIN |
Labeling |
Approval |
| 01/14/2020 |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #090513 |
SUPPL-10 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
AUROBINDO PHARMA |
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 |
|
Approval |
| 01/15/2020 |
LAMOTRIGINE
ANDA #090607 |
SUPPL-17 |
LAMOTRIGINE |
ALEMBIC PHARMS LTD |
Labeling |
Approval |
| 01/15/2020 |
LAMOTRIGINE
ANDA #090607 |
SUPPL-19 |
LAMOTRIGINE |
ALEMBIC PHARMS LTD |
Labeling |
Approval |
| 01/15/2020 |
LAMOTRIGINE
ANDA #090607 |
SUPPL-20 |
LAMOTRIGINE |
ALEMBIC PHARMS LTD |
Labeling |
Approval |
| 01/15/2020 |
SIGNIFOR
NDA #200677 |
SUPPL-6 |
PASIREOTIDE DIASPARTATE |
RECORDATI RARE |
Efficacy |
Approval |
| 01/15/2020 |
SILDENAFIL CITRATE
ANDA #202025 |
SUPPL-3 |
SILDENAFIL CITRATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 01/15/2020 |
SILDENAFIL CITRATE
ANDA #202025 |
SUPPL-4 |
SILDENAFIL CITRATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 01/15/2020 |
BOSENTAN
ANDA #205173 |
ORIG-1 |
BOSENTAN |
MYLAN |
|
Approval |
| 01/15/2020 |
ESOMEPRAZOLE MAGNESIUM
ANDA #209339 |
SUPPL-2 |
ESOMEPRAZOLE MAGNESIUM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/15/2020 |
ESOMEPRAZOLE MAGNESIUM
ANDA #209339 |
SUPPL-6 |
ESOMEPRAZOLE MAGNESIUM |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/15/2020 |
BOSUTINIB
ANDA #209624 |
ORIG-1 |
BOSUTINIB |
MSN LABORATORIES PRIVATE LTD |
|
Tentative Approval |
| 01/15/2020 |
DAPAGLIFLOZIN
ANDA #211470 |
ORIG-1 |
DAPAGLIFLOZIN |
BIOCON PHARMA LTD |
|
Tentative 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 |
DILAUDID
NDA #019034 |
SUPPL-37 |
HYDROMORPHONE HYDROCHLORIDE |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
| 01/16/2020 |
DILAUDID-HP
NDA #019034 |
SUPPL-37 |
HYDROMORPHONE HYDROCHLORIDE |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
| 01/16/2020 |
TYGACIL
NDA #021821 |
SUPPL-48 |
TIGECYCLINE |
PF PRISM CV |
Labeling |
Approval |
| 01/16/2020 |
CALOMIST
NDA #022102 |
SUPPL-4 |
CYANOCOBALAMIN |
ENDO OPERATIONS |
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 |
SAGENT PHARMS INC |
|
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 |
| 01/16/2020 |
IXIFI
BLA #761072 |
SUPPL-6 |
INFLIXIMAB-QBTX |
PFIZER INC |
|
Approval |
| 01/17/2020 |
OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN
NDA #050824 |
SUPPL-7 |
AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE |
CUMBERLAND |
Labeling |
Approval |
| 01/17/2020 |
ERYTHROMYCIN ETHYLSUCCINATE
ANDA #061904 |
SUPPL-23 |
ERYTHROMYCIN ETHYLSUCCINATE |
AZURITY |
Labeling |
Approval |
| 01/17/2020 |
ERYTHROMYCIN ETHYLSUCCINATE
ANDA #061904 |
SUPPL-25 |
ERYTHROMYCIN ETHYLSUCCINATE |
AZURITY |
Labeling |
Approval |
| 01/17/2020 |
LAMOTRIGINE
ANDA #090170 |
SUPPL-15 |
LAMOTRIGINE |
UNICHEM LABS LTD |
Labeling |
Approval |
| 01/17/2020 |
LAMOTRIGINE
ANDA #090170 |
SUPPL-21 |
LAMOTRIGINE |
UNICHEM LABS LTD |
Labeling |
Approval |
| 01/17/2020 |
LAMOTRIGINE
ANDA #090170 |
SUPPL-23 |
LAMOTRIGINE |
UNICHEM LABS LTD |
Labeling |
Approval |
| 01/17/2020 |
LAMOTRIGINE
ANDA #090170 |
SUPPL-25 |
LAMOTRIGINE |
UNICHEM LABS LTD |
Labeling |
Approval |
| 01/17/2020 |
BENLYSTA
BLA #125370 |
SUPPL-68 |
BELIMUMAB |
HUMAN GENOME SCIENCES INC. |
|
Approval |
| 01/17/2020 |
NALOXONE HYDROCHLORIDE
ANDA #211286 |
ORIG-1 |
NALOXONE HYDROCHLORIDE |
PAR STERILE PRODUCTS |
|
Approval |
| 01/17/2020 |
FENOFIBRATE
ANDA #213252 |
ORIG-1 |
FENOFIBRATE |
ALEMBIC |
|
Approval |
| 01/17/2020 |
CHLORPROMAZINE HYDROCHLORIDE
ANDA #213368 |
ORIG-1 |
CHLORPROMAZINE HYDROCHLORIDE |
ZYDUS |
|
Approval |
| 01/17/2020 |
BENLYSTA
BLA #761043 |
SUPPL-8 |
