| 05/01/2020 |
APOKYN
NDA #021264 |
SUPPL-18 |
APOMORPHINE HYDROCHLORIDE |
MDD US |
Labeling |
Approval |
| 05/01/2020 |
APLENZIN
NDA #022108 |
SUPPL-20 |
BUPROPION HYDROBROMIDE |
BAUSCH |
Labeling |
Approval |
| 05/01/2020 |
CEFEPIME IN PLASTIC CONTAINER
NDA #050817 |
SUPPL-8 |
CEFEPIME HYDROCHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 05/01/2020 |
DOXYCYCLINE
ANDA #062450 |
SUPPL-21 |
DOXYCYCLINE HYCLATE |
HIKMA |
Labeling |
Approval |
| 05/01/2020 |
DOXYCYCLINE
ANDA #062450 |
SUPPL-22 |
DOXYCYCLINE HYCLATE |
HIKMA |
Labeling |
Approval |
| 05/01/2020 |
AZITHROMYCIN
ANDA #065398 |
SUPPL-5 |
AZITHROMYCIN |
LUPIN LTD |
Labeling |
Approval |
| 05/01/2020 |
AZITHROMYCIN
ANDA #065398 |
SUPPL-7 |
AZITHROMYCIN |
LUPIN LTD |
Labeling |
Approval |
| 05/01/2020 |
AZITHROMYCIN
ANDA #065398 |
SUPPL-11 |
AZITHROMYCIN |
LUPIN LTD |
Labeling |
Approval |
| 05/01/2020 |
AZITHROMYCIN
ANDA #065398 |
SUPPL-13 |
AZITHROMYCIN |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
| 05/01/2020 |
AZITHROMYCIN
ANDA #065399 |
SUPPL-5 |
AZITHROMYCIN |
LUPIN LTD |
Labeling |
Approval |
| 05/01/2020 |
AZITHROMYCIN
ANDA #065399 |
SUPPL-7 |
AZITHROMYCIN |
LUPIN LTD |
Labeling |
Approval |
| 05/01/2020 |
AZITHROMYCIN
ANDA #065399 |
SUPPL-11 |
AZITHROMYCIN |
LUPIN LTD |
Labeling |
Approval |
| 05/01/2020 |
VALCHLOR
NDA #202317 |
SUPPL-10 |
MECHLORETHAMINE HYDROCHLORIDE |
HELSINN |
Labeling |
Approval |
| 05/01/2020 |
CARISOPRODOL
ANDA #207237 |
SUPPL-2 |
CARISOPRODOL |
NOSTRUM LABS INC |
Labeling |
Approval |
| 05/01/2020 |
AZITHROMYCIN
ANDA #207566 |
SUPPL-1 |
AZITHROMYCIN |
CSPC OUYI |
Labeling |
Approval |
| 05/01/2020 |
AZITHROMYCIN
ANDA #208250 |
SUPPL-1 |
AZITHROMYCIN |
CSPC OUYI |
Labeling |
Approval |
| 05/01/2020 |
AZITHROMYCIN
ANDA #209999 |
SUPPL-1 |
AZITHROMYCIN |
BIONPHARMA |
Labeling |
Approval |
| 05/01/2020 |
DAPAGLIFLOZIN
ANDA #211479 |
ORIG-1 |
METFORMIN HYDROCHLORIDE |
MSN LABS PVT LTD |
|
Tentative Approval |
| 05/01/2020 |
METHYLERGONOVINE MALEATE
ANDA #212233 |
ORIG-1 |
METHYLERGONOVINE MALEATE |
TULEX PHARMS INC |
|
Approval |
| 05/01/2020 |
FENSOLVI KIT
NDA #213150 |
ORIG-1 |
LEUPROLIDE ACETATE |
TOLMAR |
Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated |
Approval |
| 05/01/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #213662 |
ORIG-1 |
MINOCYCLINE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
|
Approval |
| 05/01/2020 |
FLUCYTOSINE
ANDA #213665 |
ORIG-1 |
FLUCYTOSINE |
AUROBINDO PHARMA LTD |
|
Approval |
| 05/01/2020 |
DARZALEX FASPRO
BLA #761145 |
ORIG-1 |
DARATUMUMAB;HYALURONIDASE-FIHJ |
JANSSEN BIOTECH |
|
Approval |
| 05/04/2020 |
METHOTREXATE SODIUM
NDA #008085 |
SUPPL-71 |
METHOTREXATE SODIUM |
STRIDES PHARMA |
Efficacy |
Approval |
| 05/04/2020 |
AMIODARONE HYDROCHLORIDE
ANDA #075761 |
SUPPL-17 |
AMIODARONE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 05/04/2020 |
TORSEMIDE
ANDA #076346 |
SUPPL-25 |
TORSEMIDE |
PLIVA PHARM IND |
Labeling |
Approval |
| 05/04/2020 |
BACLOFEN
ANDA #077121 |
SUPPL-2 |
BACLOFEN |
MYLAN |
Labeling |
Approval |
| 05/04/2020 |
BACLOFEN
ANDA #077181 |
SUPPL-2 |
BACLOFEN |
MYLAN |
Labeling |
Approval |
| 05/04/2020 |
TORSEMIDE
ANDA #078249 |
SUPPL-9 |
TORSEMIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 05/04/2020 |
AMPICILLIN AND SULBACTAM
ANDA #090578 |
SUPPL-3 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
ASTRAL |
Labeling |
Approval |
| 05/04/2020 |
AMPICILLIN AND SULBACTAM
ANDA #090578 |
SUPPL-4 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
ASTRAL |
Labeling |
Approval |
| 05/04/2020 |
AMPICILLIN AND SULBACTAM
ANDA #090579 |
SUPPL-4 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
ASTRAL |
Labeling |
Approval |
| 05/04/2020 |
AMPICILLIN AND SULBACTAM
ANDA #090579 |
SUPPL-5 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
ASTRAL |
Labeling |
Approval |
| 05/04/2020 |
CISATRACURIUM BESYLATE
ANDA #212190 |
ORIG-1 |
CISATRACURIUM BESYLATE |
PIRAMAL HLTHCARE UK |
|
Approval |
| 05/04/2020 |
ESOMEPRAZOLE MAGNESIUM
ANDA #212866 |
ORIG-1 |
ESOMEPRAZOLE MAGNESIUM |
SUN PHARM |
|
Approval |
| 05/04/2020 |
SUCCINYLCHOLINE CHLORIDE
ANDA #213810 |
ORIG-1 |
SUCCINYLCHOLINE CHLORIDE |
ASPIRO |
|
Approval |
| 05/05/2020 |
ACCURETIC
NDA #020125 |
SUPPL-25 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
PFIZER PHARMS |
Labeling |
Approval |
| 05/05/2020 |
DOXYCYCLINE HYCLATE
ANDA #062992 |
SUPPL-2 |
DOXYCYCLINE HYCLATE |
WEST-WARD PHARMS INT |
Labeling |
Approval |
| 05/05/2020 |
DOXYCYCLINE HYCLATE
ANDA #062992 |
SUPPL-3 |
DOXYCYCLINE HYCLATE |
WEST-WARD PHARMS INT |
Labeling |
Approval |
| 05/05/2020 |
DOXYCYCLINE HYCLATE
ANDA #062992 |
SUPPL-4 |
DOXYCYCLINE HYCLATE |
WEST-WARD PHARMS INT |
Labeling |
Approval |
| 05/05/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #063065 |
SUPPL-56 |
MINOCYCLINE HYDROCHLORIDE |
WATSON LABS |
Labeling |
Approval |
| 05/05/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #063065 |
SUPPL-58 |
MINOCYCLINE HYDROCHLORIDE |
WATSON LABS |
Labeling |
Approval |
| 05/05/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #063065 |
SUPPL-59 |
MINOCYCLINE HYDROCHLORIDE |
WATSON LABS |
Labeling |
Approval |
| 05/05/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #063181 |
SUPPL-52 |
MINOCYCLINE HYDROCHLORIDE |
WATSON LABS TEVA |
Labeling |
Approval |
| 05/05/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #063181 |
SUPPL-53 |
MINOCYCLINE HYDROCHLORIDE |
WATSON LABS TEVA |
Labeling |
Approval |
| 05/05/2020 |
MINOCYCLINE HYDROCHLORIDE
ANDA #063181 |
SUPPL-54 |
MINOCYCLINE HYDROCHLORIDE |
WATSON LABS TEVA |
Labeling |
Approval |
| 05/05/2020 |
SIMVASTATIN
ANDA #077691 |
SUPPL-40 |
SIMVASTATIN |
AUROBINDO PHARMA |
Labeling |
Approval |
| 05/05/2020 |
METHADONE HYDROCHLORIDE
ANDA #088108 |
SUPPL-21 |
METHADONE HYDROCHLORIDE |
ROXANE |
REMS |
Approval |
| 05/05/2020 |
METHADONE HYDROCHLORIDE
ANDA #088109 |
SUPPL-20 |
METHADONE HYDROCHLORIDE |
ROXANE |
REMS |
Approval |
| 05/05/2020 |
VALSARTAN
ANDA #090866 |
SUPPL-3 |
VALSARTAN |
MYLAN |
Labeling |
Approval |
| 05/05/2020 |
VALSARTAN
ANDA #090866 |
SUPPL-6 |
VALSARTAN |
MYLAN |
Labeling |
Approval |
| 05/05/2020 |
FARXIGA
NDA #202293 |
SUPPL-20 |
DAPAGLIFLOZIN |
ASTRAZENECA AB |
Efficacy |
Approval |
| 05/05/2020 |
VALSARTAN
ANDA #203536 |
SUPPL-2 |
VALSARTAN |
JUBILANT GENERICS |
Labeling |
Approval |
| 05/05/2020 |
VALSARTAN
ANDA #203536 |
SUPPL-4 |
VALSARTAN |
JUBILANT GENERICS |
Labeling |
Approval |
| 05/05/2020 |
VALSARTAN
ANDA #203536 |
SUPPL-7 |
VALSARTAN |
JUBILANT GENERICS |
Labeling |
Approval |
| 05/05/2020 |
METFORMIN HYDROCHLORIDE
ANDA #203769 |
SUPPL-18 |
METFORMIN HYDROCHLORIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 05/05/2020 |
