| 07/01/2020 |
PRADAXA
NDA #022512 |
SUPPL-39 |
DABIGATRAN ETEXILATE MESYLATE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 07/01/2020 |
RIFAMPIN
ANDA #065421 |
SUPPL-8 |
RIFAMPIN |
MYLAN LABS LTD |
Labeling |
Approval |
| 07/01/2020 |
RIFAMPIN
ANDA #065421 |
SUPPL-9 |
RIFAMPIN |
MYLAN LABS LTD |
Labeling |
Approval |
| 07/01/2020 |
RIFAMPIN
ANDA #065421 |
SUPPL-14 |
RIFAMPIN |
MYLAN LABS LTD |
Labeling |
Approval |
| 07/01/2020 |
BUMETANIDE
ANDA #074332 |
SUPPL-15 |
BUMETANIDE |
HOSPIRA |
Labeling |
Approval |
| 07/01/2020 |
SUMATRIPTAN SUCCINATE
ANDA #076847 |
SUPPL-5 |
SUMATRIPTAN SUCCINATE |
DR REDDYS LABS INC |
Labeling |
Approval |
| 07/01/2020 |
SUMATRIPTAN SUCCINATE
ANDA #076847 |
SUPPL-6 |
SUMATRIPTAN SUCCINATE |
DR REDDYS LABS INC |
Labeling |
Approval |
| 07/01/2020 |
NATPARA
BLA #125511 |
SUPPL-20 |
PARATHYROID HORMONE |
NPS PHARMS INC |
|
Approval |
| 07/01/2020 |
RIFAMPIN
ANDA #205039 |
SUPPL-1 |
RIFAMPIN |
HIKMA PHARMS |
Labeling |
Approval |
| 07/01/2020 |
RIFAMPIN
ANDA #205039 |
SUPPL-2 |
RIFAMPIN |
HIKMA PHARMS |
Labeling |
Approval |
| 07/01/2020 |
RIFAMPIN
ANDA #205039 |
SUPPL-3 |
RIFAMPIN |
HIKMA PHARMS |
Labeling |
Approval |
| 07/01/2020 |
RIFAMPIN
ANDA #205039 |
SUPPL-4 |
RIFAMPIN |
HIKMA PHARMS |
Labeling |
Approval |
| 07/01/2020 |
ATORVASTATIN CALCIUM
ANDA #205519 |
SUPPL-21 |
ATORVASTATIN CALCIUM |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 07/01/2020 |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #213046 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
TARO |
|
Approval |
| 07/01/2020 |
DOXEPIN HYDROCHLORIDE
ANDA #213063 |
ORIG-1 |
DOXEPIN HYDROCHLORIDE |
TARO |
|
Approval |
| 07/01/2020 |
PHENYLEPHRINE HYDROCHLORIDE
ANDA #213237 |
ORIG-1 |
PHENYLEPHRINE HYDROCHLORIDE |
ACCORD HLTHCARE |
|
Approval |
| 07/01/2020 |
LEVORPHANOL TARTRATE
ANDA #213479 |
ORIG-1 |
LEVORPHANOL TARTRATE |
NOVITIUM PHARMA |
|
Approval |
| 07/01/2020 |
TRIAMCINOLONE ACETONIDE
ANDA #213559 |
ORIG-1 |
TRIAMCINOLONE ACETONIDE |
QUAGEN |
|
Approval |
| 07/01/2020 |
FUROSEMIDE
ANDA #213902 |
ORIG-1 |
FUROSEMIDE |
GLAND PHARMA LTD |
|
Approval |
| 07/02/2020 |
HEPARIN SODIUM
NDA #017029 |
SUPPL-156 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
| 07/02/2020 |
HEPARIN SODIUM IN PLASTIC CONTAINER
NDA #017029 |
SUPPL-156 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
| 07/02/2020 |
HEPARIN SODIUM PRESERVATIVE FREE
NDA #017029 |
SUPPL-156 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
| 07/02/2020 |
HEPARIN SODIUM
NDA #017651 |
SUPPL-66 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
| 07/02/2020 |
OMNIPAQUE 12
NDA #018956 |
SUPPL-105 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 07/02/2020 |
OMNIPAQUE 140
NDA #018956 |
SUPPL-105 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 07/02/2020 |
OMNIPAQUE 180
NDA #018956 |
SUPPL-105 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 07/02/2020 |
OMNIPAQUE 210
NDA #018956 |
SUPPL-105 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 07/02/2020 |
OMNIPAQUE 240
NDA #018956 |
SUPPL-105 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 07/02/2020 |
OMNIPAQUE 300
NDA #018956 |
SUPPL-105 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 07/02/2020 |
OMNIPAQUE 350
NDA #018956 |
SUPPL-105 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 07/02/2020 |
OMNIPAQUE 70
NDA #018956 |
SUPPL-105 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 07/02/2020 |
OMNIPAQUE 9
NDA #018956 |
SUPPL-105 |
IOHEXOL |
GE HEALTHCARE |
Labeling |
Approval |
| 07/02/2020 |
VISIPAQUE 270
NDA #020351 |
SUPPL-50 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
| 07/02/2020 |
VISIPAQUE 320
NDA #020351 |
SUPPL-50 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
| 07/02/2020 |
SUMAVEL DOSEPRO
NDA #022239 |
SUPPL-7 |
SUMATRIPTAN SUCCINATE |
ENDO VENTURES LTD |
Labeling |
Approval |
| 07/02/2020 |
METHOCARBAMOL
ANDA #040489 |
SUPPL-15 |
METHOCARBAMOL |
OXFORD PHARMS |
Labeling |
Approval |
| 07/02/2020 |
OLOPATADINE HYDROCHLORIDE
ANDA #078350 |
SUPPL-7 |
OLOPATADINE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 07/02/2020 |
OFLOXACIN
ANDA #078559 |
SUPPL-12 |
OFLOXACIN |
FDC LTD |
Labeling |
Approval |
| 07/02/2020 |
METHOCARBAMOL
ANDA #203550 |
SUPPL-1 |
METHOCARBAMOL |
DBL PHARMS |
Labeling |
Approval |
| 07/02/2020 |
METHOCARBAMOL
ANDA #203550 |
SUPPL-2 |
METHOCARBAMOL |
DBL PHARMS |
Labeling |
Approval |
| 07/02/2020 |
ZOLPIDEM TARTRATE
ANDA #204229 |
SUPPL-1 |
ZOLPIDEM TARTRATE |
PAR PHARM INC |
Labeling |
Approval |
| 07/02/2020 |
ZOLPIDEM TARTRATE
ANDA #204229 |
SUPPL-2 |
ZOLPIDEM TARTRATE |
PAR PHARM INC |
Labeling |
Approval |
| 07/02/2020 |
FINGOLIMOD HYDROCHLORIDE
ANDA #208008 |
ORIG-1 |
FINGOLIMOD HYDROCHLORIDE |
TEVA PHARMS USA |
|
Approval |
| 07/02/2020 |
MULTRYS
NDA #209376 |
ORIG-1 |
CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE |
AM REGENT |
Type 4 - New Combination |
Approval |
| 07/02/2020 |
TRALEMENT
NDA #209376 |
ORIG-1 |
CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE |
AM REGENT |
Type 4 - New Combination |
Approval |
| 07/02/2020 |
APIXABAN
ANDA #210142 |
ORIG-1 |
APIXABAN |
TEVA PHARMS USA INC |
|
Tentative Approval |
| 07/02/2020 |
DEFERASIROX
ANDA #210555 |
ORIG-2 |
DEFERASIROX |
ALKEM LABS LTD |
|
Approval |
| 07/02/2020 |
ERLOTINIB HYDROCHLORIDE
ANDA #211083 |
ORIG-1 |
ERLOTINIB HYDROCHLORIDE |
ACCORD HLTHCARE |
|
Approval |
| 07/02/2020 |
BYFAVO
NDA #212295 |
ORIG-1 |
REMIMAZOLAM BESYLATE |
ACACIA |
Type 1 - New Molecular Entity |
Approval |
| 07/02/2020 |
RUKOBIA
NDA #212950 |
ORIG-1 |
FOSTEMSAVIR TROMETHAMINE |
VIIV HLTHCARE |
Type 1 - New Molecular Entity |
Approval |
| 07/06/2020 |
NORTREL 7/7/7
ANDA #075478 |
SUPPL-18 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 07/06/2020 |
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #075502 |
SUPPL-18 |
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE |
FOUGERA PHARMS |
Labeling |
Approval |
| 07/06/2020 |
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #075502 |
SUPPL-19 |
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE |
FOUGERA PHARMS |
Labeling |
Approval |
| 07/06/2020 |
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #075673 |
SUPPL-15 |
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE |
TARO |
Labeling |
Approval |
| 07/06/2020 |
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #075673 |
SUPPL-18 |
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE |
TARO |
Labeling |
Approval |
| 07/06/2020 |
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #075673 |
SUPPL-21 |
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE |
TARO |
Labeling |
Approval |
| 07/06/2020 |
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #076002 |
SUPPL-21 |
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE |
ACTAVIS MID ATLANTIC |
Labeling |
Approval |
| 07/06/2020 |
BENAZEPRIL HYDROCHLORIDE
ANDA #076118 |
SUPPL-24 |
BENAZEPRIL HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
| 07/06/2020 |
CYCLAFEM 7/7/7
ANDA #076338 |
SUPPL-10 |
ETHINYL ESTRADIOL; NORETHINDRONE |
VINTAGE PHARMS LLC |
Labeling |
Approval |