BELIMUMAB |
GLAXOSMITHKLINE LLC |
|
Approval |
| 01/21/2020 |
CYTOMEL
NDA #010379 |
SUPPL-57 |
LIOTHYRONINE SODIUM |
KING PHARMS |
Labeling |
Approval |
| 01/21/2020 |
SPECTAZOLE
NDA #018751 |
SUPPL-25 |
ECONAZOLE NITRATE |
ALVOGEN |
Labeling |
Approval |
| 01/21/2020 |
DESIPRAMINE HYDROCHLORIDE
ANDA #071588 |
SUPPL-31 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 01/21/2020 |
DESIPRAMINE HYDROCHLORIDE
ANDA #071601 |
SUPPL-32 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 01/21/2020 |
DESIPRAMINE HYDROCHLORIDE
ANDA #071602 |
SUPPL-29 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 01/21/2020 |
DESIPRAMINE HYDROCHLORIDE
ANDA #071766 |
SUPPL-30 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 01/21/2020 |
DESIPRAMINE HYDROCHLORIDE
ANDA #074430 |
SUPPL-19 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 01/21/2020 |
RISPERIDONE
ANDA #078269 |
SUPPL-12 |
RISPERIDONE |
RISING |
Labeling |
Approval |
| 01/21/2020 |
RISPERIDONE
ANDA #078269 |
SUPPL-13 |
RISPERIDONE |
RISING |
Labeling |
Approval |
| 01/21/2020 |
RISPERIDONE
ANDA #078269 |
SUPPL-14 |
RISPERIDONE |
RISING |
Labeling |
Approval |
| 01/21/2020 |
LAMOTRIGINE
ANDA #078691 |
SUPPL-5 |
LAMOTRIGINE |
LUPIN LTD |
Labeling |
Approval |
| 01/21/2020 |
LAMOTRIGINE
ANDA #078691 |
SUPPL-6 |
LAMOTRIGINE |
LUPIN LTD |
Labeling |
Approval |
| 01/21/2020 |
LAMOTRIGINE
ANDA #078691 |
SUPPL-7 |
LAMOTRIGINE |
LUPIN LTD |
Labeling |
Approval |
| 01/21/2020 |
LAMOTRIGINE
ANDA #078691 |
SUPPL-8 |
LAMOTRIGINE |
LUPIN LTD |
Labeling |
Approval |
| 01/21/2020 |
DIVALPROEX SODIUM
ANDA #078791 |
SUPPL-13 |
DIVALPROEX SODIUM |
IMPAX LABS |
Labeling |
Approval |
| 01/21/2020 |
DIVALPROEX SODIUM
ANDA #078791 |
SUPPL-14 |
DIVALPROEX SODIUM |
IMPAX LABS |
Labeling |
Approval |
| 01/21/2020 |
DIVALPROEX SODIUM
ANDA #078791 |
SUPPL-16 |
DIVALPROEX SODIUM |
IMPAX LABS |
Labeling |
Approval |
| 01/21/2020 |
DIVALPROEX SODIUM
ANDA #078791 |
SUPPL-18 |
DIVALPROEX SODIUM |
IMPAX LABS |
Labeling |
Approval |
| 01/21/2020 |
DIVALPROEX SODIUM
ANDA #078791 |
SUPPL-20 |
DIVALPROEX SODIUM |
IMPAX LABS |
Labeling |
Approval |
| 01/21/2020 |
DIVALPROEX SODIUM
ANDA #078979 |
SUPPL-18 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 01/21/2020 |
DIVALPROEX SODIUM
ANDA #078979 |
SUPPL-19 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 01/21/2020 |
DIVALPROEX SODIUM
ANDA #078979 |
SUPPL-20 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 01/21/2020 |
DIVALPROEX SODIUM
ANDA #078979 |
SUPPL-21 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 01/21/2020 |
DIVALPROEX SODIUM
ANDA #078979 |
SUPPL-22 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 01/21/2020 |
MONTELUKAST SODIUM
ANDA #090655 |
SUPPL-3 |
MONTELUKAST SODIUM |
HIKMA |
Labeling |
Approval |
| 01/21/2020 |
MONTELUKAST SODIUM
ANDA #090655 |
SUPPL-4 |
MONTELUKAST SODIUM |
HIKMA |
Labeling |
Approval |
| 01/21/2020 |
MONTELUKAST SODIUM
ANDA #090655 |
SUPPL-5 |
MONTELUKAST SODIUM |
HIKMA |
Labeling |
Approval |
| 01/21/2020 |
MONTELUKAST SODIUM
ANDA #091128 |
SUPPL-3 |
MONTELUKAST SODIUM |
HIKMA |
Labeling |
Approval |
| 01/21/2020 |
MONTELUKAST SODIUM
ANDA #091128 |
SUPPL-4 |
MONTELUKAST SODIUM |
HIKMA |
Labeling |
Approval |
| 01/21/2020 |
MONTELUKAST SODIUM
ANDA #091128 |
SUPPL-5 |
MONTELUKAST SODIUM |
HIKMA |
Labeling |
Approval |
| 01/21/2020 |
TOBRAMYCIN
ANDA #201422 |
SUPPL-1 |
TOBRAMYCIN |
HIKMA |
Labeling |
Approval |
| 01/21/2020 |
TOBRAMYCIN
ANDA #201422 |
SUPPL-3 |
TOBRAMYCIN |
HIKMA |
Labeling |
Approval |
| 01/21/2020 |
TOBRAMYCIN
ANDA #201422 |
SUPPL-4 |
TOBRAMYCIN |
HIKMA |
Labeling |
Approval |
| 01/21/2020 |