DEFERASIROX
ANDA #208882 |
ORIG-1 |
DEFERASIROX |
ZYDUS PHARMS |
|
Approval |
| 05/05/2020 |
NIKITA
NDA #209875 |
SUPPL-1 |
PITAVASTATIN SODIUM |
LUPIN LTD |
Labeling |
Approval |
| 05/05/2020 |
ELYXYB
NDA #212157 |
ORIG-1 |
CELECOXIB |
SCILEX HLDG |
Type 3 - New Dosage Form |
Approval |
| 05/05/2020 |
RITUXAN HYCELA
BLA #761064 |
SUPPL-8 |
RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) |
GENENTECH INC |
|
Approval |
| 05/05/2020 |
RITUXAN HYCELA
BLA #761064 |
SUPPL-10 |
RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) |
GENENTECH INC |
|
Approval |
| 05/06/2020 |
AVELOX
NDA #021085 |
SUPPL-66 |
MOXIFLOXACIN HYDROCHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 05/06/2020 |
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
NDA #021277 |
SUPPL-62 |
MOXIFLOXACIN HYDROCHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 05/06/2020 |
BACLOFEN
ANDA #072234 |
SUPPL-38 |
BACLOFEN |
IVAX SUB TEVA PHARMS |
Labeling |
Approval |
| 05/06/2020 |
BACLOFEN
ANDA #072235 |
SUPPL-38 |
BACLOFEN |
IVAX SUB TEVA PHARMS |
Labeling |
Approval |
| 05/06/2020 |
BACLOFEN
ANDA #073092 |
SUPPL-16 |
BACLOFEN |
WATSON LABS |
Labeling |
Approval |
| 05/06/2020 |
BACLOFEN
ANDA #073093 |
SUPPL-14 |
BACLOFEN |
WATSON LABS |
Labeling |
Approval |
| 05/06/2020 |
BACLOFEN
ANDA #074698 |
SUPPL-3 |
BACLOFEN |
WATSON LABS |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-100
ANDA #077154 |
SUPPL-19 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-100
ANDA #077154 |
SUPPL-21 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-100
ANDA #077154 |
SUPPL-23 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-100
ANDA #077154 |
SUPPL-24 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-100
ANDA #077154 |
SUPPL-25 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-12
ANDA #077154 |
SUPPL-19 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-12
ANDA #077154 |
SUPPL-21 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-12
ANDA #077154 |
SUPPL-23 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-12
ANDA #077154 |
SUPPL-24 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-12
ANDA #077154 |
SUPPL-25 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-25
ANDA #077154 |
SUPPL-19 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-25
ANDA #077154 |
SUPPL-21 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-25
ANDA #077154 |
SUPPL-23 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-25
ANDA #077154 |
SUPPL-24 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-25
ANDA #077154 |
SUPPL-25 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-37
ANDA #077154 |
SUPPL-19 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-37
ANDA #077154 |
SUPPL-21 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-37
ANDA #077154 |
SUPPL-23 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-37
ANDA #077154 |
SUPPL-24 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-37
ANDA #077154 |
SUPPL-25 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-50
ANDA #077154 |
SUPPL-19 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-50
ANDA #077154 |
SUPPL-21 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-50
ANDA #077154 |
SUPPL-23 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-50
ANDA #077154 |
SUPPL-24 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-50
ANDA #077154 |
SUPPL-25 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-62
ANDA #077154 |
SUPPL-19 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-62
ANDA #077154 |
SUPPL-21 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-62
ANDA #077154 |
SUPPL-23 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-62
ANDA #077154 |
SUPPL-24 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-62
ANDA #077154 |
SUPPL-25 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-75
ANDA #077154 |
SUPPL-19 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-75
ANDA #077154 |
SUPPL-21 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-75
ANDA #077154 |
SUPPL-23 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-75
ANDA #077154 |
SUPPL-24 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
FENTANYL-75
ANDA #077154 |
SUPPL-25 |
FENTANYL |
SPECGX LLC |
Labeling |
Approval |
| 05/06/2020 |
REPATHA
BLA #125522 |
SUPPL-24 |
EVOLOCUMAB |
AMGEN INC |
|
Approval |
| 05/06/2020 |
DABIGATRAN ETEXILATE MESYLATE
ANDA #207961 |
ORIG-1 |
DABIGATRAN ETEXILATE MESYLATE |
HETERO LABS LTD III |
|
Approval |
| 05/06/2020 |
DABIGATRAN ETEXILATE MESYLATE
ANDA #207961 |
ORIG-2 |
DABIGATRAN ETEXILATE MESYLATE |
HETERO LABS LTD III |
|
Tentative Approval |
| 05/06/2020 |
IVERMECTIN
ANDA #210720 |
ORIG-1 |
IVERMECTIN |
TARO |
|
Approval |
| 05/06/2020 |
BACLOFEN
ANDA #211555 |
SUPPL-2 |
BACLOFEN |
EYWA PHARMA |
Labeling |
Approval |
| 05/06/2020 |
TABRECTA
NDA #213591 |
ORIG-1 |
CAPMATINIB HYDROCHLORIDE |
NOVARTIS PHARM |
Type 1 - New Molecular Entity |
Approval |
| 05/07/2020 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #200180 |
SUPPL-2 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
WATSON LABS |
Labeling |
Approval |
| 05/07/2020 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
ANDA #200180 |
SUPPL-3 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
WATSON LABS |
Labeling |
Approval |
| 05/07/2020 |
KYPROLIS
NDA #202714 |
SUPPL-29 |
CARFILZOMIB |
ONYX PHARMS AMGEN |
Labeling |
Approval |
| 05/07/2020 |
OLOPATADINE HYDROCHLORIDE
ANDA #209619 |
SUPPL-1 |
OLOPATADINE HYDROCHLORIDE |
GLAND PHARMA LTD |
Labeling |
Approval |
| 05/07/2020 |
FENTANYL CITRATE PRESERVATIVE FREE
ANDA #210762 |
SUPPL-1 |
FENTANYL CITRATE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 05/07/2020 |
LIDOCAINE HYDROCHLORIDE
ANDA #212821 |
ORIG-1 |
LIDOCAINE HYDROCHLORIDE |
HUONS |
|
Approval |
| 05/07/2020 |
TRAZIMERA
BLA #761081 |
SUPPL-6 |
TRASTUZUMAB-QYYP |
PFIZER INC |
|
Approval |
| 05/08/2020 |
CIPRO
NDA #019537 |
SUPPL-91 |
CIPROFLOXACIN HYDROCHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 05/08/2020 |
CIPRO
NDA #019847 |
SUPPL-62 |
CIPROFLOXACIN |
BAYER HLTHCARE |
Labeling |
Approval |
| 05/08/2020 |
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019857 |
SUPPL-72 |
CIPROFLOXACIN |
BAYER HLTHCARE |
Labeling |
Approval |
| 05/08/2020 |
ALEVE
NDA #020204 |
SUPPL-72 |
NAPROXEN SODIUM |
BAYER |
Labeling |
Approval |
| 05/08/2020 |
VISIPAQUE 270
NDA #020351 |
SUPPL-52 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
| 05/08/2020 |
VISIPAQUE 320
NDA #020351 |
SUPPL-52 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
| 05/08/2020 |
CIPRO
NDA #020780 |
SUPPL-48 |
CIPROFLOXACIN |
BAYER HLTHCARE |
Labeling |
Approval |
| 05/08/2020 |
CIPRO XR
NDA #021473 |
SUPPL-42 |