| 07/06/2020 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #076486 |
SUPPL-16 |
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE |
NOSTRUM LABS INC |
Labeling |
Approval |
| 07/06/2020 |
ARANELLE
ANDA #076783 |
SUPPL-11 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 07/06/2020 |
DIVALPROEX SODIUM
ANDA #078919 |
SUPPL-24 |
DIVALPROEX SODIUM |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 07/06/2020 |
DIVALPROEX SODIUM
ANDA #078919 |
SUPPL-25 |
DIVALPROEX SODIUM |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 07/06/2020 |
DIVALPROEX SODIUM
ANDA #078979 |
SUPPL-23 |
DIVALPROEX SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 07/06/2020 |
DASETTA 7/7/7
ANDA #090946 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORETHINDRONE |
NOVAST LABS LTD |
Labeling |
Approval |
| 07/06/2020 |
ALYACEN 1/35
ANDA #091634 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORETHINDRONE |
GLENMARK GENERICS |
Labeling |
Approval |
| 07/06/2020 |
ALYACEN 1/35
ANDA #091634 |
SUPPL-6 |
ETHINYL ESTRADIOL; NORETHINDRONE |
GLENMARK GENERICS |
Labeling |
Approval |
| 07/06/2020 |
ALYACEN 7/7/7
ANDA #091636 |
SUPPL-4 |
ETHINYL ESTRADIOL; NORETHINDRONE |
GLENMARK GENERICS |
Labeling |
Approval |
| 07/06/2020 |
ALYACEN 7/7/7
ANDA #091636 |
SUPPL-5 |
ETHINYL ESTRADIOL; NORETHINDRONE |
GLENMARK GENERICS |
Labeling |
Approval |
| 07/06/2020 |
ALYACEN 777
ANDA #091636 |
SUPPL-4 |
NORETHINDRONE; ETHINYL ESTRADIOL |
GLENMARK GENERICS |
Labeling |
Approval |
| 07/06/2020 |
ALYACEN 777
ANDA #091636 |
SUPPL-5 |
NORETHINDRONE; ETHINYL ESTRADIOL |
GLENMARK GENERICS |
Labeling |
Approval |
| 07/06/2020 |
CYRAMZA
BLA #125477 |
SUPPL-37 |
RAMUCIRUMAB |
ELI LILLY AND CO |
|
Approval |
| 07/06/2020 |
RIFAMPIN
ANDA #206736 |
SUPPL-1 |
RIFAMPIN |
WATSON PHARMS TEVA |
Labeling |
Approval |
| 07/06/2020 |
RIFAMPIN
ANDA #206736 |
SUPPL-2 |
RIFAMPIN |
WATSON PHARMS TEVA |
Labeling |
Approval |
| 07/06/2020 |
RIFAMPIN
ANDA #206736 |
SUPPL-3 |
RIFAMPIN |
WATSON PHARMS TEVA |
Labeling |
Approval |
| 07/06/2020 |
DALFAMPRIDINE
ANDA #206858 |
ORIG-1 |
DALFAMPRIDINE |
RISING |
|
Approval |
| 07/06/2020 |
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
ANDA #207825 |
ORIG-1 |
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE |
MYLAN PHARMS INC |
|
Approval |
| 07/06/2020 |
KISQALI
NDA #209092 |
SUPPL-5 |
RIBOCICLIB SUCCINATE |
NOVARTIS |
Efficacy |
Approval |
| 07/06/2020 |
KISQALI FEMARA CO-PACK (COPACKAGED)
NDA #209935 |
SUPPL-8 |
LETROZOLE; RIBOCICLIB SUCCINATE |
NOVARTIS |
Efficacy |
Approval |
| 07/06/2020 |
ERYTHROMYCIN
ANDA #212015 |
ORIG-1 |
ERYTHROMYCIN |
TORRENT |
|
Approval |
| 07/06/2020 |
VERAPAMIL HYDROCHLORIDE
ANDA #212965 |
ORIG-1 |
VERAPAMIL HYDROCHLORIDE |
EUGIA PHARMA |
|
Approval |
| 07/06/2020 |
CYCLOBENZAPRINE HYDROCHLORIDE
ANDA #213324 |
ORIG-1 |
CYCLOBENZAPRINE HYDROCHLORIDE |
UNICHEM |
|
Approval |
| 07/06/2020 |
LEVETIRACETAM IN SODIUM CHLORIDE
ANDA #213532 |
ORIG-1 |
LEVETIRACETAM |
NEXUS |
|
Approval |
| 07/06/2020 |
QWO
BLA #761146 |
ORIG-1 |
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM-AAES |
ENDO GLOBAL AESTHETICS LTD |
|
Approval |
| 07/06/2020 |
HULIO
BLA #761154 |
ORIG-1 |
ADALIMUMAB-FKJP |
MYLAN PHARMS INC |
|
Approval |
| 07/07/2020 |
CERVIDIL
NDA #020411 |
SUPPL-31 |
DINOPROSTONE |
FERRING PHARMS INC |
Labeling |
Approval |
| 07/07/2020 |
VIBATIV
NDA #022110 |
SUPPL-16 |
TELAVANCIN HYDROCHLORIDE |
CUMBERLAND PHARMS |
Labeling |
Approval |
| 07/07/2020 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075869 |
SUPPL-17 |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TEVA |
Labeling |
Approval |
| 07/07/2020 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075869 |
SUPPL-18 |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
TEVA |
Labeling |
Approval |
| 07/07/2020 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076194 |
SUPPL-35 |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
WATSON LABS |
Labeling |
Approval |
| 07/07/2020 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076194 |
SUPPL-37 |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
WATSON LABS |
Labeling |
Approval |
| 07/07/2020 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076194 |
SUPPL-38 |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
WATSON LABS |
Labeling |
Approval |
| 07/07/2020 |
BETAMETHASONE DIPROPIONATE
ANDA #076215 |
SUPPL-10 |
BETAMETHASONE DIPROPIONATE |
FOUGERA PHARMS |
Labeling |
Approval |
| 07/07/2020 |
BETAMETHASONE DIPROPIONATE
ANDA #076215 |
SUPPL-11 |
BETAMETHASONE DIPROPIONATE |
FOUGERA PHARMS |
Labeling |
Approval |
| 07/07/2020 |
BETAMETHASONE DIPROPIONATE
ANDA #076543 |
SUPPL-12 |
BETAMETHASONE DIPROPIONATE |
TARO |
Labeling |
Approval |
| 07/07/2020 |
BETAMETHASONE DIPROPIONATE
ANDA #078930 |
SUPPL-7 |
BETAMETHASONE DIPROPIONATE |
GLENMARK GENERICS |
Labeling |
Approval |
| 07/07/2020 |
BETAMETHASONE DIPROPIONATE
ANDA #078930 |
SUPPL-8 |
BETAMETHASONE DIPROPIONATE |
GLENMARK GENERICS |
Labeling |
Approval |
| 07/07/2020 |
PRASUGREL
ANDA #205926 |
ORIG-1 |
PRASUGREL HYDROCHLORIDE |
DR REDDYS |
|
Approval |
| 07/07/2020 |
EXONDYS 51
NDA #206488 |
SUPPL-19 |
ETEPLIRSEN |
SAREPTA THERAPS INC |
Labeling |
Approval |
| 07/07/2020 |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #211421 |
ORIG-1 |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
NUVO PHARMS INC |
|
Approval |
| 07/07/2020 |
CHLORPROMAZINE HYDROCHLORIDE
ANDA #211816 |
ORIG-1 |
CHLORPROMAZINE HYDROCHLORIDE |
EUGIA PHARMA |
|
Approval |
| 07/07/2020 |
EMPAGLIFLOZIN AND LINAGLIPTIN
ANDA #212359 |
ORIG-1 |
EMPAGLIFLOZIN; LINAGLIPTIN |
MSN LABS PVT LTD |
|
Tentative Approval |
| 07/07/2020 |
INQOVI
NDA #212576 |
ORIG-1 |
CEDAZURIDINE; DECITABINE |
OTSUKA |
Type 1 - New Molecular Entity and Type 4 - New Combination |
Approval |
| 07/08/2020 |
ETOMIDATE
ANDA #078289 |
SUPPL-7 |
ETOMIDATE |
RISING |
Labeling |
Approval |
| 07/08/2020 |
IMATINIB MESYLATE
ANDA #079179 |
SUPPL-3 |
IMATINIB MESYLATE |
APOTEX |
Labeling |
Approval |
| 07/08/2020 |
IMATINIB MESYLATE
ANDA #079179 |
SUPPL-4 |
IMATINIB MESYLATE |
APOTEX |
Labeling |
Approval |
| 07/08/2020 |
IMATINIB MESYLATE
ANDA #079179 |
SUPPL-6 |
IMATINIB MESYLATE |
APOTEX |
Labeling |
Approval |
| 07/08/2020 |
IMATINIB MESYLATE
ANDA #079179 |
SUPPL-8 |
IMATINIB MESYLATE |
APOTEX |
Labeling |
Approval |
| 07/08/2020 |
IMATINIB MESYLATE
ANDA #079179 |
SUPPL-10 |
IMATINIB MESYLATE |
APOTEX |
Labeling |
Approval |
| 07/08/2020 |
LEVETIRACETAM
ANDA #090187 |
SUPPL-3 |
LEVETIRACETAM |
APOTEX INC |
Labeling |
Approval |
| 07/08/2020 |
LEVETIRACETAM
ANDA #090187 |
SUPPL-4 |
LEVETIRACETAM |
APOTEX INC |
Labeling |
Approval |
| 07/08/2020 |
LEVETIRACETAM
ANDA #090187 |
SUPPL-5 |
LEVETIRACETAM |
APOTEX INC |
Labeling |
Approval |
| 07/08/2020 |
LEVETIRACETAM
ANDA #090187 |
SUPPL-6 |
LEVETIRACETAM |
APOTEX INC |
Labeling |
Approval |
| 07/08/2020 |
HEPARIN SODIUM
ANDA #090808 |
SUPPL-25 |
HEPARIN SODIUM |
SAGENT PHARMS |
Labeling |
Approval |
| 07/08/2020 |
BOTOX
BLA #103000 |
SUPPL-5315 |
OnabotulinumtoxinA |
ALLERGAN |
|
Approval |
| 07/08/2020 |
BOTOX COSMETIC
BLA #103000 |
SUPPL-5315 |
OnabotulinumtoxinA |