HYDROCODONE BITARTRATE
ANDA #206986 |
ORIG-1 |
HYDROCODONE BITARTRATE |
ALVOGEN |
|
Approval |
| 01/21/2020 |
ESOMEPRAZOLE MAGNESIUM
ANDA #207193 |
SUPPL-3 |
ESOMEPRAZOLE MAGNESIUM |
PERRIGO R AND D |
Labeling |
Approval |
| 01/21/2020 |
ESOMEPRAZOLE MAGNESIUM
ANDA #207193 |
SUPPL-11 |
ESOMEPRAZOLE MAGNESIUM |
PERRIGO R AND D |
Labeling |
Approval |
| 01/21/2020 |
ESOMEPRAZOLE MAGNESIUM
ANDA #207673 |
SUPPL-3 |
ESOMEPRAZOLE MAGNESIUM |
DR REDDYS |
Labeling |
Approval |
| 01/21/2020 |
AZITHROMYCIN
ANDA #209044 |
SUPPL-4 |
AZITHROMYCIN |
SUNSHINE |
Manufacturing (CMC) |
Approval |
| 01/21/2020 |
AZITHROMYCIN
ANDA #209045 |
SUPPL-4 |
AZITHROMYCIN |
SUNSHINE |
Manufacturing (CMC) |
Approval |
| 01/21/2020 |
KISQALI
NDA #209092 |
SUPPL-3 |
RIBOCICLIB SUCCINATE |
NOVARTIS |
Labeling |
Approval |
| 01/21/2020 |
KISQALI FEMARA CO-PACK (COPACKAGED)
NDA #209935 |
SUPPL-6 |
LETROZOLE; RIBOCICLIB SUCCINATE |
NOVARTIS |
Labeling |
Approval |
| 01/21/2020 |
BIMATOPROST
ANDA #210515 |
ORIG-1 |
BIMATOPROST |
ALEMBIC |
|
Approval |
| 01/21/2020 |
TEPEZZA
BLA #761143 |
ORIG-1 |
TEPROTUMUMAB-TRBW |
HORIZON THERAPEUTICS IRELAND |
|
Approval |
| 01/22/2020 |
AFINITOR
NDA #022334 |
SUPPL-45 |
EVEROLIMUS |
NOVARTIS |
Labeling |
Approval |
| 01/22/2020 |
EMTRICITABINE
ANDA #091168 |
SUPPL-7 |
EMTRICITABINE |
CIPLA |
Labeling |
Approval |
| 01/22/2020 |
JENCYCLA
ANDA #091323 |
SUPPL-6 |
NORETHINDRONE |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
| 01/22/2020 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #200248 |
SUPPL-7 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
| 01/22/2020 |
ZIDOVUDINE
ANDA #202058 |
SUPPL-9 |
ZIDOVUDINE |
HEC PHARM |
Labeling |
Approval |
| 01/22/2020 |
ZIDOVUDINE
ANDA #202058 |
SUPPL-14 |
ZIDOVUDINE |
HEC PHARM |
Labeling |
Approval |
| 01/22/2020 |
RIZATRIPTAN BENZOATE
ANDA #203269 |
SUPPL-3 |
RIZATRIPTAN BENZOATE |
ALKEM LABS LTD |
Labeling |
Approval |
| 01/22/2020 |
RIZATRIPTAN BENZOATE
ANDA #203269 |
SUPPL-4 |
RIZATRIPTAN BENZOATE |
ALKEM LABS LTD |
Labeling |
Approval |
| 01/22/2020 |
AFINITOR DISPERZ
NDA #203985 |
SUPPL-17 |
EVEROLIMUS |
NOVARTIS PHARM |
Labeling |
Approval |
| 01/22/2020 |
RANOLAZINE
ANDA #210188 |
SUPPL-2 |
RANOLAZINE |
CADILA |
Labeling |
Approval |
| 01/22/2020 |
RANOLAZINE
ANDA #210482 |
SUPPL-1 |
RANOLAZINE |
ANI PHARMS |
Labeling |
Approval |
| 01/22/2020 |
RANOLAZINE
ANDA #211291 |
SUPPL-2 |
RANOLAZINE |
CIPLA |
Labeling |
Approval |
| 01/22/2020 |
TETRABENAZINE
ANDA #213316 |
ORIG-1 |
TETRABENAZINE |
SLATE RUN PHARMA |
|
Approval |
| 01/23/2020 |
OPTIRAY 160
NDA #019710 |
SUPPL-58 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 01/23/2020 |
OPTIRAY 240
NDA #019710 |
SUPPL-58 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 01/23/2020 |
OPTIRAY 300
NDA #019710 |
SUPPL-58 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 01/23/2020 |
OPTIRAY 320
NDA #019710 |
SUPPL-58 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 01/23/2020 |
OPTIRAY 350
NDA #019710 |
SUPPL-58 |
IOVERSOL |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
| 01/23/2020 |
GEODON
NDA #020825 |
SUPPL-58 |
ZIPRASIDONE HYDROCHLORIDE |
VIATRIS |
Labeling |
Approval |
| 01/23/2020 |
GEODON
NDA #020919 |
SUPPL-45 |
ZIPRASIDONE MESYLATE |
VIATRIS |
Labeling |
Approval |
| 01/23/2020 |
TENOFOVIR DISOPROXIL FUMARATE
ANDA #090636 |
SUPPL-9 |
TENOFOVIR DISOPROXIL FUMARATE |
HETERO LABS LTD III |
Labeling |
Approval |
| 01/23/2020 |
RITUXAN
BLA #103705 |
SUPPL-5461 |
RITUXIMAB |
GENENTECH |
|
Approval |
| 01/23/2020 |
INLYTA
NDA #202324 |
SUPPL-10 |
AXITINIB |
PF PRISM CV |
Labeling |
Approval |