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 05/08/2020 |
VIVITROL
NDA #021897 |
SUPPL-49 |
NALTREXONE |
ALKERMES |
Labeling |
Approval |
| 05/08/2020 |
TOBRAMYCIN
ANDA #064052 |
SUPPL-32 |
TOBRAMYCIN |
BAUSCH AND LOMB |
Labeling |
Approval |
| 05/08/2020 |
PROGESTERONE
ANDA #091033 |
SUPPL-4 |
PROGESTERONE |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 05/08/2020 |
RASAGILINE MESYLATE
ANDA #201892 |
SUPPL-1 |
RASAGILINE MESYLATE |
CHARTWELL RX |
Labeling |
Approval |
| 05/08/2020 |
URSODIOL
ANDA #205789 |
ORIG-1 |
URSODIOL |
LGM PHARMA |
|
Approval |
| 05/08/2020 |
SMOFLIPID 20%
NDA #207648 |
SUPPL-3 |
FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL |
FRESENIUS KABI USA |
Labeling |
Approval |
| 05/08/2020 |
LYNPARZA
NDA #208558 |
SUPPL-13 |
OLAPARIB |
ASTRAZENECA |
Efficacy |
Approval |
| 05/08/2020 |
CISATRACURIUM BESYLATE
ANDA #209144 |
ORIG-1 |
CISATRACURIUM BESYLATE |
EUGIA PHARMA |
|
Approval |
| 05/08/2020 |
MELPHALAN HYDROCHLORIDE
ANDA #209197 |
ORIG-1 |
MELPHALAN HYDROCHLORIDE |
BPI LABS |
|
Approval |
| 05/08/2020 |
OMEGAVEN
NDA #210589 |
SUPPL-1 |
FISH OIL TRIGLYCERIDES |
FRESENIUS KABI USA |
Labeling |
Approval |
| 05/08/2020 |
AZITHROMYCIN
ANDA #211068 |
ORIG-1 |
AZITHROMYCIN |
YUNG SHIN PHARM |
|
Approval |
| 05/08/2020 |
AZELASTINE HYDROCHLORIDE
ANDA #212289 |
ORIG-1 |
AZELASTINE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
|
Approval |
| 05/08/2020 |
POTASSIUM CHLORIDE
ANDA #212861 |
ORIG-1 |
POTASSIUM CHLORIDE |
AMNEAL |
|
Approval |
| 05/08/2020 |
RETEVMO
NDA #213246 |
ORIG-1 |
SELPERCATINIB |
LOXO ONCOL ELI LILLY |
Type 1 - New Molecular Entity |
Approval |
| 05/08/2020 |
GUAIFENESIN
ANDA #213420 |
ORIG-1 |
GUAIFENESIN |
GRANULES |
|
Approval |
| 05/08/2020 |
IBUPROFEN
ANDA #213794 |
ORIG-1 |
IBUPROFEN |
AUROBINDO PHARMA LTD |
|
Approval |
| 05/10/2020 |
CEFOTAXIME
ANDA #065197 |
SUPPL-3 |
CEFOTAXIME SODIUM |
WOCKHARDT |
Labeling |
Approval |
| 05/10/2020 |
CEFOTAXIME SODIUM
ANDA #065197 |
SUPPL-3 |
CEFOTAXIME SODIUM |
WOCKHARDT |
Labeling |
Approval |
| 05/11/2020 |
ANDRODERM
NDA #020489 |
SUPPL-36 |
TESTOSTERONE |
ABBVIE |
Labeling |
Approval |
| 05/11/2020 |
RILUTEK
NDA #020599 |
SUPPL-19 |
RILUZOLE |
COVIS |
Labeling |
Approval |
| 05/11/2020 |
FOSRENOL
NDA #021468 |
SUPPL-23 |
LANTHANUM CARBONATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 05/11/2020 |
VIGAMOX
NDA #021598 |
SUPPL-23 |
MOXIFLOXACIN HYDROCHLORIDE |
HARROW EYE |
Labeling |
Approval |
| 05/11/2020 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040081 |
SUPPL-30 |
HYDROXYCHLOROQUINE SULFATE |
TEVA PHARMS |
Labeling |
Approval |
| 05/11/2020 |
BICALUTAMIDE
ANDA #078575 |
SUPPL-5 |
BICALUTAMIDE |
SANDOZ |
Labeling |
Approval |
| 05/11/2020 |
BICALUTAMIDE
ANDA #078575 |
SUPPL-6 |
BICALUTAMIDE |
SANDOZ |
Labeling |
Approval |
| 05/11/2020 |
FAMOTIDINE
ANDA #078916 |
SUPPL-5 |
FAMOTIDINE |
ALEMBIC PHARMS LTD |
Labeling |
Approval |
| 05/11/2020 |
FAMOTIDINE
ANDA #078916 |
SUPPL-6 |
FAMOTIDINE |
ALEMBIC PHARMS LTD |
Labeling |
Approval |
| 05/11/2020 |
FAMOTIDINE
ANDA #090283 |
SUPPL-12 |
FAMOTIDINE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 05/11/2020 |
DESONIDE
ANDA #202470 |
ORIG-1 |
DESONIDE |
CINTEX SVCS |
|
Approval |
| 05/11/2020 |
FOSRENOL
NDA #204734 |
SUPPL-5 |
LANTHANUM CARBONATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 05/11/2020 |
DOXYCYCLINE HYCLATE
ANDA #206772 |
SUPPL-3 |
DOXYCYCLINE HYCLATE |
ZYDUS PHARMS |
Labeling |
Approval |
| 05/11/2020 |
TIGLUTIK KIT
NDA #209080 |
SUPPL-3 |
RILUZOLE |
ITALFARMACO SA |
Labeling |
Approval |
| 05/11/2020 |
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
ANDA #210765 |
ORIG-1 |
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE |
COSETTE |
|
Approval |
| 05/11/2020 |
TEGSEDI
NDA #211172 |
SUPPL-6 |
INOTERSEN SODIUM |
AKCEA THERAPS |
REMS |
Approval |
| 05/11/2020 |
TRAMADOL HYDROCHLORIDE
ANDA #211825 |
SUPPL-2 |
TRAMADOL HYDROCHLORIDE |
UNICHEM |
Labeling |
Approval |
| 05/11/2020 |
FLUVOXAMINE MALEATE
ANDA #212182 |
ORIG-1 |
FLUVOXAMINE MALEATE |
BIONPHARMA |
|
Approval |
| 05/11/2020 |
EXSERVAN
NDA #212640 |
SUPPL-1 |
RILUZOLE |
AQUESTIVE |
Labeling |
Approval |
| 05/12/2020 |
WELCHOL
NDA #021176 |
SUPPL-47 |
COLESEVELAM HYDROCHLORIDE |
COSETTE |
Labeling |
Approval |
| 05/12/2020 |
WELCHOL
NDA #022362 |
SUPPL-27 |
COLESEVELAM HYDROCHLORIDE |
COSETTE |
Labeling |
Approval |
| 05/12/2020 |
RIFADIN
NDA #050420 |
SUPPL-84 |
RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 05/12/2020 |
RIFADIN
NDA #050627 |
SUPPL-27 |
RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 05/12/2020 |
RIFATER
NDA #050705 |
SUPPL-18 |
ISONIAZID; PYRAZINAMIDE; RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
| 05/12/2020 |
AMBISOME
NDA #050740 |
SUPPL-31 |
AMPHOTERICIN B |
ASTELLAS |
Labeling |
Approval |
| 05/12/2020 |
CEFDINIR
ANDA #065337 |
SUPPL-12 |
CEFDINIR |
SANDOZ |
Labeling |
Approval |
| 05/12/2020 |
CEFDINIR
ANDA #065337 |
SUPPL-15 |
CEFDINIR |
SANDOZ |
Labeling |
Approval |
| 05/12/2020 |
CEFDINIR
ANDA #065429 |
SUPPL-5 |
CEFDINIR |
ANDA REPOSITORY |
Labeling |
Approval |
| 05/12/2020 |
FAMOTIDINE
ANDA #075611 |
SUPPL-10 |
FAMOTIDINE |
APOTEX |
Labeling |
Approval |
| 05/12/2020 |
FAMOTIDINE
ANDA #075611 |
SUPPL-11 |
FAMOTIDINE |
APOTEX |
Labeling |
Approval |
| 05/12/2020 |
ISOSORBIDE DINITRATE
ANDA #088088 |
SUPPL-41 |
ISOSORBIDE DINITRATE |
HIKMA INTL PHARMS |
Manufacturing (CMC) |
Approval |
| 05/12/2020 |
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
NDA #202106 |
SUPPL-7 |
MEROPENEM |
B BRAUN MEDICAL INC |
Labeling |
Approval |
| 05/12/2020 |
CONSENSI
NDA #210045 |
SUPPL-6 |
AMLODIPINE BESYLATE; CELECOXIB |
PURPLE BIOTECH |
Labeling |
Approval |
| 05/12/2020 |
WELCHOL
NDA #210895 |
SUPPL-1 |
COLESEVELAM HYDROCHLORIDE |
COSETTE |
Labeling |
Approval |
| 05/12/2020 |
OMEGA-3-ACID ETHYL ESTERS
ANDA #211979 |
ORIG-1 |
OMEGA-3-ACID ETHYL ESTERS |
CSPC-NBP PHARM |
|
Approval |
| 05/13/2020 |
FASLODEX
NDA #021344 |
SUPPL-41 |
FULVESTRANT |
ASTRAZENECA |
Efficacy |
Approval |
| 05/13/2020 |
FAMOTIDINE
ANDA #075607 |
SUPPL-1 |
FAMOTIDINE |
SANDOZ |
Labeling |
Approval |
| 05/13/2020 |
FAMOTIDINE
ANDA #075704 |
SUPPL-18 |
FAMOTIDINE |
RISING |
Labeling |
Approval |
| 05/13/2020 |
FAMOTIDINE
ANDA #075704 |
SUPPL-19 |
FAMOTIDINE |
RISING |
Labeling |
Approval |
| 05/13/2020 |
FAMOTIDINE
ANDA #075805 |
SUPPL-9 |
FAMOTIDINE |
CARLSBAD |
Labeling |
Approval |
| 05/13/2020 |
LISINOPRIL
ANDA #076063 |
SUPPL-65 |
LISINOPRIL |
HIKMA INTL PHARMS |
Labeling |
Approval |
| 05/13/2020 |
LISINOPRIL
ANDA #077622 |
SUPPL-25 |
LISINOPRIL |
AUROBINDO |
Labeling |
Approval |
| 05/13/2020 |
LISINOPRIL
ANDA #078402 |
SUPPL-9 |
LISINOPRIL |