ALLERGAN |
|
Approval |
| 07/08/2020 |
DYSPORT
BLA #125274 |
SUPPL-118 |
abobotulinumtoxinA |
IPSEN BIOPHARM LTD |
|
Approval |
| 07/08/2020 |
LEVETIRACETAM
ANDA #201157 |
SUPPL-1 |
LEVETIRACETAM |
PHARM ASSOC |
Labeling |
Approval |
| 07/08/2020 |
LEVETIRACETAM
ANDA #201157 |
SUPPL-4 |
LEVETIRACETAM |
PHARM ASSOC |
Labeling |
Approval |
| 07/08/2020 |
LEVETIRACETAM
ANDA #201157 |
SUPPL-5 |
LEVETIRACETAM |
PHARM ASSOC |
Labeling |
Approval |
| 07/08/2020 |
LEVETIRACETAM
ANDA #201157 |
SUPPL-6 |
LEVETIRACETAM |
PHARM ASSOC |
Labeling |
Approval |
| 07/08/2020 |
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ANDA #204649 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
STRIDES PHARMA |
|
Approval |
| 07/08/2020 |
METHOCARBAMOL
ANDA #207522 |
SUPPL-1 |
METHOCARBAMOL |
SOMERSET THERAPS LLC |
Labeling |
Approval |
| 07/08/2020 |
METHOCARBAMOL
ANDA #207522 |
SUPPL-2 |
METHOCARBAMOL |
SOMERSET THERAPS LLC |
Labeling |
Approval |
| 07/08/2020 |
DOXYCYCLINE
ANDA #207757 |
SUPPL-1 |
DOXYCYCLINE HYCLATE |
ZYDUS PHARMS |
Labeling |
Approval |
| 07/08/2020 |
OLUMIANT
NDA #207924 |
SUPPL-2 |
BARICITINIB |
ELI LILLY AND CO |
Labeling |
Approval |
| 07/08/2020 |
DIAZOXIDE
ANDA #210799 |
ORIG-1 |
DIAZOXIDE |
NOVITIUM PHARMA |
|
Approval |
| 07/08/2020 |
UPNEEQ
NDA #212520 |
ORIG-1 |
OXYMETAZOLINE HYDROCHLORIDE |
RVL PHARMS |
|
Approval |
| 07/08/2020 |
GLYCOPYRROLATE
ANDA #213238 |
ORIG-1 |
GLYCOPYRROLATE |
ACCORD HLTHCARE |
|
Approval |
| 07/09/2020 |
NEXAVAR
NDA #021923 |
SUPPL-24 |
SORAFENIB TOSYLATE |
BAYER HLTHCARE |
Labeling |
Approval |
| 07/09/2020 |
PREGABALIN
ANDA #091025 |
ORIG-1 |
PREGABALIN |
ACTAVIS ELIZABETH |
|
Approval |
| 07/09/2020 |
SIGNIFOR LAR KIT
NDA #203255 |
SUPPL-8 |
PASIREOTIDE PAMOATE |
RECORDATI RARE |
Labeling |
Approval |
| 07/09/2020 |
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
ANDA #206532 |
ORIG-1 |
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE |
LUOXIN AUROVITAS |
|
Approval |
| 07/09/2020 |
IVERMECTIN
ANDA #210019 |
SUPPL-1 |
IVERMECTIN |
TEVA PHARMS USA |
Manufacturing (CMC) |
Approval |
| 07/09/2020 |
BACLOFEN
ANDA #212067 |
ORIG-1 |
BACLOFEN |
UNICHEM |
|
Approval |
| 07/09/2020 |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ANDA #212678 |
ORIG-1 |
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE |
EDENBRIDGE PHARMS |
|
Approval |
| 07/09/2020 |
FLUPHENAZINE HYDROCHLORIDE
ANDA #213647 |
ORIG-1 |
FLUPHENAZINE HYDROCHLORIDE |
AMNEAL |
|
Approval |
| 07/10/2020 |
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699 |
SUPPL-33 |
DEXTROSE; POTASSIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 07/10/2020 |
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699 |
SUPPL-33 |
DEXTROSE; POTASSIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 07/10/2020 |
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699 |
SUPPL-33 |
DEXTROSE; POTASSIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 07/10/2020 |
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699 |
SUPPL-33 |
DEXTROSE; POTASSIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 07/10/2020 |
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699 |
SUPPL-33 |
DEXTROSE; POTASSIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 07/10/2020 |
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019699 |
SUPPL-33 |
DEXTROSE; POTASSIUM CHLORIDE |
B BRAUN |
Labeling |
Approval |
| 07/10/2020 |
SUTENT
NDA #021938 |
SUPPL-38 |
SUNITINIB MALATE |
CPPI CV |
Labeling |
Approval |
| 07/10/2020 |
BUPROPION HYDROCHLORIDE
ANDA #090693 |
SUPPL-4 |
BUPROPION HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
| 07/10/2020 |
BUPROPION HYDROCHLORIDE
ANDA #090693 |
SUPPL-10 |
BUPROPION HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
| 07/10/2020 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091263 |
SUPPL-6 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
PADAGIS US |
Labeling |
Approval |
| 07/10/2020 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091263 |
SUPPL-7 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
PADAGIS US |
Labeling |
Approval |
| 07/10/2020 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091263 |
SUPPL-8 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
PADAGIS US |
Labeling |
Approval |
| 07/10/2020 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091263 |
SUPPL-9 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
PADAGIS US |
Labeling |
Approval |
| 07/10/2020 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091263 |
SUPPL-10 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
PADAGIS US |
Labeling |
Approval |
| 07/10/2020 |
LEVOCETIRIZINE DIHYDROCHLORIDE
ANDA #091263 |
SUPPL-11 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
PADAGIS US |
Labeling |
Approval |
| 07/10/2020 |
ICLUSIG
NDA #203469 |
SUPPL-33 |
PONATINIB HYDROCHLORIDE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 07/10/2020 |
VALSARTAN
ANDA #204821 |
SUPPL-3 |
VALSARTAN |
PRINSTON INC |
Labeling |
Approval |
| 07/10/2020 |
VALSARTAN
ANDA #204821 |
SUPPL-6 |
VALSARTAN |
PRINSTON INC |
Labeling |
Approval |
| 07/10/2020 |
EMFLAZA
NDA #208684 |
SUPPL-4 |
DEFLAZACORT |
PTC THERAP |
Labeling |
Approval |
| 07/10/2020 |
EMFLAZA
NDA #208685 |
SUPPL-4 |
DEFLAZACORT |
PTC THERAP |
Labeling |
Approval |
| 07/10/2020 |
ERLEADA
NDA #210951 |
SUPPL-2 |
APALUTAMIDE |
JANSSEN BIOTECH |
Labeling |
Approval |
| 07/10/2020 |
RINVOQ
NDA #211675 |
SUPPL-1 |
UPADACITINIB |
ABBVIE |
Labeling |
Approval |
| 07/10/2020 |
ACYCLOVIR
ANDA #212252 |
ORIG-1 |
ACYCLOVIR |
NOVITIUM PHARMA |
|
Approval |
| 07/10/2020 |
MAGNESIUM SULFATE IN PLASTIC CONTAINER
ANDA #213917 |
ORIG-1 |
MAGNESIUM SULFATE |
GLAND PHARMA LTD |
|
Approval |
| 07/11/2020 |
LEVETIRACETAM IN SODIUM CHLORIDE
ANDA #207160 |
SUPPL-2 |
LEVETIRACETAM |
EUGIA PHARMA |
Labeling |
Approval |
| 07/11/2020 |
LEVETIRACETAM IN SODIUM CHLORIDE
ANDA #207160 |
SUPPL-3 |
LEVETIRACETAM |
EUGIA PHARMA |
Labeling |
Approval |
| 07/11/2020 |
LEVETIRACETAM IN SODIUM CHLORIDE
ANDA #207160 |
SUPPL-4 |
LEVETIRACETAM |
EUGIA PHARMA |
Labeling |
Approval |
| 07/13/2020 |
IBUPROFEN
ANDA #075139 |
SUPPL-10 |
IBUPROFEN |
LNK |
Labeling |
Approval |
| 07/13/2020 |
RISPERIDONE
ANDA #078452 |
SUPPL-6 |
RISPERIDONE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 07/13/2020 |
RISPERIDONE
ANDA #078452 |
SUPPL-7 |
RISPERIDONE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 07/13/2020 |
RISPERIDONE
ANDA #078452 |
SUPPL-8 |
RISPERIDONE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 07/13/2020 |
RISPERIDONE
ANDA #078452 |
SUPPL-9 |
RISPERIDONE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 07/13/2020 |
RISPERIDONE
ANDA #078452 |
SUPPL-11 |
RISPERIDONE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 07/13/2020 |
MYALEPT
BLA #125390 |
SUPPL-21 |
METRELEPTIN |
AMRYT |
|
Approval |
| 07/13/2020 |
TOBI PODHALER
NDA #201688 |
SUPPL-10 |
TOBRAMYCIN |
MYLAN SPECIALITY LP |
Labeling |
Approval |
| 07/13/2020 |
LITHIUM CARBONATE
ANDA #202288 |
SUPPL-6 |
LITHIUM CARBONATE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 07/13/2020 |
LITHIUM CARBONATE
ANDA #204445 |