| 01/23/2020 |
AZITHROMYCIN
ANDA #209201 |
SUPPL-2 |
AZITHROMYCIN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/23/2020 |
QUETIAPINE FUMARATE
ANDA #209497 |
SUPPL-1 |
QUETIAPINE FUMARATE |
ALIGNSCIENCE PHARMA |
Labeling |
Approval |
| 01/23/2020 |
QUETIAPINE FUMARATE
ANDA #209497 |
SUPPL-2 |
QUETIAPINE FUMARATE |
ALIGNSCIENCE PHARMA |
Labeling |
Approval |
| 01/23/2020 |
POTASSIUM CHLORIDE
ANDA #210200 |
SUPPL-2 |
POTASSIUM CHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 01/23/2020 |
POTASSIUM CHLORIDE
ANDA #210902 |
SUPPL-1 |
POTASSIUM CHLORIDE |
AMNEAL |
Labeling |
Approval |
| 01/23/2020 |
BOSENTAN
ANDA #211461 |
ORIG-1 |
BOSENTAN |
ALEMBIC |
|
Approval |
| 01/23/2020 |
TAZVERIK
NDA #211723 |
ORIG-1 |
TAZEMETOSTAT HYDROBROMIDE |
EPIZYME INC |
Type 1 - New Molecular Entity |
Approval |
| 01/24/2020 |
NAVELBINE
NDA #020388 |
SUPPL-37 |
VINORELBINE TARTRATE |
PIERRE FABRE |
Labeling |
Approval |
| 01/24/2020 |
SABRIL
NDA #020427 |
SUPPL-21 |
VIGABATRIN |
LUNDBECK PHARMS LLC |
Efficacy |
Approval |
| 01/24/2020 |
ABSORICA
NDA #021951 |
SUPPL-15 |
ISOTRETINOIN |
SUN PHARM INDS INC |
REMS |
Approval |
| 01/24/2020 |
SABRIL
NDA #022006 |
SUPPL-23 |
VIGABATRIN |
LUNDBECK PHARMS LLC |
Efficacy |
Approval |
| 01/24/2020 |
DIFICID
NDA #201699 |
SUPPL-12 |
FIDAXOMICIN |
CUBIST PHARMS LLC |
Efficacy |
Approval |
| 01/24/2020 |
FARXIGA
NDA #202293 |
SUPPL-21 |
DAPAGLIFLOZIN |
ASTRAZENECA AB |
Labeling |
Approval |
| 01/24/2020 |
EZETIMIBE AND SIMVASTATIN
ANDA #202968 |
SUPPL-4 |
EZETIMIBE; SIMVASTATIN |
WATSON LABS INC |
Labeling |
Approval |
| 01/24/2020 |
INVOKANA
NDA #204042 |
SUPPL-36 |
CANAGLIFLOZIN |
JANSSEN PHARMS |
Labeling |
Approval |
| 01/24/2020 |
INVOKAMET
NDA #204353 |
SUPPL-36 |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
JANSSEN PHARMS |
Labeling |
Approval |
| 01/24/2020 |
JARDIANCE
NDA #204629 |
SUPPL-23 |
EMPAGLIFLOZIN |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 01/24/2020 |
TOLTERODINE TARTRATE
ANDA #204721 |
ORIG-1 |
TOLTERODINE TARTRATE |
UNIQUE |
|
Approval |
| 01/24/2020 |
XIGDUO XR
NDA #205649 |
SUPPL-13 |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
ASTRAZENECA AB |
Labeling |
Approval |
| 01/24/2020 |
INVOKAMET XR
NDA #205879 |
SUPPL-14 |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
JANSSEN PHARMS |
Labeling |
Approval |
| 01/24/2020 |
GLYXAMBI
NDA #206073 |
SUPPL-23 |
EMPAGLIFLOZIN; LINAGLIPTIN |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 01/24/2020 |
SYNJARDY
NDA #206111 |
SUPPL-22 |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 01/24/2020 |
SYNJARDY XR
NDA #208658 |
SUPPL-9 |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 01/24/2020 |
EZETIMIBE AND SIMVASTATIN
ANDA #208699 |
SUPPL-1 |
EZETIMIBE; SIMVASTATIN |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/24/2020 |
QTERN
NDA #209091 |
SUPPL-5 |
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE |
ASTRAZENECA AB |
Labeling |
Approval |
| 01/24/2020 |
STEGLATRO
NDA #209803 |
SUPPL-2 |
ERTUGLIFLOZIN |
MSD SUB MERCK |
Labeling |
Approval |
| 01/24/2020 |
STEGLUJAN
NDA #209805 |
SUPPL-6 |
ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE |
MSD SUB MERCK |
Labeling |
Approval |
| 01/24/2020 |
SEGLUROMET
NDA #209806 |
SUPPL-2 |
ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE |
MSD SUB MERCK |
Labeling |
Approval |
| 01/24/2020 |
QTERNMET XR
NDA #210874 |
SUPPL-3 |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
ASTRAZENECA AB |
Labeling |
Approval |
| 01/24/2020 |
RANOLAZINE
ANDA #211829 |
SUPPL-4 |
RANOLAZINE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 01/24/2020 |
RANOLAZINE