WOCKHARDT BIO AG |
Labeling |
Approval |
| 05/13/2020 |
CELECOXIB
ANDA #213598 |
ORIG-1 |
CELECOXIB |
NANJING |
|
Approval |
| 05/14/2020 |
COPAXONE
NDA #020622 |
SUPPL-109 |
GLATIRAMER ACETATE |
TEVA PHARMS USA |
Labeling |
Approval |
| 05/14/2020 |
COLCRYS
NDA #022352 |
SUPPL-26 |
COLCHICINE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 05/14/2020 |
FOLOTYN
NDA #022468 |
SUPPL-13 |
PRALATREXATE |
ACROTECH BIOPHARMA |
Labeling |
Approval |
| 05/14/2020 |
AMPICILLIN AND SULBACTAM
ANDA #065240 |
SUPPL-17 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
SANDOZ |
Labeling |
Approval |
| 05/14/2020 |
AMPICILLIN AND SULBACTAM
ANDA #065240 |
SUPPL-19 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
SANDOZ |
Labeling |
Approval |
| 05/14/2020 |
AMPICILLIN AND SULBACTAM
ANDA #065241 |
SUPPL-17 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
SANDOZ |
Labeling |
Approval |
| 05/14/2020 |
AMPICILLIN AND SULBACTAM
ANDA #065241 |
SUPPL-19 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
SANDOZ |
Labeling |
Approval |
| 05/14/2020 |
SIMVASTATIN
ANDA #077837 |
SUPPL-40 |
SIMVASTATIN |
ZYDUS PHARMS USA |
Labeling |
Approval |
| 05/14/2020 |
REMICADE
BLA #103772 |
SUPPL-5389 |
INFLIXIMAB |
CENTOCOR INC |
|
Approval |
| 05/14/2020 |
REMICADE
BLA #103772 |
SUPPL-5391 |
INFLIXIMAB |
CENTOCOR INC |
|
Approval |
| 05/14/2020 |
REMICADE
BLA #103772 |
SUPPL-5394 |
INFLIXIMAB |
CENTOCOR INC |
|
Approval |
| 05/14/2020 |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
ANDA #203048 |
SUPPL-1 |
CLINDAMYCIN PHOSPHATE |
RISING |
Labeling |
Approval |
| 05/14/2020 |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
ANDA #203048 |
SUPPL-2 |
CLINDAMYCIN PHOSPHATE |
RISING |
Labeling |
Approval |
| 05/14/2020 |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
ANDA #203048 |
SUPPL-3 |
CLINDAMYCIN PHOSPHATE |
RISING |
Labeling |
Approval |
| 05/14/2020 |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
ANDA #203048 |
SUPPL-4 |
CLINDAMYCIN PHOSPHATE |
RISING |
Labeling |
Approval |
| 05/14/2020 |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
ANDA #203048 |
SUPPL-8 |
CLINDAMYCIN PHOSPHATE |
RISING |
Labeling |
Approval |
| 05/14/2020 |
POMALYST
NDA #204026 |
SUPPL-23 |
POMALIDOMIDE |
BRISTOL |
Efficacy |
Approval |
| 05/14/2020 |
POMALYST
NDA #204026 |
SUPPL-24 |
POMALIDOMIDE |
BRISTOL |
Efficacy |
Approval |
| 05/14/2020 |
CINACALCET HYDROCHLORIDE
ANDA #206125 |
SUPPL-3 |
CINACALCET HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 05/14/2020 |
SIMVASTATIN
ANDA #206557 |
SUPPL-4 |
SIMVASTATIN |
INVAGEN PHARMS |
Labeling |
Approval |
| 05/14/2020 |
LICART
NDA #206976 |
SUPPL-2 |
DICLOFENAC EPOLAMINE |
IBSA INST BIO |
Labeling |
Approval |
| 05/14/2020 |
AZITHROMYCIN
ANDA #207370 |
SUPPL-4 |
AZITHROMYCIN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 05/14/2020 |
AZITHROMYCIN
ANDA #207398 |
SUPPL-4 |
AZITHROMYCIN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 05/14/2020 |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
ANDA #208084 |
SUPPL-2 |
CLINDAMYCIN PHOSPHATE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 05/14/2020 |
PEMETREXED FOR INJECTION
NDA #208297 |
ORIG-1 |
PEMETREXED |
DR REDDYS LABS INC |
Type 5 - New Formulation or New Manufacturer |
Tentative Approval |
| 05/14/2020 |
DOXYCYCLINE HYCLATE
ANDA #210536 |
ORIG-1 |
DOXYCYCLINE HYCLATE |
ALEMBIC |
|
Approval |
| 05/14/2020 |
VERAPAMIL HYDROCHLORIDE
ANDA #211015 |
SUPPL-1 |
VERAPAMIL HYDROCHLORIDE |
SOMERSET THERAPS LLC |
Labeling |
Approval |
| 05/14/2020 |
VERAPAMIL HYDROCHLORIDE
ANDA #211015 |
SUPPL-2 |
VERAPAMIL HYDROCHLORIDE |
SOMERSET THERAPS LLC |
Labeling |
Approval |
| 05/14/2020 |
VERAPAMIL HYDROCHLORIDE
ANDA #211015 |
SUPPL-3 |
VERAPAMIL HYDROCHLORIDE |
SOMERSET THERAPS LLC |
Labeling |
Approval |
| 05/14/2020 |
VERAPAMIL HYDROCHLORIDE
ANDA #211370 |
SUPPL-1 |
VERAPAMIL HYDROCHLORIDE |
MICRO LABS |
Labeling |
Approval |
| 05/14/2020 |
ESOMEPRAZOLE MAGNESIUM
ANDA #211571 |
ORIG-1 |
ESOMEPRAZOLE MAGNESIUM |
DR REDDYS |
|
Approval |
| 05/14/2020 |
DEFERASIROX
ANDA #211641 |
SUPPL-1 |
DEFERASIROX |
SUN PHARM |
Labeling |
Approval |
| 05/14/2020 |
NICOTINE POLACRILEX
ANDA #212057 |
ORIG-1 |
NICOTINE POLACRILEX |
P AND L |
|
Approval |
| 05/14/2020 |
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #212786 |
ORIG-1 |
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
LAURUS |
|
Approval |
| 05/14/2020 |
HYDROXYCHLOROQUINE SULFATE
ANDA #212902 |
ORIG-1 |
HYDROXYCHLOROQUINE SULFATE |
SENORES PHARMS |
|
Approval |
| 05/14/2020 |
IRINOTECAN HYDROCHLORIDE
ANDA #212993 |
SUPPL-1 |
IRINOTECAN HYDROCHLORIDE |
GLAND PHARMA LTD |
Labeling |
Approval |
| 05/14/2020 |
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #213038 |
ORIG-1 |
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
LAURUS |
|
Approval |
| 05/14/2020 |
ALBUTEROL SULFATE
ANDA #213657 |
ORIG-1 |
ALBUTEROL SULFATE |
AUROBINDO PHARMA LTD |
|
Approval |
| 05/15/2020 |
TAXOTERE
NDA #020449 |
SUPPL-84 |
DOCETAXEL |
SANOFI AVENTIS US |
Labeling |
Approval |
| 05/15/2020 |
EPINEPHRINE (AUTOINJECTOR)
ANDA #090589 |
SUPPL-7 |
EPINEPHRINE |
TEVA PHARMS USA |
Labeling |
Approval |
| 05/15/2020 |
LEVOFLOXACIN
ANDA #091644 |
SUPPL-5 |
LEVOFLOXACIN |
RISING |
Labeling |
Approval |
| 05/15/2020 |
LEVOFLOXACIN
ANDA #091644 |
SUPPL-6 |
LEVOFLOXACIN |
RISING |
Labeling |
Approval |
| 05/15/2020 |
YERVOY
BLA #125377 |
SUPPL-109 |
IPILIMUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 05/15/2020 |
MYALEPT
BLA #125390 |
SUPPL-16 |
METRELEPTIN |
AMRYT |
|
Approval |
| 05/15/2020 |
OPDIVO
BLA #125554 |
SUPPL-80 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 05/15/2020 |
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
ANDA #203442 |
ORIG-1 |
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
MACLEODS PHARMS LTD |
|
Approval |
| 05/15/2020 |
POSACONAZOLE
ANDA #208773 |
ORIG-1 |
POSACONAZOLE |
HIKMA |
|
Approval |
| 05/15/2020 |
RUBRACA
NDA #209115 |
SUPPL-4 |
RUCAPARIB CAMSYLATE |
ZR PHARMA |
Efficacy |
Approval |
| 05/15/2020 |
ARSENIC TRIOXIDE
ANDA #209315 |
SUPPL-2 |
ARSENIC TRIOXIDE |
INGENUS PHARMS LLC |
Labeling |
Approval |
| 05/15/2020 |
CINACALCET HYDROCHLORIDE
ANDA #211892 |
ORIG-1 |
CINACALCET HYDROCHLORIDE |
ACCORD HLTHCARE |
|
Approval |
| 05/15/2020 |
QINLOCK
NDA #213973 |
ORIG-1 |
RIPRETINIB |
DECIPHERA PHARMS |
Type 1 - New Molecular Entity |
Approval |
| 05/15/2020 |
OCREVUS
BLA #761053 |
SUPPL-24 |
OCRELIZUMAB |
GENENTECH INC |
|
Approval |
| 05/17/2020 |
AZITHROMYCIN
ANDA #065153 |
SUPPL-21 |
AZITHROMYCIN |
TEVA |
Labeling |
Approval |
| 05/17/2020 |
AZITHROMYCIN
ANDA #065153 |
SUPPL-23 |
AZITHROMYCIN |
TEVA |
Labeling |
Approval |
| 05/17/2020 |
AZITHROMYCIN