SUPPL-8 |
LITHIUM CARBONATE |
ALEMBIC |
Labeling |
Approval |
| 07/13/2020 |
LITHIUM CARBONATE
ANDA #204779 |
SUPPL-6 |
LITHIUM CARBONATE |
UNIQUE |
Labeling |
Approval |
| 07/13/2020 |
PATADAY ONCE DAILY RELIEF
NDA #206276 |
SUPPL-5 |
OLOPATADINE HYDROCHLORIDE |
ALCON LABS INC |
Efficacy |
Approval |
| 07/13/2020 |
AZACITIDINE
NDA #208216 |
SUPPL-5 |
AZACITIDINE |
ACTAVIS LLC |
Labeling |
Approval |
| 07/13/2020 |
ELETRIPTAN HYDROBROMIDE
ANDA #209680 |
ORIG-1 |
ELETRIPTAN HYDROBROMIDE |
YUNG SHIN PHARM |
|
Approval |
| 07/13/2020 |
ICATIBANT ACETATE
ANDA #212446 |
ORIG-1 |
ICATIBANT ACETATE |
CIPLA |
|
Approval |
| 07/13/2020 |
TREMFYA
BLA #761061 |
SUPPL-7 |
GUSELKUMAB |
JANSSEN BIOTECH |
|
Approval |
| 07/14/2020 |
NUTRILIPID 10%
NDA #019531 |
SUPPL-10 |
SOYBEAN OIL |
B BRAUN |
Labeling |
Approval |
| 07/14/2020 |
NUTRILIPID 20%
NDA #019531 |
SUPPL-10 |
SOYBEAN OIL |
B BRAUN |
Labeling |
Approval |
| 07/14/2020 |
ISENTRESS
NDA #022145 |
SUPPL-42 |
RALTEGRAVIR POTASSIUM |
MSD SUB MERCK |
Efficacy |
Approval |
| 07/14/2020 |
ISENTRESS HD
NDA #022145 |
SUPPL-42 |
RALTEGRAVIR POTASSIUM |
MSD SUB MERCK |
Efficacy |
Approval |
| 07/14/2020 |
ISENTRESS
NDA #203045 |
SUPPL-16 |
RALTEGRAVIR POTASSIUM |
MSD SUB MERCK |
Efficacy |
Approval |
| 07/14/2020 |
GATTEX KIT
NDA #203441 |
SUPPL-19 |
TEDUGLUTIDE RECOMBINANT |
TAKEDA PHARMS USA |
REMS |
Approval |
| 07/14/2020 |
ISENTRESS
NDA #205786 |
SUPPL-8 |
RALTEGRAVIR POTASSIUM |
MSD SUB MERCK |
Efficacy |
Approval |
| 07/14/2020 |
EPCLUSA
NDA #208341 |
SUPPL-15 |
SOFOSBUVIR; VELPATASVIR |
GILEAD SCIENCES INC |
Efficacy |
Approval |
| 07/14/2020 |
METHOCARBAMOL
ANDA #209312 |
SUPPL-4 |
METHOCARBAMOL |
GRANULES |
Labeling |
Approval |
| 07/14/2020 |
METHOCARBAMOL
ANDA #209312 |
SUPPL-5 |
METHOCARBAMOL |
GRANULES |
Labeling |
Approval |
| 07/14/2020 |
JULUCA
NDA #210192 |
SUPPL-7 |
DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE |
VIIV HLTHCARE |
Efficacy |
Approval |
| 07/14/2020 |
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA #210647 |
ORIG-1 |
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
ALKEM LABS LTD |
|
Approval |
| 07/14/2020 |
NYSTATIN AND TRIAMCINOLONE ACETONIDE
ANDA #213142 |
ORIG-1 |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
TORRENT |
|
Approval |
| 07/14/2020 |
DEFERASIROX
ANDA #213374 |
ORIG-1 |
DEFERASIROX |
ALKEM LABS LTD |
|
Approval |
| 07/14/2020 |
AMPHETAMINE SULFATE
ANDA #213898 |
ORIG-1 |
AMPHETAMINE SULFATE |
DR REDDYS LABS SA |
|
Approval |
| 07/14/2020 |
BETAMETHASONE DIPROPIONATE
ANDA #214048 |
ORIG-1 |
BETAMETHASONE DIPROPIONATE |
CADILA |
|
Approval |
| 07/15/2020 |
SEPTRA
NDA #017376 |
SUPPL-65 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
MONARCH PHARMS |
Labeling |
Approval |
| 07/15/2020 |
SEPTRA DS
NDA #017376 |
SUPPL-65 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
MONARCH PHARMS |
Labeling |
Approval |
| 07/15/2020 |
ENTOCORT EC
NDA #021324 |
SUPPL-23 |
BUDESONIDE |
PADAGIS US |
Labeling |
Approval |
| 07/15/2020 |
SYNTHROID
NDA #021402 |
SUPPL-34 |
LEVOTHYROXINE SODIUM |
ABBVIE |
Labeling |
Approval |
| 07/15/2020 |
OFLOXACIN
ANDA #076407 |
SUPPL-3 |
OFLOXACIN |
SENTISS |
Labeling |
Approval |
| 07/15/2020 |
OFLOXACIN
ANDA #076830 |
SUPPL-8 |
OFLOXACIN |
ALVOGEN |
Labeling |
Approval |
| 07/15/2020 |
AMIODARONE HYDROCHLORIDE
ANDA #077069 |
SUPPL-10 |
AMIODARONE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 07/15/2020 |
AMIODARONE HYDROCHLORIDE
ANDA #077069 |
SUPPL-11 |
AMIODARONE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 07/15/2020 |
AMIODARONE HYDROCHLORIDE
ANDA #077069 |
SUPPL-12 |
AMIODARONE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 07/15/2020 |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #088571 |
SUPPL-28 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 07/15/2020 |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #088571 |
SUPPL-30 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 07/15/2020 |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089635 |
SUPPL-33 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 07/15/2020 |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089635 |
SUPPL-35 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 07/15/2020 |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089644 |
SUPPL-31 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 07/15/2020 |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089644 |
SUPPL-34 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 07/15/2020 |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089645 |
SUPPL-30 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 07/15/2020 |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089645 |
SUPPL-32 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 07/15/2020 |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089646 |
SUPPL-31 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 07/15/2020 |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089646 |
SUPPL-35 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 07/15/2020 |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089651 |
SUPPL-30 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 07/15/2020 |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
ANDA #089651 |
SUPPL-32 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 07/15/2020 |
HEPARIN SODIUM
ANDA #090571 |
SUPPL-20 |
HEPARIN SODIUM |
HOSPIRA INC |
Labeling |
Approval |
| 07/15/2020 |
OLOPATADINE HYDROCHLORIDE
ANDA #204392 |
SUPPL-2 |
OLOPATADINE HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 07/15/2020 |
OLOPATADINE HYDROCHLORIDE
ANDA #204812 |
SUPPL-4 |
OLOPATADINE HYDROCHLORIDE |
EUGIA PHARMA |
Labeling |
Approval |
| 07/15/2020 |
COLESEVELAM HYDROCHLORIDE
ANDA #209946 |
ORIG-1 |
COLESEVELAM HYDROCHLORIDE |
ZHEJIANG JINGXIN |
|
Approval |
| 07/15/2020 |
OLOPATADINE HYDROCHLORIDE
ANDA #209995 |
SUPPL-1 |
OLOPATADINE HYDROCHLORIDE |
EUGIA PHARMA |
Labeling |
Approval |
| 07/15/2020 |
ZEMDRI
NDA #210303 |
SUPPL-5 |
PLAZOMICIN SULFATE |
CIPLA USA |
Labeling |
Approval |
| 07/15/2020 |
SILDENAFIL CITRATE
ANDA #211092 |
SUPPL-2 |
SILDENAFIL CITRATE |
AMNEAL PHARMS |
Labeling |
Approval |
| 07/15/2020 |
HEPARIN SODIUM
ANDA #212061 |
ORIG-1 |
HEPARIN SODIUM |
NANJING KING-FRIEND |
|
Approval |
| 07/16/2020 |
DIGOXIN
ANDA #040481 |
SUPPL-15 |
DIGOXIN |
SANDOZ |
Labeling |
Approval |
| 07/16/2020 |
DIGOXIN
ANDA #040481 |
SUPPL-16 |
DIGOXIN |
SANDOZ |
Labeling |
Approval |
| 07/16/2020 |
OXYCODONE AND ASPIRIN
ANDA #040910 |
ORIG-1 |
ASPIRIN; OXYCODONE HYDROCHLORIDE |
EPIC PHARMA LLC |
|
Approval |
| 07/16/2020 |
PROPOFOL
ANDA #074848 |
SUPPL-6 |
PROPOFOL |
HIKMA |
Labeling |
Approval |
| 07/16/2020 |
PROPOFOL
ANDA #074848 |
SUPPL-7 |
PROPOFOL |
HIKMA |
Labeling |
Approval |
| 07/16/2020 |
PROPOFOL
ANDA #074848 |
SUPPL-9 |
PROPOFOL |
HIKMA |
Labeling |
Approval |
| 07/16/2020 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #076674 |
SUPPL-19 |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
COREPHARMA |
Labeling |
Approval |
| 07/16/2020 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077606 |