ANDA #211829 |
SUPPL-5 |
RANOLAZINE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 01/24/2020 |
DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #213034 |
ORIG-1 |
DROSPIRENONE; ETHINYL ESTRADIOL |
HETERO LABS |
|
Approval |
| 01/24/2020 |
DIFICID
NDA #213138 |
ORIG-1 |
FIDAXOMICIN |
CUBIST PHARMS LLC |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 01/24/2020 |
METHOTREXATE SODIUM
ANDA #213343 |
ORIG-1 |
METHOTREXATE SODIUM |
ACCORD HLTHCARE |
|
Approval |
| 01/24/2020 |
TRAZIMERA
BLA #761081 |
SUPPL-2 |
TRASTUZUMAB-QYYP |
PFIZER INC |
|
Approval |
| 01/27/2020 |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #020178 |
SUPPL-23 |
SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 01/27/2020 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065358 |
SUPPL-10 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
SANDOZ INC |
Labeling |
Approval |
| 01/27/2020 |
EPIRUBICIN HYDROCHLORIDE
ANDA #065361 |
SUPPL-6 |
EPIRUBICIN HYDROCHLORIDE |
CIPLA LTD |
Labeling |
Approval |
| 01/27/2020 |
EPIRUBICIN HYDROCHLORIDE
ANDA #065361 |
SUPPL-11 |
EPIRUBICIN HYDROCHLORIDE |
CIPLA LTD |
Labeling |
Approval |
| 01/27/2020 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #065373 |
SUPPL-14 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
HIKMA PHARMS |
Labeling |
Approval |
| 01/27/2020 |
AZITHROMYCIN
ANDA #065500 |
SUPPL-7 |
AZITHROMYCIN |
HOSPIRA |
Labeling |
Approval |
| 01/27/2020 |
AZITHROMYCIN
ANDA #065500 |
SUPPL-8 |
AZITHROMYCIN |
HOSPIRA |
Labeling |
Approval |
| 01/27/2020 |
AZITHROMYCIN
ANDA #065500 |
SUPPL-13 |
AZITHROMYCIN |
HOSPIRA |
Labeling |
Approval |
| 01/27/2020 |
AZITHROMYCIN
ANDA #065501 |
SUPPL-8 |
AZITHROMYCIN |
GLAND PHARMA LTD |
Labeling |
Approval |
| 01/27/2020 |
AZITHROMYCIN
ANDA #065501 |
SUPPL-9 |
AZITHROMYCIN |
GLAND PHARMA LTD |
Labeling |
Approval |
| 01/27/2020 |
AZITHROMYCIN
ANDA #065501 |
SUPPL-12 |
AZITHROMYCIN |
GLAND PHARMA LTD |
Labeling |
Approval |
| 01/27/2020 |
AZITHROMYCIN
ANDA #065511 |
SUPPL-6 |
AZITHROMYCIN |
HOSPIRA |
Labeling |
Approval |
| 01/27/2020 |
AZITHROMYCIN
ANDA #065511 |
SUPPL-7 |
AZITHROMYCIN |
HOSPIRA |
Labeling |
Approval |
| 01/27/2020 |
AZITHROMYCIN
ANDA #065511 |
SUPPL-10 |
AZITHROMYCIN |
HOSPIRA |
Labeling |
Approval |
| 01/27/2020 |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #203041 |
SUPPL-8 |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/27/2020 |
AZITHROMYCIN
ANDA #203294 |
SUPPL-2 |
AZITHROMYCIN |
EUGIA PHARMA |
Labeling |
Approval |
| 01/27/2020 |
AZITHROMYCIN
ANDA #203294 |
SUPPL-3 |
AZITHROMYCIN |
EUGIA PHARMA |
Labeling |
Approval |
| 01/27/2020 |
AZITHROMYCIN
ANDA #203294 |
SUPPL-6 |
AZITHROMYCIN |
EUGIA PHARMA |
Labeling |
Approval |
| 01/27/2020 |
TRAVOPROST
ANDA #203431 |
SUPPL-1 |
TRAVOPROST |
APOTEX |
Labeling |
Approval |
| 01/27/2020 |
TRAVOPROST
ANDA #203431 |
SUPPL-5 |
TRAVOPROST |
APOTEX |
Manufacturing (CMC) |
Approval |
| 01/27/2020 |
INVOKAMET
NDA #204353 |
SUPPL-33 |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
JANSSEN PHARMS |
Efficacy |
Approval |
| 01/27/2020 |
ZOLMITRIPTAN
ANDA #205074 |
SUPPL-5 |
ZOLMITRIPTAN |
ALEMBIC |
Labeling |
Approval |
| 01/27/2020 |
INVOKAMET XR
NDA #205879 |
SUPPL-11 |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
JANSSEN PHARMS |
Efficacy |
Approval |
| 01/27/2020 |
ILOPERIDONE
ANDA #207231 |
SUPPL-1 |
ILOPERIDONE |
INVENTIA |
Labeling |
Approval |
| 01/27/2020 |
QUETIAPINE FUMARATE
ANDA #209635 |
SUPPL-3 |
QUETIAPINE FUMARATE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 01/27/2020 |
QUETIAPINE FUMARATE
ANDA #209635 |
SUPPL-6 |