ANDA #065193 |
SUPPL-22 |
AZITHROMYCIN |
TEVA |
Labeling |
Approval |
| 05/17/2020 |
AZITHROMYCIN
ANDA #065193 |
SUPPL-24 |
AZITHROMYCIN |
TEVA |
Labeling |
Approval |
| 05/18/2020 |
ACCUPRIL
NDA #019885 |
SUPPL-45 |
QUINAPRIL HYDROCHLORIDE |
PFIZER PHARMS |
Labeling |
Approval |
| 05/18/2020 |
TOBREX
ANDA #062535 |
SUPPL-30 |
TOBRAMYCIN |
SANDOZ |
Labeling |
Approval |
| 05/18/2020 |
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
ANDA #064211 |
SUPPL-16 |
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE |
SANDOZ |
Labeling |
Approval |
| 05/18/2020 |
AZITHROMYCIN
ANDA #065365 |
SUPPL-10 |
AZITHROMYCIN |
MYLAN |
Labeling |
Approval |
| 05/18/2020 |
AZITHROMYCIN
ANDA #065365 |
SUPPL-11 |
AZITHROMYCIN |
MYLAN |
Labeling |
Approval |
| 05/18/2020 |
AZITHROMYCIN
ANDA #065366 |
SUPPL-9 |
AZITHROMYCIN |
MYLAN |
Labeling |
Approval |
| 05/18/2020 |
AZITHROMYCIN
ANDA #065366 |
SUPPL-10 |
AZITHROMYCIN |
MYLAN |
Labeling |
Approval |
| 05/18/2020 |
VERAPAMIL HYDROCHLORIDE
ANDA #074587 |
SUPPL-42 |
VERAPAMIL HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 05/18/2020 |
MEGESTROL ACETATE
ANDA #075997 |
SUPPL-16 |
MEGESTROL ACETATE |
HIKMA |
Labeling |
Approval |
| 05/18/2020 |
TRAZODONE HYDROCHLORIDE
ANDA #090514 |
SUPPL-6 |
TRAZODONE HYDROCHLORIDE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 05/18/2020 |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
ANDA #201692 |
SUPPL-5 |
CLINDAMYCIN PHOSPHATE |
SANDOZ INC |
Labeling |
Approval |
| 05/18/2020 |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
ANDA #201692 |
SUPPL-7 |
CLINDAMYCIN PHOSPHATE |
SANDOZ INC |
Labeling |
Approval |
| 05/18/2020 |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
ANDA #201692 |
SUPPL-8 |
CLINDAMYCIN PHOSPHATE |
SANDOZ INC |
Labeling |
Approval |
| 05/18/2020 |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
ANDA #201692 |
SUPPL-12 |
CLINDAMYCIN PHOSPHATE |
SANDOZ INC |
Labeling |
Approval |
| 05/18/2020 |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
ANDA #201692 |
SUPPL-16 |
CLINDAMYCIN PHOSPHATE |
SANDOZ INC |
Labeling |
Approval |
| 05/18/2020 |
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
ANDA #201692 |
SUPPL-18 |
CLINDAMYCIN PHOSPHATE |
SANDOZ INC |
Labeling |
Approval |
| 05/18/2020 |
ZELBORAF
NDA #202429 |
SUPPL-19 |
VEMURAFENIB |
HOFFMANN LA ROCHE |
Labeling |
Approval |
| 05/18/2020 |
LANSOPRAZOLE
ANDA #203083 |
ORIG-1 |
LANSOPRAZOLE |
HETERO LABS LTD III |
|
Approval |
| 05/18/2020 |
CINACALCET HYDROCHLORIDE
ANDA #207008 |
SUPPL-1 |
CINACALCET HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 05/18/2020 |
CINACALCET HYDROCHLORIDE
ANDA #207008 |
SUPPL-2 |
CINACALCET HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 05/18/2020 |
GANCICLOVIR SODIUM
ANDA #207645 |
SUPPL-1 |
GANCICLOVIR SODIUM |
PHARMASCIENCE INC |
Labeling |
Approval |
| 05/18/2020 |
FINGOLIMOD HYDROCHLORIDE
ANDA #207933 |
ORIG-1 |
FINGOLIMOD HYDROCHLORIDE |
HETERO LABS LTD V |
|
Approval |
| 05/18/2020 |
ABIRATERONE ACETATE
ANDA #208416 |
ORIG-1 |
ABIRATERONE ACETATE |
DR REDDYS |
|
Approval |
| 05/18/2020 |
OLMESARTAN MEDOXOMIL
ANDA #208659 |
ORIG-1 |
OLMESARTAN MEDOXOMIL |
INVENTIA |
|
Approval |
| 05/18/2020 |
CINACALCET HYDROCHLORIDE
ANDA #209226 |
SUPPL-3 |
CINACALCET HYDROCHLORIDE |
STRIDES PHARMA |
Labeling |
Approval |
| 05/18/2020 |
CINACALCET HYDROCHLORIDE
ANDA #209226 |
SUPPL-4 |
CINACALCET HYDROCHLORIDE |
STRIDES PHARMA |
Labeling |
Approval |
| 05/18/2020 |
CINACALCET HYDROCHLORIDE
ANDA #210207 |
SUPPL-3 |
CINACALCET HYDROCHLORIDE |
SLATE RUN PHARMA |
Labeling |
Approval |
| 05/18/2020 |
CLOBETASOL PROPIONATE
ANDA #213290 |
ORIG-1 |
CLOBETASOL PROPIONATE |
ALEMBIC |
|
Approval |
| 05/18/2020 |
CINACALCET HYDROCHLORIDE
ANDA #213325 |
ORIG-1 |
CINACALCET HYDROCHLORIDE |
CHARTWELL RX |
|
Approval |
| 05/18/2020 |
TECENTRIQ
BLA #761034 |
SUPPL-27 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
| 05/19/2020 |
DEPAKENE
NDA #018081 |
SUPPL-71 |
VALPROIC ACID |
ABBVIE |
Labeling |
Approval |
| 05/19/2020 |
DEPAKENE
NDA #018082 |
SUPPL-54 |
VALPROIC ACID |
ABBVIE |
Labeling |
Approval |
| 05/19/2020 |
DEPAKOTE
NDA #018723 |
SUPPL-63 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
| 05/19/2020 |
DEPAKOTE
NDA #019680 |
SUPPL-50 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
| 05/19/2020 |
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019830 |
SUPPL-27 |
LIDOCAINE HYDROCHLORIDE |
B BRAUN |
Labeling |
Approval |
| 05/19/2020 |
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019830 |
SUPPL-27 |
LIDOCAINE HYDROCHLORIDE |
B BRAUN |
Labeling |
Approval |
| 05/19/2020 |
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019830 |
SUPPL-27 |
LIDOCAINE HYDROCHLORIDE |
B BRAUN |
Labeling |
Approval |
| 05/19/2020 |
DEPACON
NDA #020593 |
SUPPL-41 |
VALPROATE SODIUM |
ABBVIE |
Labeling |
Approval |
| 05/19/2020 |
DEPAKOTE ER
NDA #021168 |
SUPPL-41 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
| 05/19/2020 |
MINOXIDIL
ANDA #071344 |
SUPPL-37 |
MINOXIDIL |
WATSON LABS |
Labeling |
Approval |
| 05/19/2020 |
MINOXIDIL
ANDA #071345 |
SUPPL-38 |
MINOXIDIL |
WATSON LABS |
Labeling |
Approval |
| 05/19/2020 |
TRAZODONE HYDROCHLORIDE
ANDA #072192 |
SUPPL-51 |
TRAZODONE HYDROCHLORIDE |
OXFORD PHARMS |
Labeling |
Approval |
| 05/19/2020 |
TRAZODONE HYDROCHLORIDE
ANDA #072192 |
SUPPL-54 |
TRAZODONE HYDROCHLORIDE |
OXFORD PHARMS |
Labeling |
Approval |
| 05/19/2020 |
TRAZODONE HYDROCHLORIDE
ANDA #072193 |
SUPPL-53 |
TRAZODONE HYDROCHLORIDE |
OXFORD PHARMS |
Labeling |
Approval |
| 05/19/2020 |
TRAZODONE HYDROCHLORIDE
ANDA #072193 |
SUPPL-56 |
TRAZODONE HYDROCHLORIDE |
OXFORD PHARMS |
Labeling |
Approval |
| 05/19/2020 |
CAPTOPRIL
ANDA #074477 |
SUPPL-3 |
CAPTOPRIL |
PRINSTON INC |
Labeling |
Approval |
| 05/19/2020 |
MEGESTROL ACETATE
ANDA #075671 |
SUPPL-23 |
MEGESTROL ACETATE |
STRIDES PHARMA |
Labeling |
Approval |
| 05/19/2020 |
CLOPIDOGREL BISULFATE
ANDA #078133 |
SUPPL-2 |
CLOPIDOGREL BISULFATE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 05/19/2020 |
CLOPIDOGREL BISULFATE
ANDA #078133 |
SUPPL-3 |
CLOPIDOGREL BISULFATE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 05/19/2020 |
AMPICILLIN AND SULBACTAM
ANDA #090340 |
SUPPL-7 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
EUGIA PHARMA SPECLTS |
Labeling |
Approval |
| 05/19/2020 |
CLOPIDOGREL BISULFATE
ANDA #091216 |
SUPPL-1 |
CLOPIDOGREL BISULFATE |
ANI PHARMS |
Labeling |
Approval |
| 05/19/2020 |
CLOPIDOGREL BISULFATE
ANDA #091216 |
SUPPL-2 |
CLOPIDOGREL BISULFATE |
ANI PHARMS |
Labeling |
Approval |
| 05/19/2020 |
MESALAMINE
ANDA #091640 |
SUPPL-3 |
MESALAMINE |
ZYDUS PHARMS |
Labeling |
Approval |
| 05/19/2020 |
MESALAMINE
ANDA #091640 |