SUPPL-22 |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
AUROBINDO |
Labeling |
Approval |
| 07/16/2020 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #077606 |
SUPPL-23 |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
AUROBINDO |
Labeling |
Approval |
| 07/16/2020 |
DOXORUBICIN HYDROCHLORIDE
ANDA #091495 |
SUPPL-5 |
DOXORUBICIN HYDROCHLORIDE |
SAGENT PHARMS |
Labeling |
Approval |
| 07/16/2020 |
SUMATRIPTAN SUCCINATE
ANDA #200263 |
SUPPL-2 |
SUMATRIPTAN SUCCINATE |
COREPHARMA |
Labeling |
Approval |
| 07/16/2020 |
TELMISARTAN
ANDA #205901 |
SUPPL-1 |
TELMISARTAN |
HETERO LABS LTD V |
Labeling |
Approval |
| 07/16/2020 |
TELMISARTAN
ANDA #205901 |
SUPPL-2 |
TELMISARTAN |
HETERO LABS LTD V |
Labeling |
Approval |
| 07/16/2020 |
TELMISARTAN
ANDA #205901 |
SUPPL-3 |
TELMISARTAN |
HETERO LABS LTD V |
Labeling |
Approval |
| 07/16/2020 |
CABOMETYX
NDA #208692 |
SUPPL-8 |
CABOZANTINIB S-MALATE |
EXELIXIS INC |
Labeling |
Approval |
| 07/16/2020 |
POTASSIUM CHLORIDE
ANDA #210041 |
SUPPL-3 |
POTASSIUM CHLORIDE |
AMNEAL |
Labeling |
Approval |
| 07/16/2020 |
TRANEXAMIC ACID
NDA #212020 |
SUPPL-3 |
TRANEXAMIC ACID |
EXELA PHARMA |
Labeling |
Approval |
| 07/16/2020 |
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #213585 |
ORIG-1 |
MILRINONE LACTATE |
GLAND PHARMA LTD |
|
Approval |
| 07/17/2020 |
VECTICAL
NDA #022087 |
SUPPL-9 |
CALCITRIOL |
GALDERMA LABS LP |
Efficacy |
Approval |
| 07/17/2020 |
QUTENZA
NDA #022395 |
SUPPL-19 |
CAPSAICIN |
AVERITAS |
Efficacy |
Approval |
| 07/17/2020 |
VOTRIENT
NDA #022465 |
SUPPL-30 |
PAZOPANIB HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
| 07/17/2020 |
DROSPIRENONE AND ETHINYL ESTRADIOL
ANDA #204296 |
SUPPL-1 |
DROSPIRENONE; ETHINYL ESTRADIOL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 07/17/2020 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #206953 |
ORIG-1 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
DR REDDYS LABS SA |
|
Approval |
| 07/17/2020 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
ANDA #209069 |
ORIG-1 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
WES PHARMA INC |
|
Approval |
| 07/17/2020 |
PHENYLEPHRINE HYDROCHLORIDE
ANDA #211081 |
ORIG-1 |
PHENYLEPHRINE HYDROCHLORIDE |
PROVEPHARM SAS |
|
Approval |
| 07/17/2020 |
REYVOW
NDA #211280 |
SUPPL-1 |
LASMIDITAN SUCCINATE |
ELI LILLY AND CO |
Labeling |
Approval |
| 07/17/2020 |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #211543 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
NESHER PHARMS |
|
Approval |
| 07/17/2020 |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
ANDA #212394 |
ORIG-1 |
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
ALEMBIC PHARMS LTD |
|
Tentative Approval |
| 07/17/2020 |
CLOPIDOGREL BISULFATE
ANDA #213351 |
ORIG-1 |
CLOPIDOGREL BISULFATE |
POLYGEN PHARMS |
|
Approval |
| 07/18/2020 |
GUANFACINE HYDROCHLORIDE
ANDA #202238 |
SUPPL-3 |
GUANFACINE HYDROCHLORIDE |
IMPAX LABS INC |
Labeling |
Approval |
| 07/18/2020 |
GUANFACINE HYDROCHLORIDE
ANDA #202238 |
SUPPL-4 |
GUANFACINE HYDROCHLORIDE |
IMPAX LABS INC |
Labeling |
Approval |
| 07/18/2020 |
GUANFACINE HYDROCHLORIDE
ANDA #202238 |
SUPPL-5 |
GUANFACINE HYDROCHLORIDE |
IMPAX LABS INC |
Labeling |
Approval |
| 07/18/2020 |
GUANFACINE HYDROCHLORIDE
ANDA #202578 |
SUPPL-2 |
GUANFACINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 07/18/2020 |
GUANFACINE HYDROCHLORIDE
ANDA #202578 |
SUPPL-3 |
GUANFACINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 07/18/2020 |
GUANFACINE HYDROCHLORIDE
ANDA #202578 |
SUPPL-5 |
GUANFACINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 07/18/2020 |
GUANFACINE HYDROCHLORIDE
ANDA #202578 |
SUPPL-6 |
GUANFACINE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 07/18/2020 |
TEMOZOLOMIDE
ANDA #204159 |
SUPPL-1 |
TEMOZOLOMIDE |
APOTEX |
Labeling |
Approval |
| 07/18/2020 |
TERIFLUNOMIDE
ANDA #209572 |
SUPPL-2 |
TERIFLUNOMIDE |
ALEMBIC |
Labeling |
Approval |
| 07/18/2020 |
TERIFLUNOMIDE
ANDA #209601 |
SUPPL-1 |
TERIFLUNOMIDE |
APOTEX |
Labeling |
Approval |
| 07/18/2020 |
TERIFLUNOMIDE
ANDA #209601 |
SUPPL-2 |
TERIFLUNOMIDE |
APOTEX |
Labeling |
Approval |
| 07/18/2020 |
CARBON DIOXIDE, USP
NDA #215007 |
ORIG-1 |
CARBON DIOIDE |
NEXAIR LLC |
|
Approval |
| 07/20/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #075658 |
SUPPL-30 |
FLUOXETINE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
| 07/20/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #075658 |
SUPPL-31 |
FLUOXETINE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
| 07/20/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #075658 |
SUPPL-32 |
FLUOXETINE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
| 07/20/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #075658 |
SUPPL-33 |
FLUOXETINE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
| 07/20/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #076444 |
SUPPL-11 |
HYDROMORPHONE HYDROCHLORIDE |
BARR |
Labeling |
Approval |
| 07/20/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #076444 |
SUPPL-12 |
HYDROMORPHONE HYDROCHLORIDE |
BARR |
Labeling |
Approval |
| 07/20/2020 |
OFLOXACIN
ANDA #076513 |
SUPPL-20 |
OFLOXACIN |
APOTEX INC |
Labeling |
Approval |
| 07/20/2020 |
SUMATRIPTAN SUCCINATE
ANDA #076554 |
SUPPL-8 |
SUMATRIPTAN SUCCINATE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 07/20/2020 |
SUMATRIPTAN SUCCINATE
ANDA #076572 |
SUPPL-8 |
SUMATRIPTAN SUCCINATE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 07/20/2020 |
SUMATRIPTAN SUCCINATE
ANDA #078284 |
SUPPL-7 |
SUMATRIPTAN SUCCINATE |
ORBION PHARMS |
Labeling |
Approval |
| 07/20/2020 |
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #078966 |
SUPPL-9 |
OMEPRAZOLE; SODIUM BICARBONATE |
STRIDES PHARMA |
Labeling |
Approval |
| 07/20/2020 |
SUMATRIPTAN SUCCINATE
ANDA #090314 |
SUPPL-6 |
SUMATRIPTAN SUCCINATE |
STERISCIENCE |
Labeling |
Approval |
| 07/20/2020 |
SUMATRIPTAN SUCCINATE
ANDA #090314 |
SUPPL-9 |
SUMATRIPTAN SUCCINATE |
STERISCIENCE |
Labeling |
Approval |
| 07/20/2020 |
SUMATRIPTAN SUCCINATE
ANDA #090641 |
SUPPL-6 |
SUMATRIPTAN SUCCINATE |
STERISCIENCE |
Labeling |
Approval |
| 07/20/2020 |
SUMATRIPTAN SUCCINATE
ANDA #090641 |
SUPPL-8 |
SUMATRIPTAN SUCCINATE |
STERISCIENCE |
Labeling |
Approval |
| 07/20/2020 |
DOCETAXEL
NDA #201195 |
SUPPL-15 |
DOCETAXEL |
ACCORD HLTHCARE |
Labeling |
Approval |
| 07/20/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #201336 |
SUPPL-1 |
FLUOXETINE HYDROCHLORIDE |
HERITAGE PHARMS |
Labeling |
Approval |
| 07/20/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #201336 |
SUPPL-2 |
FLUOXETINE HYDROCHLORIDE |
HERITAGE PHARMS |
Labeling |
Approval |
| 07/20/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #201336 |
SUPPL-3 |
FLUOXETINE HYDROCHLORIDE |
HERITAGE PHARMS |
Labeling |
Approval |
| 07/20/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #201336 |
SUPPL-4 |
FLUOXETINE HYDROCHLORIDE |
HERITAGE PHARMS |
Labeling |
Approval |
| 07/20/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #201336 |
SUPPL-5 |
FLUOXETINE HYDROCHLORIDE |
HERITAGE PHARMS |
Labeling |
Approval |
| 07/20/2020 |