QUETIAPINE FUMARATE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 01/27/2020 |
SODIUM OXYBATE
ANDA #210936 |
ORIG-1 |
SODIUM OXYBATE |
SPECGX LLC |
|
Tentative Approval |
| 01/27/2020 |
DICLOFENAC SODIUM
ANDA #210986 |
ORIG-1 |
DICLOFENAC SODIUM |
ENCUBE |
|
Approval |
| 01/27/2020 |
AZITHROMYCIN
ANDA #211793 |
ORIG-1 |
AZITHROMYCIN |
ALEMBIC |
|
Approval |
| 01/27/2020 |
OXYCODONE HYDROCHLORIDE
ANDA #212429 |
ORIG-1 |
OXYCODONE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
|
Approval |
| 01/27/2020 |
TRIJARDY XR
NDA #212614 |
ORIG-1 |
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Type 4 - New Combination |
Approval |
| 01/27/2020 |
CLOBETASOL PROPIONATE
ANDA #213291 |
ORIG-1 |
CLOBETASOL PROPIONATE |
ALEMBIC |
|
Approval |
| 01/27/2020 |
AJOVY
BLA #761089 |
SUPPL-2 |
FREMANEZUMAB-VFRM |
TEVA PHARMS USA |
|
Approval |
| 01/28/2020 |
MONISTAT 7
NDA #017450 |
SUPPL-73 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Labeling |
Approval |
| 01/28/2020 |
CEREBYX
NDA #020450 |
SUPPL-40 |
FOSPHENYTOIN SODIUM |
PARKE DAVIS |
Labeling |
Approval |
| 01/28/2020 |
MONISTAT 3 COMBINATION PACK
NDA #020670 |
SUPPL-35 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Labeling |
Approval |
| 01/28/2020 |
MONISTAT 3
NDA #020827 |
SUPPL-31 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Labeling |
Approval |
| 01/28/2020 |
REBETOL
NDA #020903 |
SUPPL-56 |
RIBAVIRIN |
MERCK SHARP DOHME |
Labeling |
Approval |
| 01/28/2020 |
MONISTAT 3 COMBINATION PACK
NDA #021261 |
SUPPL-24 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Labeling |
Approval |
| 01/28/2020 |
MONISTAT 3 COMBINATION PACK (PREFILLED)
NDA #021261 |
SUPPL-24 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Labeling |
Approval |
| 01/28/2020 |
MONISTAT 1 COMBINATION PACK
NDA #021308 |
SUPPL-30 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Labeling |
Approval |
| 01/28/2020 |
REBETOL
NDA #021546 |
SUPPL-12 |
RIBAVIRIN |
SCHERING |
Labeling |
Approval |
| 01/28/2020 |
PANCREAZE
BLA #022523 |
SUPPL-14 |
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) |
VIVUS INC |
|
Approval |
| 01/28/2020 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077732 |
SUPPL-9 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
HIKMA |
Labeling |
Approval |
| 01/28/2020 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #077732 |
SUPPL-10 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
HIKMA |
Labeling |
Approval |
| 01/28/2020 |
TOPOTECAN HYDROCHLORIDE
ANDA #201166 |
SUPPL-2 |
TOPOTECAN HYDROCHLORIDE |
MEITHEAL |
Labeling |
Approval |
| 01/28/2020 |
TOPOTECAN HYDROCHLORIDE
ANDA #201166 |
SUPPL-3 |
TOPOTECAN HYDROCHLORIDE |
MEITHEAL |
Labeling |
Approval |
| 01/28/2020 |
OLOPATADINE HYDROCHLORIDE
ANDA #210901 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
AMNEAL |
|
Approval |
| 01/28/2020 |
AZITHROMYCIN
ANDA #211791 |
ORIG-1 |
AZITHROMYCIN |
ALEMBIC |
|
Approval |
| 01/28/2020 |
AZITHROMYCIN
ANDA #211792 |
ORIG-1 |
AZITHROMYCIN |
ALEMBIC |
|
Approval |
| 01/29/2020 |
DERMA-SMOOTHE/FS
NDA #019452 |
SUPPL-40 |
FLUOCINOLONE ACETONIDE |
HILL DERMAC |
Labeling |
Approval |
| 01/29/2020 |
DERMOTIC
NDA #019452 |
SUPPL-40 |
FLUOCINOLONE ACETONIDE |
HILL DERMAC |
Labeling |
Approval |
| 01/29/2020 |
RIZATRIPTAN BENZOATE
ANDA #077526 |
SUPPL-2 |
RIZATRIPTAN BENZOATE |
CHARTWELL RX |
Labeling |
Approval |
| 01/29/2020 |
LAMOTRIGINE
ANDA #078525 |
SUPPL-14 |
LAMOTRIGINE |
TARO PHARM INDS |
Labeling |
Approval |
| 01/29/2020 |
LAMOTRIGINE
ANDA #078525 |
SUPPL-15 |
LAMOTRIGINE |
TARO PHARM INDS |
Labeling |
Approval |
| 01/29/2020 |
LAMOTRIGINE
ANDA #078525 |
SUPPL-16 |
LAMOTRIGINE |