SUPPL-4 |
MESALAMINE |
ZYDUS PHARMS |
Labeling |
Approval |
| 05/19/2020 |
MESALAMINE
ANDA #091640 |
SUPPL-7 |
MESALAMINE |
ZYDUS PHARMS |
Labeling |
Approval |
| 05/19/2020 |
MESALAMINE
ANDA #091640 |
SUPPL-10 |
MESALAMINE |
ZYDUS PHARMS |
Labeling |
Approval |
| 05/19/2020 |
TOLVAPTAN
ANDA #207605 |
ORIG-1 |
TOLVAPTAN |
APOTEX |
|
Approval |
| 05/19/2020 |
LYNPARZA
NDA #208558 |
SUPPL-14 |
OLAPARIB |
ASTRAZENECA |
Efficacy |
Approval |
| 05/19/2020 |
SUCCINYLCHOLINE CHLORIDE
ANDA #211625 |
ORIG-1 |
SUCCINYLCHOLINE CHLORIDE |
NIVAGEN PHARMS INC |
|
Approval |
| 05/19/2020 |
MESALAMINE
ANDA #211858 |
SUPPL-1 |
MESALAMINE |
SUN PHARM |
Labeling |
Approval |
| 05/19/2020 |
TOLVAPTAN
ANDA #211891 |
ORIG-1 |
TOLVAPTAN |
ALKEM LABS LTD |
|
Approval |
| 05/19/2020 |
FERRIPROX
NDA #212269 |
ORIG-1 |
DEFERIPRONE |
CHIESI |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 05/19/2020 |
TOLTERODINE TARTRATE
ANDA #213397 |
ORIG-1 |
TOLTERODINE TARTRATE |
AJANTA PHARMA LTD |
|
Approval |
| 05/19/2020 |
IMPEKLO
NDA #213691 |
ORIG-1 |
CLOBETASOL PROPIONATE |
MYLAN |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 05/20/2020 |
CYTOVENE
NDA #019661 |
SUPPL-38 |
GANCICLOVIR SODIUM |
CHEPLAPHARM |
Labeling |
Approval |
| 05/20/2020 |
CLOPIDOGREL BISULFATE
ANDA #078004 |
SUPPL-2 |
CLOPIDOGREL BISULFATE |
ACME LABS |
Labeling |
Approval |
| 05/20/2020 |
CLOPIDOGREL BISULFATE
ANDA #078004 |
SUPPL-3 |
CLOPIDOGREL BISULFATE |
ACME LABS |
Labeling |
Approval |
| 05/20/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #078228 |
SUPPL-3 |
HYDROMORPHONE HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 05/20/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #078228 |
SUPPL-7 |
HYDROMORPHONE HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 05/20/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #078261 |
SUPPL-4 |
HYDROMORPHONE HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 05/20/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #078261 |
SUPPL-7 |
HYDROMORPHONE HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 05/20/2020 |
SELFEMRA
ANDA #200151 |
SUPPL-4 |
FLUOXETINE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
| 05/20/2020 |
MESALAMINE
ANDA #203574 |
SUPPL-1 |
MESALAMINE |
MYLAN |
Labeling |
Approval |
| 05/20/2020 |
KYBELLA
NDA #206333 |
SUPPL-2 |
DEOXYCHOLIC ACID |
ABBVIE |
Labeling |
Approval |
| 05/20/2020 |
KYBELLA
NDA #206333 |
SUPPL-3 |
DEOXYCHOLIC ACID |
ABBVIE |
Labeling |
Approval |
| 05/20/2020 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #207551 |
ORIG-1 |
DEXMEDETOMIDINE HYDROCHLORIDE |
AMNEAL PHARMS CO |
|
Approval |
| 05/20/2020 |
FINGOLIMOD
ANDA #208559 |
ORIG-1 |
FINGOLIMOD |
MSN LABS PVT LTD |
|
Tentative Approval |
| 05/20/2020 |
OLOPATADINE HYDROCHLORIDE
ANDA #209752 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
GLAND PHARMA LTD |
|
Approval |
| 05/20/2020 |
ENTECAVIR
ANDA #211978 |
ORIG-1 |
ENTECAVIR |
SUNSHINE |
|
Approval |
| 05/20/2020 |
CERIANNA
NDA #212155 |
ORIG-1 |
FLUOROESTRADIOL F-18 |
GE HEALTHCARE |
Type 1 - New Molecular Entity |
Approval |
| 05/20/2020 |
OSELTAMIVIR PHOSPHATE
ANDA #212544 |
ORIG-1 |
OSELTAMIVIR PHOSPHATE |
MSN |
|
Approval |
| 05/20/2020 |
DIHYDROERGOTAMINE MESYLATE
ANDA #212907 |
ORIG-1 |
DIHYDROERGOTAMINE MESYLATE |
CIPLA |
|
Approval |
| 05/20/2020 |
SUCCINYLCHOLINE CHLORIDE
ANDA #213705 |
ORIG-1 |
SUCCINYLCHOLINE CHLORIDE |
ACCORD HLTHCARE |
|
Approval |
| 05/21/2020 |
CRESTOR
NDA #021366 |
SUPPL-40 |
ROSUVASTATIN CALCIUM |
IPR |
Labeling |
Approval |
| 05/21/2020 |
CRESTOR
NDA #021366 |
SUPPL-41 |
ROSUVASTATIN CALCIUM |
IPR |
Labeling |
Approval |
| 05/21/2020 |
ASACOL HD
NDA #021830 |
SUPPL-15 |
MESALAMINE |
ABBVIE |
Manufacturing (CMC) |
Approval |
| 05/21/2020 |
LUMI-SPORYN
NDA #050417 |
SUPPL-12 |
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
CASPER PHARMA LLC |
Labeling |
Approval |
| 05/21/2020 |
DILTIAZEM HYDROCHLORIDE
ANDA #072838 |
SUPPL-24 |
DILTIAZEM HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 05/21/2020 |
CEFEPIME HYDROCHLORIDE
ANDA #091048 |
SUPPL-4 |
CEFEPIME HYDROCHLORIDE |
SAGENT PHARMS INC |
Labeling |
Approval |
| 05/21/2020 |
GUANFACINE HYDROCHLORIDE
ANDA #200881 |
SUPPL-10 |
GUANFACINE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 05/21/2020 |
DUOPA
NDA #203952 |
SUPPL-11 |
CARBIDOPA; LEVODOPA |
ABBVIE |
Labeling |
Approval |
| 05/21/2020 |
DELZICOL
NDA #204412 |
SUPPL-11 |
MESALAMINE |
ABBVIE |
Manufacturing (CMC) |
Approval |
| 05/21/2020 |
DECITABINE
NDA #205582 |
SUPPL-14 |
DECITABINE |
SUN PHARM |
Labeling |
Approval |
| 05/21/2020 |
GUANFACINE HYDROCHLORIDE
ANDA #205689 |
SUPPL-9 |
GUANFACINE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
| 05/21/2020 |
IRINOTECAN HYDROCHLORIDE
ANDA #206935 |
SUPPL-4 |
IRINOTECAN HYDROCHLORIDE |
NOVAST LABS |
Labeling |
Approval |
| 05/21/2020 |
IRINOTECAN HYDROCHLORIDE
ANDA #206935 |
SUPPL-6 |
IRINOTECAN HYDROCHLORIDE |
NOVAST LABS |
Labeling |
Approval |
| 05/21/2020 |
CLONIDINE HYDROCHLORIDE
ANDA #209285 |
SUPPL-1 |
CLONIDINE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 05/21/2020 |
CLONIDINE HYDROCHLORIDE
ANDA #209285 |
SUPPL-3 |
CLONIDINE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 05/21/2020 |
ICOSAPENT ETHYL
ANDA #209457 |
ORIG-1 |
ICOSAPENT ETHYL |
HIKMA |
|
Approval |
| 05/21/2020 |
KYNMOBI
NDA #210875 |
ORIG-1 |
APOMORPHINE HYDROCHLORIDE |
SUMITOMO PHARMA AM |
Type 3 - New Dosage Form |
Approval |
| 05/21/2020 |
CLONIDINE HYDROCHLORIDE
ANDA #211433 |
SUPPL-2 |
CLONIDINE HYDROCHLORIDE |
BLUEPHARMA INDUSTRIA |
Labeling |
Approval |
| 05/21/2020 |
TRIENTINE HYDROCHLORIDE
ANDA #211637 |
ORIG-1 |
TRIENTINE HYDROCHLORIDE |
LUPIN LTD |
|
Approval |
| 05/21/2020 |
AMANTADINE HYDROCHLORIDE
ANDA #212044 |
ORIG-1 |
AMANTADINE HYDROCHLORIDE |
RUBICON |
|
Approval |
| 05/22/2020 |
CALAN SR
NDA #019152 |
SUPPL-45 |
VERAPAMIL HYDROCHLORIDE |
PFIZER |
Manufacturing (CMC) |
Approval |
| 05/22/2020 |
ATNAA
NDA #021175 |
SUPPL-41 |
ATROPINE; PRALIDOXIME CHLORIDE |
US ARMY |
Labeling |
Approval |
| 05/22/2020 |
UROXATRAL
NDA #021287 |
SUPPL-24 |
ALFUZOSIN HYDROCHLORIDE |
CONCORDIA |
Labeling |
Approval |
| 05/22/2020 |
PHEXXI
NDA #208352 |
ORIG-1 |
CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE |
EVOFEM INC |
Type 3 - New Dosage Form and Type 4 - New Combination |
Approval |
| 05/22/2020 |
ALUNBRIG
NDA #208772 |
SUPPL-8 |
BRIGATINIB |
TAKEDA PHARMS USA |
Efficacy |
Approval |
| 05/22/2020 |
PALONOSETRON HYDROCHLORIDE
ANDA #208789 |
ORIG-1 |
PALONOSETRON HYDROCHLORIDE |
NOVAST LABS |
|
Approval |
| 05/22/2020 |
TREPROSTINIL
ANDA #210214 |
ORIG-1 |
TREPROSTINIL |
DR REDDYS |
|
Approval |
| 05/22/2020 |
DICYCLOMINE HYDROCHLORIDE
ANDA #212286 |