PRASUGREL
ANDA #205888 |
SUPPL-3 |
PRASUGREL HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 07/20/2020 |
OXACILLIN SODIUM
ANDA #206198 |
ORIG-1 |
OXACILLIN SODIUM |
FRESENIUS KABI USA |
|
Approval |
| 07/20/2020 |
QBREXZA
NDA #210361 |
SUPPL-3 |
GLYCOPYRRONIUM TOSYLATE |
JOURNEY |
Manufacturing (CMC) |
Approval |
| 07/20/2020 |
WYNZORA
NDA #213422 |
ORIG-1 |
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE |
MC2 |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 07/20/2020 |
ROPIVACAINE HYDROCHLORIDE
ANDA #214074 |
ORIG-1 |
ROPIVACAINE HYDROCHLORIDE |
HIKMA |
|
Approval |
| 07/21/2020 |
XYREM
NDA #021196 |
SUPPL-33 |
SODIUM OXYBATE |
JAZZ PHARMS |
Labeling |
Approval |
| 07/21/2020 |
XYREM
NDA #021196 |
SUPPL-34 |
SODIUM OXYBATE |
JAZZ PHARMS |
REMS |
Approval |
| 07/21/2020 |
GABAPENTIN
ANDA #075350 |
SUPPL-60 |
GABAPENTIN |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 07/21/2020 |
GABAPENTIN
ANDA #075350 |
SUPPL-66 |
GABAPENTIN |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 07/21/2020 |
PAROXETINE HYDROCHLORIDE
ANDA #075356 |
SUPPL-37 |
PAROXETINE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
| 07/21/2020 |
SIMVASTATIN
ANDA #078034 |
SUPPL-13 |
SIMVASTATIN |
BIOCON PHARMA |
Labeling |
Approval |
| 07/21/2020 |
SIMVASTATIN
ANDA #078034 |
SUPPL-14 |
SIMVASTATIN |
BIOCON PHARMA |
Labeling |
Approval |
| 07/21/2020 |
SUMATRIPTAN SUCCINATE
ANDA #078067 |
SUPPL-2 |
SUMATRIPTAN SUCCINATE |
SANDOZ |
Labeling |
Approval |
| 07/21/2020 |
SUMATRIPTAN SUCCINATE
ANDA #078067 |
SUPPL-3 |
SUMATRIPTAN SUCCINATE |
SANDOZ |
Labeling |
Approval |
| 07/21/2020 |
LEVETIRACETAM
ANDA #203059 |
SUPPL-10 |
LEVETIRACETAM |
SUN PHARM |
Labeling |
Approval |
| 07/21/2020 |
LEVETIRACETAM
ANDA #203059 |
SUPPL-11 |
LEVETIRACETAM |
SUN PHARM |
Labeling |
Approval |
| 07/21/2020 |
NEVIRAPINE
ANDA #203080 |
SUPPL-2 |
NEVIRAPINE |
MICRO LABS LTD |
Labeling |
Approval |
| 07/21/2020 |
NEVIRAPINE
ANDA #203080 |
SUPPL-3 |
NEVIRAPINE |
MICRO LABS LTD |
Labeling |
Approval |
| 07/21/2020 |
STIVARGA
NDA #203085 |
SUPPL-13 |
REGORAFENIB |
BAYER HLTHCARE |
Labeling |
Approval |
| 07/21/2020 |
LANSOPRAZOLE
ANDA #203306 |
SUPPL-2 |
LANSOPRAZOLE |
NATCO |
Labeling |
Approval |
| 07/21/2020 |
LANSOPRAZOLE
ANDA #203306 |
SUPPL-3 |
LANSOPRAZOLE |
NATCO |
Labeling |
Approval |
| 07/21/2020 |
LANSOPRAZOLE
ANDA #203306 |
SUPPL-4 |
LANSOPRAZOLE |
NATCO |
Labeling |
Approval |
| 07/21/2020 |
BUPIVACAINE HYDROCHLORIDE
ANDA #207183 |
SUPPL-2 |
BUPIVACAINE HYDROCHLORIDE |
EUGIA PHARMA |
Labeling |
Approval |
| 07/21/2020 |
DOXORUBICIN HYDROCHLORIDE
ANDA #209825 |
SUPPL-3 |
DOXORUBICIN HYDROCHLORIDE |
GLAND PHARMA LTD |
Labeling |
Approval |
| 07/21/2020 |
DOXORUBICIN HYDROCHLORIDE
ANDA #209825 |
SUPPL-5 |
DOXORUBICIN HYDROCHLORIDE |
GLAND PHARMA LTD |
Labeling |
Approval |
| 07/21/2020 |
CHLORZOXAZONE
ANDA #211849 |
ORIG-1 |
CHLORZOXAZONE |
DR REDDYS LABS SA |
|
Approval |
| 07/21/2020 |
XYWAV
NDA #212690 |
ORIG-1 |
CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE |
JAZZ |
Type 2 - New Active Ingredient |
Approval |
| 07/21/2020 |
CEFEPIME HYDROCHLORIDE
ANDA #212721 |
ORIG-1 |
CEFEPIME HYDROCHLORIDE |
ASTRAL |
|
Approval |
| 07/21/2020 |
AMIODARONE HYDROCHLORIDE
ANDA #213446 |
ORIG-1 |
AMIODARONE HYDROCHLORIDE |
UNICHEM |
|
Approval |
| 07/22/2020 |
MONISTAT 7
NDA #017450 |
SUPPL-75 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Manufacturing (CMC) |
Approval |
| 07/22/2020 |
COPAXONE
NDA #020622 |
SUPPL-110 |
GLATIRAMER ACETATE |
TEVA PHARMS USA |
Labeling |
Approval |
| 07/22/2020 |
MONISTAT 3 COMBINATION PACK
NDA #020670 |
SUPPL-36 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Manufacturing (CMC) |
Approval |
| 07/22/2020 |
MONISTAT 3 COMBINATION PACK
NDA #021261 |
SUPPL-25 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Manufacturing (CMC) |
Approval |
| 07/22/2020 |
MONISTAT 3 COMBINATION PACK (PREFILLED)
NDA #021261 |
SUPPL-25 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Manufacturing (CMC) |
Approval |
| 07/22/2020 |
MONISTAT 1 COMBINATION PACK
NDA #021308 |
SUPPL-31 |
MICONAZOLE NITRATE |
MEDTECH PRODUCTS |
Manufacturing (CMC) |
Approval |
| 07/22/2020 |
DUTASTERIDE
ANDA #203118 |
SUPPL-2 |
DUTASTERIDE |
AMNEAL PHARMS |
Labeling |
Approval |
| 07/22/2020 |
PHENYLEPHRINE HYDROCHLORIDE
ANDA #208905 |
SUPPL-2 |
PHENYLEPHRINE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 07/22/2020 |
PHENYLEPHRINE HYDROCHLORIDE
ANDA #208905 |
SUPPL-3 |
PHENYLEPHRINE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 07/22/2020 |
APREMILAST
ANDA #211658 |
ORIG-1 |
APREMILAST |
SANDOZ INC |
|
Tentative Approval |
| 07/22/2020 |
EMPAGLIFLOZIN; LINAGLIPTIN
ANDA #212335 |
ORIG-1 |
EMPAGLIFLOZIN;LINAGLIPTIN |
LUPIN LTD |
|
Tentative Approval |
| 07/22/2020 |
MEXILETINE HYDROCHLORIDE
ANDA #213500 |
ORIG-1 |
MEXILETINE HYDROCHLORIDE |
CROSSMEDIKA SA |
|
Approval |
| 07/23/2020 |
EXJADE
NDA #021882 |
SUPPL-33 |
DEFERASIROX |
NOVARTIS |
Efficacy |
Approval |
| 07/23/2020 |
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #070705 |
SUPPL-22 |
HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE |
ANI PHARMS |
Labeling |
Approval |
| 07/23/2020 |
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #072043 |
SUPPL-16 |
HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE |
ANI PHARMS |
Labeling |
Approval |
| 07/23/2020 |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
ANDA #076608 |
SUPPL-5 |
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE |
ANI PHARMS |
Labeling |
Approval |
| 07/23/2020 |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
ANDA #077144 |
SUPPL-1 |
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE |
ANI PHARMS |
Labeling |
Approval |
| 07/23/2020 |
MONTELUKAST SODIUM
ANDA #078605 |
SUPPL-13 |
MONTELUKAST SODIUM |
TEVA PHARMS |
Labeling |
Approval |
| 07/23/2020 |
MONTELUKAST SODIUM
ANDA #078723 |
SUPPL-13 |
MONTELUKAST SODIUM |
TEVA PHARMS |
Labeling |
Approval |
| 07/23/2020 |
CISATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #200154 |
SUPPL-9 |
CISATRACURIUM BESYLATE |
SANDOZ INC |
Labeling |
Approval |
| 07/23/2020 |
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA #203345 |
SUPPL-1 |
OMEPRAZOLE; SODIUM BICARBONATE |
ZYDUS |
Labeling |
Approval |
| 07/23/2020 |
JADENU
NDA #206910 |
SUPPL-15 |
DEFERASIROX |
NOVARTIS PHARMS CORP |
Efficacy |
Approval |
| 07/23/2020 |
MONTELUKAST SODIUM
ANDA #207463 |
SUPPL-2 |
MONTELUKAST SODIUM |
CIPLA |
Labeling |
Approval |
| 07/23/2020 |
MONTELUKAST SODIUM
ANDA #207463 |
SUPPL-3 |
MONTELUKAST SODIUM |
CIPLA |
Labeling |
Approval |
| 07/23/2020 |
MONTELUKAST SODIUM
ANDA #207463 |
SUPPL-4 |
MONTELUKAST SODIUM |
CIPLA |
Labeling |
Approval |
| 07/23/2020 |
MONTELUKAST SODIUM
ANDA #207464 |
SUPPL-1 |
MONTELUKAST SODIUM |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 07/23/2020 |
MONTELUKAST SODIUM
ANDA #207464 |
SUPPL-2 |
MONTELUKAST SODIUM |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 07/23/2020 |
MONTELUKAST SODIUM
ANDA #207464 |
SUPPL-3 |
MONTELUKAST SODIUM |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 07/23/2020 |
JADENU SPRINKLE
NDA #207968 |