TARO PHARM INDS |
Labeling |
Approval |
| 01/29/2020 |
LAMOTRIGINE
ANDA #078525 |
SUPPL-23 |
LAMOTRIGINE |
TARO PHARM INDS |
Labeling |
Approval |
| 01/29/2020 |
LAMOTRIGINE
ANDA #078525 |
SUPPL-25 |
LAMOTRIGINE |
TARO PHARM INDS |
Labeling |
Approval |
| 01/29/2020 |
LAMOTRIGINE
ANDA #078625 |
SUPPL-10 |
LAMOTRIGINE |
RUBICON |
Labeling |
Approval |
| 01/29/2020 |
LAMOTRIGINE
ANDA #078625 |
SUPPL-11 |
LAMOTRIGINE |
RUBICON |
Labeling |
Approval |
| 01/29/2020 |
LAMOTRIGINE
ANDA #078625 |
SUPPL-12 |
LAMOTRIGINE |
RUBICON |
Labeling |
Approval |
| 01/29/2020 |
COSENTYX
BLA #125504 |
SUPPL-31 |
SECUKINUMAB |
NOVARTIS PHARMS CORP |
|
Approval |
| 01/29/2020 |
LAMOTRIGINE
ANDA #200828 |
SUPPL-4 |
LAMOTRIGINE |
IMPAX LABS INC |
Labeling |
Approval |
| 01/29/2020 |
LAMOTRIGINE
ANDA #200828 |
SUPPL-6 |
LAMOTRIGINE |
IMPAX LABS INC |
Labeling |
Approval |
| 01/29/2020 |
LAMOTRIGINE
ANDA #200828 |
SUPPL-7 |
LAMOTRIGINE |
IMPAX LABS INC |
Labeling |
Approval |
| 01/29/2020 |
EZETIMIBE AND SIMVASTATIN
ANDA #200909 |
SUPPL-2 |
EZETIMIBE; SIMVASTATIN |
DR REDDYS LABS SA |
Labeling |
Approval |
| 01/29/2020 |
ACYCLOVIR
ANDA #201501 |
ORIG-1 |
ACYCLOVIR |
XIROMED |
|
Approval |
| 01/29/2020 |
EZETIMIBE AND SIMVASTATIN
ANDA #201890 |
SUPPL-8 |
EZETIMIBE; SIMVASTATIN |
ANI PHARMS |
Labeling |
Approval |
| 01/29/2020 |
EZETIMIBE AND SIMVASTATIN
ANDA #201890 |
SUPPL-9 |
EZETIMIBE; SIMVASTATIN |
ANI PHARMS |
Labeling |
Approval |
| 01/29/2020 |
RIZATRIPTAN BENZOATE
ANDA #201914 |
SUPPL-4 |
RIZATRIPTAN BENZOATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/29/2020 |
RIZATRIPTAN BENZOATE
ANDA #201914 |
SUPPL-5 |
RIZATRIPTAN BENZOATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/29/2020 |
RIZATRIPTAN BENZOATE
ANDA #203062 |
SUPPL-5 |
RIZATRIPTAN BENZOATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/29/2020 |
BELSOMRA
NDA #204569 |
SUPPL-6 |
SUVOREXANT |
MERCK SHARP DOHME |
Efficacy |
Approval |
| 01/29/2020 |
LAMOTRIGINE
ANDA #206382 |
SUPPL-3 |
LAMOTRIGINE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 01/29/2020 |
LAMOTRIGINE
ANDA #206382 |
SUPPL-6 |
LAMOTRIGINE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 01/29/2020 |
LAMOTRIGINE
ANDA #206382 |
SUPPL-7 |
LAMOTRIGINE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 01/29/2020 |
TESTOSTERONE
ANDA #208061 |
SUPPL-4 |
TESTOSTERONE |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
| 01/29/2020 |
EZETIMIBE AND SIMVASTATIN
ANDA #208831 |
SUPPL-4 |
EZETIMIBE; SIMVASTATIN |
AMNEAL PHARMS CO |
Labeling |
Approval |
| 01/29/2020 |
EZETIMIBE AND SIMVASTATIN
ANDA #209222 |
SUPPL-6 |
EZETIMIBE; SIMVASTATIN |
ALKEM LABS LTD |
Labeling |
Approval |
| 01/29/2020 |
RANOLAZINE
ANDA #211082 |
SUPPL-1 |
RANOLAZINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/29/2020 |
RANOLAZINE
ANDA #211082 |
SUPPL-2 |
RANOLAZINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/29/2020 |
DOFETILIDE
ANDA #213220 |
ORIG-1 |
DOFETILIDE |
MSN |
|
Approval |
| 01/30/2020 |
CAMPTOSAR
NDA #020571 |
SUPPL-51 |
IRINOTECAN HYDROCHLORIDE |
PFIZER INC |
Labeling |
Approval |
| 01/30/2020 |
MIRAPEX
NDA #020667 |
SUPPL-39 |
PRAMIPEXOLE DIHYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 01/30/2020 |
PRILOSEC OTC
NDA #021229 |
SUPPL-34 |
OMEPRAZOLE MAGNESIUM |
ASTRAZENECA |
Labeling |
Approval |
| 01/30/2020 |
AVODART
NDA #021319 |
SUPPL-32 |
DUTASTERIDE |
WAYLIS THERAP |
Labeling |
Approval |
| 01/30/2020 |
MIRAPEX ER
NDA #022421 |
SUPPL-20 |
PRAMIPEXOLE DIHYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 01/30/2020 |
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER
NDA #065430 |