ORIG-1 |
DICYCLOMINE HYDROCHLORIDE |
HIKMA |
|
Approval |
| 05/22/2020 |
AMPHETAMINE SULFATE
ANDA #212901 |
ORIG-1 |
AMPHETAMINE SULFATE |
SENORES PHARMS |
|
Approval |
| 05/22/2020 |
SUCCINYLCHOLINE CHLORIDE
ANDA #214308 |
ORIG-1 |
SUCCINYLCHOLINE CHLORIDE |
INDOCO |
|
Approval |
| 05/23/2020 |
TAGRISSO
NDA #208065 |
SUPPL-16 |
OSIMERTINIB MESYLATE |
ASTRAZENECA |
Efficacy |
Approval |
| 05/25/2020 |
CEFEPIME HYDROCHLORIDE
ANDA #065441 |
SUPPL-16 |
CEFEPIME HYDROCHLORIDE |
ACS DOBFAR |
Labeling |
Approval |
| 05/25/2020 |
CEFEPIME HYDROCHLORIDE
ANDA #065441 |
SUPPL-18 |
CEFEPIME HYDROCHLORIDE |
ACS DOBFAR |
Labeling |
Approval |
| 05/25/2020 |
CEFEPIME HYDROCHLORIDE
ANDA #065441 |
SUPPL-19 |
CEFEPIME HYDROCHLORIDE |
ACS DOBFAR |
Labeling |
Approval |
| 05/25/2020 |
CEFEPIME HYDROCHLORIDE
ANDA #065441 |
SUPPL-20 |
CEFEPIME HYDROCHLORIDE |
ACS DOBFAR |
Labeling |
Approval |
| 05/25/2020 |
CEFEPIME HYDROCHLORIDE
ANDA #065441 |
SUPPL-21 |
CEFEPIME HYDROCHLORIDE |
ACS DOBFAR |
Labeling |
Approval |
| 05/25/2020 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #204023 |
SUPPL-2 |
DEXMEDETOMIDINE HYDROCHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 05/25/2020 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #204023 |
SUPPL-7 |
DEXMEDETOMIDINE HYDROCHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 05/25/2020 |
ALBENDAZOLE
ANDA #208979 |
SUPPL-1 |
ALBENDAZOLE |
ZYDUS PHARMS |
Labeling |
Approval |
| 05/25/2020 |
VABOMERE
NDA #209776 |
SUPPL-3 |
MEROPENEM; VABORBACTAM |
REMPEX |
Labeling |
Approval |
| 05/26/2020 |
VESICARE
NDA #021518 |
SUPPL-17 |
SOLIFENACIN SUCCINATE |
ASTELLAS |
Labeling |
Approval |
| 05/26/2020 |
ZOSYN
NDA #050684 |
SUPPL-96 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
WYETH PHARMS |
Efficacy |
Approval |
| 05/26/2020 |
ZOSYN IN PLASTIC CONTAINER
NDA #050750 |
SUPPL-43 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
BAXTER HLTHCARE CORP |
Efficacy |
Approval |
| 05/26/2020 |
AZITHROMYCIN
ANDA #065398 |
SUPPL-16 |
AZITHROMYCIN |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
| 05/26/2020 |
AZITHROMYCIN
ANDA #065399 |
SUPPL-16 |
AZITHROMYCIN |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
| 05/26/2020 |
REBIF
BLA #103780 |
SUPPL-5203 |
INTERFERON BETA-1A |
SERONO INC |
|
Approval |
| 05/26/2020 |
REBIF
BLA #103780 |
SUPPL-5207 |
INTERFERON BETA-1A |
SERONO INC |
|
Approval |
| 05/26/2020 |
YERVOY
BLA #125377 |
SUPPL-110 |
IPILIMUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 05/26/2020 |
OPDIVO
BLA #125554 |
SUPPL-82 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 05/26/2020 |
TINIDAZOLE
ANDA #201172 |
SUPPL-2 |
TINIDAZOLE |
HIKMA |
Labeling |
Approval |
| 05/26/2020 |
TINIDAZOLE
ANDA #202489 |
SUPPL-3 |
TINIDAZOLE |
THINQ PHARM-CRO PVT |
Labeling |
Approval |
| 05/26/2020 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #202881 |
SUPPL-3 |
DEXMEDETOMIDINE HYDROCHLORIDE |
MYLAN INSTITUTIONAL |
Labeling |
Approval |
| 05/26/2020 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #202881 |
SUPPL-7 |
DEXMEDETOMIDINE HYDROCHLORIDE |
MYLAN INSTITUTIONAL |
Labeling |
Approval |
| 05/26/2020 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #202881 |
SUPPL-8 |
DEXMEDETOMIDINE HYDROCHLORIDE |
MYLAN INSTITUTIONAL |
Labeling |
Approval |
| 05/26/2020 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #202881 |
SUPPL-9 |
DEXMEDETOMIDINE HYDROCHLORIDE |
MYLAN INSTITUTIONAL |
Labeling |
Approval |
| 05/26/2020 |
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
ANDA #203460 |
SUPPL-9 |
MIDAZOLAM HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 05/26/2020 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #204686 |
SUPPL-1 |
DEXMEDETOMIDINE HYDROCHLORIDE |
ACTAVIS INC |
Labeling |
Approval |
| 05/26/2020 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #204686 |
SUPPL-3 |
DEXMEDETOMIDINE HYDROCHLORIDE |
ACTAVIS INC |
Labeling |
Approval |
| 05/26/2020 |
CISATRACURIUM BESYLATE PRESERVATIVE FREE
ANDA #206791 |
SUPPL-2 |
CISATRACURIUM BESYLATE |
SOMERSET THERAPS LLC |
Labeling |
Approval |
| 05/26/2020 |
CISATRACURIUM BESYLATE
ANDA #209132 |
SUPPL-2 |
CISATRACURIUM BESYLATE |
SOMERSET |
Labeling |
Approval |
| 05/26/2020 |
VESICARE LS
NDA #209529 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
ASTELLAS |
Type 3 - New Dosage Form |
Approval |
| 05/26/2020 |
CHLORZOXAZONE
ANDA #212185 |
ORIG-1 |
CHLORZOXAZONE |
GLENMARK PHARMS LTD |
|
Approval |
| 05/26/2020 |
ARTESUNATE
NDA #213036 |
ORIG-1 |
ARTESUNATE |
AMIVAS |
Type 1 - New Molecular Entity |
Approval |
| 05/26/2020 |
DUPIXENT
BLA #761055 |
SUPPL-20 |
DUPILUMAB |
REGENERON PHARMACEUTICALS |
|
Approval |
| 05/26/2020 |
RUXIENCE
BLA #761103 |
SUPPL-3 |
RITUXIMAB-PVVR |
PFIZER INC |
|
Approval |
| 05/27/2020 |
BACLOFEN
ANDA #077088 |
SUPPL-2 |
BACLOFEN |
OXFORD PHARMS |
Labeling |
Approval |
| 05/27/2020 |
NICARDIPINE HYDROCHLORIDE
ANDA #090664 |
SUPPL-4 |
NICARDIPINE HYDROCHLORIDE |
RK PHARMA |
Labeling |
Approval |
| 05/27/2020 |
NICARDIPINE HYDROCHLORIDE
ANDA #090664 |
SUPPL-5 |
NICARDIPINE HYDROCHLORIDE |
RK PHARMA |
Labeling |
Approval |
| 05/27/2020 |
CAMPATH
BLA #103948 |
SUPPL-5173 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 05/27/2020 |
LEMTRADA
BLA #103948 |
SUPPL-5173 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 05/27/2020 |
GUANFACINE HYDROCHLORIDE
ANDA #201382 |
SUPPL-7 |
GUANFACINE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
| 05/27/2020 |
CLONIDINE HYDROCHLORIDE
ANDA #203320 |
SUPPL-4 |
CLONIDINE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 05/27/2020 |
CLONIDINE HYDROCHLORIDE
ANDA #203320 |
SUPPL-8 |
CLONIDINE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 05/27/2020 |
SIRTURO
NDA #204384 |
SUPPL-13 |
BEDAQUILINE FUMARATE |
JANSSEN THERAP |
Efficacy |
Approval |
| 05/27/2020 |
ABACAVIR SULFATE AND LAMIVUDINE
ANDA #206151 |
SUPPL-2 |
ABACAVIR SULFATE; LAMIVUDINE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 05/27/2020 |
ABACAVIR SULFATE AND LAMIVUDINE
ANDA #206151 |
SUPPL-5 |
ABACAVIR SULFATE; LAMIVUDINE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 05/27/2020 |
AKYNZEO
NDA #210493 |
SUPPL-2 |
FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE |
HELSINN HLTHCARE |
Manufacturing (CMC) |
Approval |
| 05/27/2020 |
OSELTAMIVIR PHOSPHATE
ANDA #212784 |
ORIG-1 |
OSELTAMIVIR PHOSPHATE |
AJANTA PHARMA LTD |
|
Approval |
| 05/27/2020 |
TIZANIDINE HYDROCHLORIDE
ANDA #213798 |
ORIG-1 |
TIZANIDINE HYDROCHLORIDE |
RUBICON |
|
Approval |
| 05/28/2020 |
QUTENZA
NDA #022395 |
SUPPL-18 |
CAPSAICIN |
AVERITAS |
Labeling |
Approval |
| 05/28/2020 |
BRILINTA
NDA #022433 |
SUPPL-28 |
TICAGRELOR |
ASTRAZENECA |
Efficacy |
Approval |
| 05/28/2020 |