SUPPL-9 |
DEFERASIROX |
NOVARTIS |
Efficacy |
Approval |
| 07/23/2020 |
BREZTRI AEROSPHERE
NDA #212122 |
ORIG-1 |
BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE |
ASTRAZENECA AB |
|
Approval |
| 07/23/2020 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #212697 |
ORIG-1 |
METHYLPHENIDATE HYDROCHLORIDE |
PRINSTON INC |
|
Approval |
| 07/23/2020 |
IMATINIB MESYLATE
ANDA #212773 |
ORIG-1 |
IMATINIB MESYLATE |
EUGIA PHARMA |
|
Approval |
| 07/24/2020 |
LEVETIRACETAM
ANDA #077324 |
SUPPL-8 |
LEVETIRACETAM |
FOSUN PHARMA |
Manufacturing (CMC) |
Approval |
| 07/24/2020 |
RAMIPRIL
ANDA #078745 |
SUPPL-11 |
RAMIPRIL |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 07/24/2020 |
LEVETIRACETAM
ANDA #091485 |
SUPPL-3 |
LEVETIRACETAM |
BEOWULF ASSET |
Labeling |
Approval |
| 07/24/2020 |
LEVETIRACETAM
ANDA #091485 |
SUPPL-4 |
LEVETIRACETAM |
BEOWULF ASSET |
Labeling |
Approval |
| 07/24/2020 |
DOXEPIN HYDROCHLORIDE
ANDA #202510 |
ORIG-1 |
DOXEPIN HYDROCHLORIDE |
STRIDES PHARMA |
|
Approval |
| 07/24/2020 |
ACETAMINOPHEN
ANDA #204052 |
SUPPL-2 |
ACETAMINOPHEN |
SANDOZ |
Labeling |
Approval |
| 07/24/2020 |
XEGLYZE
NDA #206966 |
ORIG-1 |
ABAMETAPIR |
HATCHTECH |
Type 1 - New Molecular Entity |
Approval |
| 07/24/2020 |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #207310 |
SUPPL-10 |
SODIUM CHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 07/24/2020 |
ANASTROZOLE
ANDA #212434 |
ORIG-1 |
ANASTROZOLE |
EUGIA PHARMA |
|
Approval |
| 07/24/2020 |
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #212441 |
ORIG-1 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
|
Approval |
| 07/24/2020 |
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #212441 |
ORIG-1 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
|
Approval |
| 07/24/2020 |
DOXEPIN HYDROCHLORIDE
ANDA #212997 |
ORIG-1 |
DOXEPIN HYDROCHLORIDE |
LANNETT CO INC |
|
Approval |
| 07/24/2020 |
METYROSINE
ANDA #213734 |
ORIG-1 |
METYROSINE |
AMNEAL |
|
Approval |
| 07/26/2020 |
CLOZAPINE
ANDA #201824 |
SUPPL-11 |
CLOZAPINE |
MYLAN |
Labeling |
Approval |
| 07/27/2020 |
NAFCILLIN SODIUM
ANDA #062527 |
SUPPL-31 |
NAFCILLIN SODIUM |
SANDOZ |
Labeling |
Approval |
| 07/27/2020 |
CYCLOSPORINE
ANDA #065167 |
SUPPL-15 |
CYCLOSPORINE |
PHARM ASSOC |
Labeling |
Approval |
| 07/27/2020 |
DIAZEPAM INTENSOL
ANDA #071415 |
SUPPL-16 |
DIAZEPAM |
HIKMA |
Manufacturing (CMC) |
Approval |
| 07/27/2020 |
VINORELBINE TARTRATE
ANDA #078011 |
SUPPL-4 |
VINORELBINE TARTRATE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 07/27/2020 |
VINORELBINE TARTRATE
ANDA #078011 |
SUPPL-6 |
VINORELBINE TARTRATE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 07/27/2020 |
NAFCILLIN SODIUM
ANDA #090005 |
SUPPL-5 |
NAFCILLIN SODIUM |
ISTITUTO BIO ITA SPA |
Labeling |
Approval |
| 07/27/2020 |
NAFCILLIN SODIUM
ANDA #090005 |
SUPPL-6 |
NAFCILLIN SODIUM |
ISTITUTO BIO ITA SPA |
Labeling |
Approval |
| 07/27/2020 |
NAFCILLIN SODIUM
ANDA #090005 |
SUPPL-7 |
NAFCILLIN SODIUM |
ISTITUTO BIO ITA SPA |
Labeling |
Approval |
| 07/27/2020 |
VINORELBINE TARTRATE
ANDA #091106 |
SUPPL-5 |
VINORELBINE TARTRATE |
JIANGSU HANSOH PHARM |
Labeling |
Approval |
| 07/27/2020 |
VINORELBINE TARTRATE
ANDA #091106 |
SUPPL-7 |
VINORELBINE TARTRATE |
JIANGSU HANSOH PHARM |
Labeling |
Approval |
| 07/27/2020 |
DOCETAXEL
NDA #203551 |
SUPPL-9 |
DOCETAXEL |
ACTAVIS |
Labeling |
Approval |
| 07/27/2020 |
OXACILLIN SODIUM
ANDA #206199 |
ORIG-1 |
OXACILLIN SODIUM |
FRESENIUS KABI USA |
|
Approval |
| 07/27/2020 |
PHENYLEPHRINE HYDROCHLORIDE
ANDA #210025 |
SUPPL-3 |
PHENYLEPHRINE HYDROCHLORIDE |
PAR STERILE PRODUCTS |
Labeling |
Approval |
| 07/27/2020 |
PYRAZINAMIDE
ANDA #212541 |
ORIG-1 |
PYRAZINAMIDE |
MACLEODS PHARMS LTD |
|
Approval |
| 07/28/2020 |
ALDACTONE
NDA #012151 |
SUPPL-77 |
SPIRONOLACTONE |
PFIZER |
Labeling |
Approval |
| 07/28/2020 |
BACTRIM
NDA #017377 |
SUPPL-80 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 07/28/2020 |
BACTRIM DS
NDA #017377 |
SUPPL-80 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 07/28/2020 |
BACTRIM
NDA #017560 |
SUPPL-44 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 07/28/2020 |
BACTRIM PEDIATRIC
NDA #017560 |
SUPPL-44 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 07/28/2020 |
ARTHROTEC
NDA #020607 |
SUPPL-33 |
DICLOFENAC SODIUM; MISOPROSTOL |
PFIZER |
Labeling |
Approval |
| 07/28/2020 |
FASLODEX
NDA #021344 |
SUPPL-42 |
FULVESTRANT |
ASTRAZENECA |
Efficacy |
Approval |
| 07/28/2020 |
AMPICILLIN AND SULBACTAM
ANDA #065188 |
SUPPL-10 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
HQ SPECLT PHARMA |
Manufacturing (CMC) |
Approval |
| 07/28/2020 |
GABAPENTIN
ANDA #075360 |
SUPPL-19 |
GABAPENTIN |
GRANULES |
Labeling |
Approval |
| 07/28/2020 |
GABAPENTIN
ANDA #075360 |
SUPPL-22 |
GABAPENTIN |
GRANULES |
Labeling |
Approval |
| 07/28/2020 |
GABAPENTIN
ANDA #075360 |
SUPPL-23 |
GABAPENTIN |
GRANULES |
Labeling |
Approval |
| 07/28/2020 |
GABAPENTIN
ANDA #075360 |
SUPPL-25 |
GABAPENTIN |
GRANULES |
Labeling |
Approval |
| 07/28/2020 |
OFLOXACIN
ANDA #076622 |
SUPPL-11 |
OFLOXACIN |
BAUSCH AND LOMB |
Labeling |
Approval |
| 07/28/2020 |
NAPROXEN
ANDA #078250 |
SUPPL-14 |
NAPROXEN |
GLENMARK GENERICS |
Labeling |
Approval |
| 07/28/2020 |
NAPROXEN
ANDA #078250 |
SUPPL-16 |
NAPROXEN |
GLENMARK GENERICS |
Labeling |
Approval |
| 07/28/2020 |
NAPROXEN
ANDA #078250 |
SUPPL-18 |
NAPROXEN |
GLENMARK GENERICS |
Labeling |
Approval |
| 07/28/2020 |
NAPROXEN SODIUM
ANDA #078314 |
SUPPL-6 |
NAPROXEN SODIUM |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 07/28/2020 |
NAPROXEN SODIUM
ANDA #078314 |
SUPPL-8 |
NAPROXEN SODIUM |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 07/28/2020 |
NAPROXEN SODIUM
ANDA #078314 |
SUPPL-12 |
NAPROXEN SODIUM |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 07/28/2020 |
DEXAMETHASONE SODIUM PHOSPHATE
ANDA #084916 |
SUPPL-65 |
DEXAMETHASONE SODIUM PHOSPHATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 07/28/2020 |
DEXAMETHASONE SODIUM PHOSPHATE
ANDA #084916 |
SUPPL-69 |
DEXAMETHASONE SODIUM PHOSPHATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 07/28/2020 |
LEVETIRACETAM
ANDA #203052 |
SUPPL-1 |
LEVETIRACETAM |
HETERO LABS LTD III |
Labeling |
Approval |
| 07/28/2020 |
LEVETIRACETAM
ANDA #203052 |
SUPPL-2 |
LEVETIRACETAM |
HETERO LABS LTD III |
Labeling |
Approval |
| 07/28/2020 |
LEVETIRACETAM
ANDA #203052 |
SUPPL-4 |
LEVETIRACETAM |
HETERO LABS LTD III |
Labeling |
Approval |
| 07/28/2020 |
LEVETIRACETAM
ANDA #203052 |
SUPPL-9 |
LEVETIRACETAM |
HETERO LABS LTD III |
Labeling |
Approval |
| 07/28/2020 |
LEVETIRACETAM
ANDA #203052 |
SUPPL-10 |
LEVETIRACETAM |
HETERO LABS LTD III |
Labeling |
Approval |
| 07/28/2020 |
LEVETIRACETAM
ANDA #203052 |
SUPPL-12 |
LEVETIRACETAM |
HETERO LABS LTD III |
Labeling |
Approval |
| 07/28/2020 |
DEXAMETHASONE SODIUM PHOSPHATE
ANDA #203129 |
SUPPL-2 |
DEXAMETHASONE SODIUM PHOSPHATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 07/28/2020 |
DOCETAXEL
ANDA #203877 |
SUPPL-1 |
DOCETAXEL |
TEVA PHARMS USA |
Labeling |
Approval |
| 07/28/2020 |
DOCETAXEL
ANDA #203877 |
SUPPL-3 |