SUPPL-9 |
CEFOTETAN DISODIUM |
B BRAUN |
Labeling |
Approval |
| 01/30/2020 |
LAMOTRIGINE
ANDA #076928 |
SUPPL-15 |
LAMOTRIGINE |
WATSON LABS |
Labeling |
Approval |
| 01/30/2020 |
LAMOTRIGINE
ANDA #076928 |
SUPPL-16 |
LAMOTRIGINE |
WATSON LABS |
Labeling |
Approval |
| 01/30/2020 |
DIVALPROEX SODIUM
ANDA #078597 |
SUPPL-14 |
DIVALPROEX SODIUM |
SUN PHARM INDS |
Labeling |
Approval |
| 01/30/2020 |
DIVALPROEX SODIUM
ANDA #078597 |
SUPPL-15 |
DIVALPROEX SODIUM |
SUN PHARM INDS |
Labeling |
Approval |
| 01/30/2020 |
DIVALPROEX SODIUM
ANDA #078597 |
SUPPL-16 |
DIVALPROEX SODIUM |
SUN PHARM INDS |
Labeling |
Approval |
| 01/30/2020 |
DIVALPROEX SODIUM
ANDA #078597 |
SUPPL-18 |
DIVALPROEX SODIUM |
SUN PHARM INDS |
Labeling |
Approval |
| 01/30/2020 |
DIVALPROEX SODIUM
ANDA #078597 |
SUPPL-19 |
DIVALPROEX SODIUM |
SUN PHARM INDS |
Labeling |
Approval |
| 01/30/2020 |
DIVALPROEX SODIUM
ANDA #078597 |
SUPPL-20 |
DIVALPROEX SODIUM |
SUN PHARM INDS |
Labeling |
Approval |
| 01/30/2020 |
DIVALPROEX SODIUM
ANDA #078597 |
SUPPL-22 |
DIVALPROEX SODIUM |
SUN PHARM INDS |
Labeling |
Approval |
| 01/30/2020 |
DIVALPROEX SODIUM
ANDA #078597 |
SUPPL-25 |
DIVALPROEX SODIUM |
SUN PHARM INDS |
Labeling |
Approval |
| 01/30/2020 |
DIVALPROEX SODIUM
ANDA #078597 |
SUPPL-28 |
DIVALPROEX SODIUM |
SUN PHARM INDS |
Labeling |
Approval |
| 01/30/2020 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #206407 |
ORIG-1 |
DEXMEDETOMIDINE HYDROCHLORIDE |
HIKMA |
|
Approval |
| 01/30/2020 |
POTASSIUM CHLORIDE
ANDA #209786 |
SUPPL-2 |
POTASSIUM CHLORIDE |
NOVEL LABS INC |
Labeling |
Approval |
| 01/30/2020 |
METHOTREXATE SODIUM
ANDA #210454 |
ORIG-1 |
METHOTREXATE SODIUM |
EUGIA PHARMA |
|
Approval |
| 01/30/2020 |
POTASSIUM CHLORIDE
ANDA #211067 |
SUPPL-1 |
POTASSIUM CHLORIDE |
APOTEX |
Labeling |
Approval |
| 01/30/2020 |
PIRFENIDONE
ANDA #212606 |
ORIG-1 |
PIRFENIDONE |
SHILPA MEDICARE |
|
Tentative Approval |
| 01/31/2020 |
EPI E Z PEN JR
NDA #019430 |
SUPPL-82 |
EPINEPHRINE |
MYLAN SPECIALITY LP |
Labeling |
Approval |
| 01/31/2020 |
EPIPEN
NDA #019430 |
SUPPL-82 |
EPINEPHRINE |
MYLAN SPECIALITY LP |
Labeling |
Approval |
| 01/31/2020 |
EPIPEN E Z PEN
NDA #019430 |
SUPPL-82 |
EPINEPHRINE |
MYLAN SPECIALITY LP |
Labeling |
Approval |
| 01/31/2020 |
EPIPEN JR.
NDA #019430 |
SUPPL-82 |
EPINEPHRINE |
MYLAN SPECIALITY LP |
Labeling |
Approval |
| 01/31/2020 |
PRECEDEX
NDA #021038 |
SUPPL-35 |
DEXMEDETOMIDINE HYDROCHLORIDE |
HOSPIRA |
Manufacturing (CMC) |
Approval |
| 01/31/2020 |
MUCINEX DM
NDA #021620 |
SUPPL-40 |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
RB HLTH |
Manufacturing (CMC) |
Approval |
| 01/31/2020 |
MEN'S ROGAINE
NDA #021812 |
SUPPL-15 |
MINOXIDIL |
JOHNSON AND JOHNSON |
Labeling |
Approval |
| 01/31/2020 |
WOMEN'S ROGAINE
NDA #021812 |
SUPPL-15 |
MINOXIDIL |
JOHNSON AND JOHNSON |
Labeling |
Approval |
| 01/31/2020 |
VIIBRYD
NDA #022567 |
SUPPL-21 |
VILAZODONE HYDROCHLORIDE |
ABBVIE |
Efficacy |
Approval |
| 01/31/2020 |
COMETRIQ
NDA #203756 |
SUPPL-8 |
CABOZANTINIB S-MALATE |
EXELIXIS |
Labeling |
Approval |
| 01/31/2020 |
CABOMETYX
NDA #208692 |
SUPPL-7 |
CABOZANTINIB S-MALATE |
EXELIXIS INC |
Labeling |
Approval |
| 01/31/2020 |
AMMONIA N 13
ANDA #210524 |
SUPPL-1 |
AMMONIA N-13 |
IONETIX |
Manufacturing (CMC) |
Approval |
| 01/31/2020 |
DOLUTEGRAVIR
ANDA #210900 |
ORIG-1 |
DOLUTEGRAVIR |
LAURUS LABS LTD |
|
Tentative Approval |
| 01/31/2020 |
CLOBAZAM
ANDA #211032 |
ORIG-1 |
CLOBAZAM |
TEVA PHARMS USA |
|
Approval |
| 01/31/2020 |
VALGANCICLOVIR HYDROCHLORIDE
ANDA #213306 |
ORIG-1 |
VALGANCICLOVIR HYDROCHLORIDE |
GRANULES |
|
Approval |