DOCETAXEL |
TEVA PHARMS USA |
Labeling |
Approval |
| 07/28/2020 |
APIXABAN
ANDA #210180 |
ORIG-1 |
APIXABAN |
ACCORD HLTHCARE |
|
Approval |
| 07/28/2020 |
DOXEPIN HYDROCHLORIDE
ANDA #213474 |
ORIG-1 |
DOXEPIN HYDROCHLORIDE |
CONTRACT PHARMACAL |
|
Approval |
| 07/29/2020 |
BACTRIM
NDA #018374 |
SUPPL-27 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
SUN PHARM INDS INC |
Labeling |
Approval |
| 07/29/2020 |
WELCHOL
NDA #021176 |
SUPPL-48 |
COLESEVELAM HYDROCHLORIDE |
COSETTE |
Labeling |
Approval |
| 07/29/2020 |
WELCHOL
NDA #022362 |
SUPPL-28 |
COLESEVELAM HYDROCHLORIDE |
COSETTE |
Labeling |
Approval |
| 07/29/2020 |
DEXAMETHASONE SODIUM PHOSPHATE
ANDA #084282 |
SUPPL-48 |
DEXAMETHASONE SODIUM PHOSPHATE |
WEST-WARD PHARMS INT |
Labeling |
Approval |
| 07/29/2020 |
HYDROCHLOROTHIAZIDE
ANDA #085182 |
SUPPL-37 |
HYDROCHLOROTHIAZIDE |
HERITAGE PHARMS |
Labeling |
Approval |
| 07/29/2020 |
DEXAMETHASONE SODIUM PHOSPHATE
ANDA #087702 |
SUPPL-39 |
DEXAMETHASONE SODIUM PHOSPHATE |
WEST-WARD PHARMS INT |
Labeling |
Approval |
| 07/29/2020 |
DEXAMETHASONE SODIUM PHOSPHATE
ANDA #087702 |
SUPPL-41 |
DEXAMETHASONE SODIUM PHOSPHATE |
WEST-WARD PHARMS INT |
Labeling |
Approval |
| 07/29/2020 |
STELARA
BLA #125261 |
SUPPL-150 |
USTEKINUMAB |
CENTOCOR ORTHO BIOTECH INC |
|
Approval |
| 07/29/2020 |
VERSACLOZ
NDA #203479 |
SUPPL-12 |
CLOZAPINE |
TASMAN PHARMA |
Labeling |
Approval |
| 07/29/2020 |
HEPARIN SODIUM
ANDA #203851 |
SUPPL-10 |
HEPARIN SODIUM |
MYLAN LABS LTD |
Labeling |
Approval |
| 07/29/2020 |
TOLCAPONE
ANDA #207729 |
ORIG-1 |
TOLCAPONE |
ALVOGEN |
|
Approval |
| 07/29/2020 |
NERLYNX
NDA #208051 |
SUPPL-7 |
NERATINIB MALEATE |
PUMA BIOTECH |
Efficacy |
Approval |
| 07/29/2020 |
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
ANDA #210579 |
ORIG-1 |
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE |
MISEMER |
|
Approval |
| 07/29/2020 |
CLINDAMYCIN PHOSPHATE
ANDA #211872 |
ORIG-1 |
CLINDAMYCIN PHOSPHATE |
SOLARIS PHARMA CORP |
|
Approval |
| 07/29/2020 |
METHYLPHENIDATE HYDROCHLORIDE
ANDA #213473 |
ORIG-1 |
METHYLPHENIDATE HYDROCHLORIDE |
DR REDDYS |
|
Approval |
| 07/30/2020 |
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916 |
SUPPL-71 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
| 07/30/2020 |
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916 |
SUPPL-71 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
| 07/30/2020 |
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916 |
SUPPL-71 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
| 07/30/2020 |
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916 |
SUPPL-71 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
| 07/30/2020 |
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916 |
SUPPL-71 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
| 07/30/2020 |
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916 |
SUPPL-71 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
| 07/30/2020 |
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #018916 |
SUPPL-71 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
| 07/30/2020 |
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018916 |
SUPPL-71 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
| 07/30/2020 |
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #018916 |
SUPPL-71 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
| 07/30/2020 |
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
NDA #018916 |
SUPPL-71 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
| 07/30/2020 |
DEFINITY
NDA #021064 |
SUPPL-23 |
PERFLUTREN |
LANTHEUS MEDCL |
Labeling |
Approval |
| 07/30/2020 |
DEFINITY RT
NDA #021064 |
SUPPL-23 |
PERFLUTREN |
LANTHEUS MEDCL |
Labeling |
Approval |
| 07/30/2020 |
ADVIL CONGESTION RELIEF
NDA #022565 |
SUPPL-6 |
IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 07/30/2020 |
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #074896 |
SUPPL-30 |
CAPTOPRIL; HYDROCHLOROTHIAZIDE |
RISING |
Labeling |
Approval |
| 07/30/2020 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE
ANDA #075926 |
SUPPL-15 |
HYDROCHLOROTHIAZIDE; LISINOPRIL |
EPIC PHARMA LLC |
Labeling |
Approval |
| 07/30/2020 |
GADAVIST
NDA #201277 |
SUPPL-18 |
GADOBUTROL |
BAYER HLTHCARE |
Labeling |
Approval |
| 07/30/2020 |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
ANDA #210502 |
ORIG-1 |
CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
DR REDDYS LABS LTD |
|
Tentative Approval |
| 07/30/2020 |
CARBIDOPA; LEODOPA
ANDA #210911 |
ORIG-1 |
CARBIDOPA;LEODOPA |
ZYDUS PHARMS USA INC |
|
Tentative Approval |
| 07/30/2020 |
LEUCOVORIN CALCIUM
ANDA #211132 |
ORIG-1 |
LEUCOVORIN CALCIUM |
NOVAST LABS |
|
Approval |
| 07/30/2020 |
TEGSEDI
NDA #211172 |
SUPPL-8 |
INOTERSEN SODIUM |
AKCEA THERAPS |
Labeling |
Approval |
| 07/30/2020 |
APREMILAST
ANDA #211887 |
ORIG-1 |
APREMILAST |
MSN PHARMACEUTICALS INC |
|
Tentative Approval |
| 07/30/2020 |
CYCLOPHOSPHAMIDE
NDA #212501 |
ORIG-1 |
CYCLOPHOSPHAMIDE |
INGENUS PHARMS LLC |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 07/30/2020 |
TECENTRIQ
BLA #761034 |
SUPPL-28 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
| 07/31/2020 |
MYCAMINE
NDA #021506 |
SUPPL-24 |
MICAFUNGIN SODIUM |
ASTELLAS |
Manufacturing (CMC) |
Tentative Approval |
| 07/31/2020 |
LARIN FE 1.5/30
ANDA #091453 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
NOVAST LABS |
Labeling |
Approval |
| 07/31/2020 |
ERIVEDGE
NDA #203388 |
SUPPL-16 |
VISMODEGIB |
GENENTECH |
Labeling |
Approval |
| 07/31/2020 |
CISATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #204960 |
SUPPL-8 |
CISATRACURIUM BESYLATE |
HENGRUI PHARMA |
Labeling |
Approval |
| 07/31/2020 |
IBANDRONATE SODIUM
ANDA #205332 |
SUPPL-4 |
IBANDRONATE SODIUM |
EUGIA PHARMA |
Manufacturing (CMC) |
Approval |
| 07/31/2020 |
PREZCOBIX
NDA #205395 |
SUPPL-16 |
COBICISTAT; DARUNAVIR |
JANSSEN PRODS |
Efficacy |
Approval |
| 07/31/2020 |
OLANZAPINE
ANDA #206155 |
ORIG-1 |
OLANZAPINE |
INDOCO |
|
Approval |
| 07/31/2020 |
EVOTAZ
NDA #206353 |
SUPPL-7 |
ATAZANAVIR SULFATE; COBICISTAT |
BRISTOL |
Efficacy |
Approval |
| 07/31/2020 |
CISATRACURIUM BESYLATE
ANDA #209334 |
SUPPL-4 |
CISATRACURIUM BESYLATE |
HENGRUI PHARMA |
Labeling |
Approval |
| 07/31/2020 |
MAYZENT
NDA #209884 |
SUPPL-2 |
SIPONIMOD |
NOVARTIS |
Labeling |
Approval |
| 07/31/2020 |
EPIDIOLEX
NDA #210365 |
SUPPL-5 |
CANNABIDIOL |
GW RES LTD |
Efficacy |
Approval |
| 07/31/2020 |
EPIDIOLEX
NDA #210365 |
SUPPL-6 |
CANNABIDIOL |
GW RES LTD |
Efficacy |
Approval |
| 07/31/2020 |
EPIDIOLEX
NDA #210365 |
SUPPL-7 |
CANNABIDIOL |
GW RES LTD |
Labeling |
Approval |
| 07/31/2020 |
TIGECYCLINE
NDA #211158 |
SUPPL-3 |
TIGECYCLINE |
AMNEAL |
Labeling |
Approval |
| 07/31/2020 |
SPRAVATO
NDA #211243 |
SUPPL-4 |
ESKETAMINE HYDROCHLORIDE |
JANSSEN PHARMS |
Efficacy |
Approval |
| 07/31/2020 |
MYCOPHENOLATE MOFETIL
ANDA #212087 |
ORIG-1 |
MYCOPHENOLATE MOFETIL |
CONCORD BIOTECH LTD |
|
Approval |
| 07/31/2020 |
NAPROXEN
ANDA #212705 |
ORIG-1 |
NAPROXEN |
AMNEAL |
|
Approval |
| 07/31/2020 |
MONJUVI
BLA #761163 |
ORIG-1 |
TAFASITAMAB-CXIX |
MORPHOSYS US INC |
|
Approval |