BUSPIRONE HYDROCHLORIDE
ANDA #075388 |
SUPPL-6 |
BUSPIRONE HYDROCHLORIDE |
OXFORD PHARMS |
Labeling |
Approval |
| 05/28/2020 |
BUSPIRONE HYDROCHLORIDE
ANDA #075467 |
SUPPL-21 |
BUSPIRONE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 05/28/2020 |
BUSPIRONE HYDROCHLORIDE
ANDA #075521 |
SUPPL-6 |
BUSPIRONE HYDROCHLORIDE |
RUBICON |
Labeling |
Approval |
| 05/28/2020 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #075727 |
SUPPL-22 |
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE |
COSETTE |
Labeling |
Approval |
| 05/28/2020 |
LISINOPRIL
ANDA #075783 |
SUPPL-18 |
LISINOPRIL |
TEVA |
Labeling |
Approval |
| 05/28/2020 |
LISINOPRIL
ANDA #076164 |
SUPPL-15 |
LISINOPRIL |
PRINSTON INC |
Labeling |
Approval |
| 05/28/2020 |
FUROSEMIDE
ANDA #078010 |
SUPPL-13 |
FUROSEMIDE |
IPCA LABS LTD |
Labeling |
Approval |
| 05/28/2020 |
FUROSEMIDE
ANDA #078010 |
SUPPL-18 |
FUROSEMIDE |
IPCA LABS LTD |
Labeling |
Approval |
| 05/28/2020 |
SIMVASTATIN
ANDA #078103 |
SUPPL-44 |
SIMVASTATIN |
LUPIN |
Labeling |
Approval |
| 05/28/2020 |
BUSPIRONE HYDROCHLORIDE
ANDA #078302 |
SUPPL-2 |
BUSPIRONE HYDROCHLORIDE |
OXFORD PHARMS |
Labeling |
Approval |
| 05/28/2020 |
ACTEMRA
BLA #125276 |
SUPPL-129 |
TOCILIZUMAB |
GENENTECH |
|
Approval |
| 05/28/2020 |
ACTEMRA
BLA #125472 |
SUPPL-42 |
TOCILIZUMAB |
GENENTECH |
|
Approval |
| 05/28/2020 |
DIFICID
NDA #201699 |
SUPPL-13 |
FIDAXOMICIN |
CUBIST PHARMS LLC |
Labeling |
Approval |
| 05/28/2020 |
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #204777 |
ORIG-1 |
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE |
MICRO LABS |
|
Approval |
| 05/28/2020 |
ARIPIPRAZOLE
ANDA #205064 |
SUPPL-1 |
ARIPIPRAZOLE |
HETERO LABS LTD V |
Labeling |
Approval |
| 05/28/2020 |
ARIPIPRAZOLE
ANDA #205064 |
SUPPL-3 |
ARIPIPRAZOLE |
HETERO LABS LTD V |
Labeling |
Approval |
| 05/28/2020 |
ARIPIPRAZOLE
ANDA #205064 |
SUPPL-4 |
ARIPIPRAZOLE |
HETERO LABS LTD V |
Manufacturing (CMC) |
Approval |
| 05/28/2020 |
ARIPIPRAZOLE
ANDA #205064 |
SUPPL-6 |
ARIPIPRAZOLE |
HETERO LABS LTD V |
Labeling |
Approval |
| 05/28/2020 |
ARIPIPRAZOLE
ANDA #205064 |
SUPPL-7 |
ARIPIPRAZOLE |
HETERO LABS LTD V |
Labeling |
Approval |
| 05/28/2020 |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA #208454 |
ORIG-1 |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
SUN PHARM INDS LTD |
|
Tentative Approval |
| 05/28/2020 |
LUTATHERA
NDA #208700 |
SUPPL-10 |
LUTETIUM LU 177 DOTATATE |
AAA USA INC |
Efficacy |
Approval |
| 05/28/2020 |
ESOMEPRAZOLE MAGNESIUM
ANDA #208939 |
ORIG-1 |
ESOMEPRAZOLE MAGNESIUM |
HETERO LABS LTD III |
|
Approval |
| 05/28/2020 |
DAPAGLIFLOZIN AND SAXAGLIPTIN
ANDA #211533 |
ORIG-1 |
DAPAGLIFLOZIN; SAXAGLIPTIN |
MSN LABS PVT LTD |
|
Tentative Approval |
| 05/28/2020 |
TAUVID
NDA #212123 |
ORIG-1 |
FLORTAUCIPIR F-18 |
AVID RADIOPHARMS INC |
Type 1 - New Molecular Entity |
Approval |
| 05/28/2020 |
DIFICID
NDA #213138 |
SUPPL-1 |
FIDAXOMICIN |
CUBIST PHARMS LLC |
Labeling |
Approval |
| 05/28/2020 |
ZILXI
NDA #213690 |
ORIG-1 |
MINOCYCLINE HYDROCHLORIDE |
JOURNEY |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 05/29/2020 |
BUSPIRONE HYDROCHLORIDE
ANDA #074253 |
SUPPL-8 |
BUSPIRONE HYDROCHLORIDE |
IMPAX LABS INC |
Labeling |
Approval |
| 05/29/2020 |
BUSPIRONE HYDROCHLORIDE
ANDA #075022 |
SUPPL-22 |
BUSPIRONE HYDROCHLORIDE |
TEVA |
Labeling |
Approval |
| 05/29/2020 |
BUSPIRONE HYDROCHLORIDE
ANDA #075413 |
SUPPL-1 |
BUSPIRONE HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 05/29/2020 |
LEVOFLOXACIN
ANDA #077652 |
SUPPL-17 |
LEVOFLOXACIN |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
| 05/29/2020 |
BUSPIRONE HYDROCHLORIDE
ANDA #078888 |
SUPPL-4 |
BUSPIRONE HYDROCHLORIDE |
ZYDUS PHARMS |
Labeling |
Approval |
| 05/29/2020 |
CHLOROQUINE PHOSPHATE
ANDA #083082 |
SUPPL-56 |
CHLOROQUINE PHOSPHATE |
HIKMA PHARMS |
Labeling |
Approval |
| 05/29/2020 |
PIPERACILLIN AND TAZOBACTAM
ANDA #090498 |
SUPPL-7 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
ISTITUTO BIO ITA SPA |
Labeling |
Approval |
| 05/29/2020 |
PIPERACILLIN AND TAZOBACTAM
ANDA #090498 |
SUPPL-8 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
ISTITUTO BIO ITA SPA |
Labeling |
Approval |
| 05/29/2020 |
PIPERACILLIN AND TAZOBACTAM
ANDA #090498 |
SUPPL-13 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
ISTITUTO BIO ITA SPA |
Labeling |
Approval |
| 05/29/2020 |
PIPERACILLIN AND TAZOBACTAM
ANDA #090498 |
SUPPL-16 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
ISTITUTO BIO ITA SPA |
Labeling |
Approval |
| 05/29/2020 |
PIPERACILLIN AND TAZOBACTAM
ANDA #090498 |
SUPPL-17 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
ISTITUTO BIO ITA SPA |
Labeling |
Approval |
| 05/29/2020 |
AVASTIN
BLA #125085 |
SUPPL-332 |
BEVACIZUMAB |
GENENTECH |
|
Approval |
| 05/29/2020 |
CYRAMZA
BLA #125477 |
SUPPL-34 |
RAMUCIRUMAB |
ELI LILLY AND CO |
|
Approval |
| 05/29/2020 |
TALTZ
BLA #125521 |
SUPPL-19 |
IXEKIZUMAB |
ELI LILLY AND CO |
|
Approval |
| 05/29/2020 |
OXYCODONE AND ACETAMINOPHEN
ANDA #202142 |
SUPPL-5 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
MIKART |
Manufacturing (CMC) |
Approval |
| 05/29/2020 |
GUANFACINE HYDROCHLORIDE
ANDA #202568 |
SUPPL-4 |
GUANFACINE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 05/29/2020 |
PALIPERIDONE
ANDA #202645 |
SUPPL-5 |
PALIPERIDONE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 05/29/2020 |
PALIPERIDONE
ANDA #202645 |
SUPPL-6 |
PALIPERIDONE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 05/29/2020 |
PALIPERIDONE
ANDA #202645 |
SUPPL-7 |
PALIPERIDONE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 05/29/2020 |
PALIPERIDONE
ANDA #202645 |
SUPPL-8 |
PALIPERIDONE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 05/29/2020 |
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #202894 |
SUPPL-4 |
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE |
GLENMARK PHARMS |
Labeling |
Approval |
| 05/29/2020 |
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #202894 |
SUPPL-7 |
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE |
GLENMARK PHARMS |
Labeling |
Approval |
| 05/29/2020 |
CISATRACURIUM BESYLATE
ANDA #203236 |
SUPPL-1 |
CISATRACURIUM BESYLATE |
HOSPIRA |
Labeling |
Approval |
| 05/29/2020 |
CISATRACURIUM BESYLATE
ANDA #203236 |
SUPPL-2 |
CISATRACURIUM BESYLATE |
HOSPIRA |
Labeling |
Approval |
| 05/29/2020 |
CISATRACURIUM BESYLATE
ANDA #203236 |
SUPPL-6 |
CISATRACURIUM BESYLATE |
HOSPIRA |
Labeling |
Approval |
| 05/29/2020 |
CISATRACURIUM BESYLATE
ANDA #203238 |
SUPPL-1 |
CISATRACURIUM BESYLATE |
HOSPIRA |
Labeling |
Approval |
| 05/29/2020 |
CISATRACURIUM BESYLATE
ANDA #203238 |
SUPPL-2 |
CISATRACURIUM BESYLATE |
HOSPIRA |
Labeling |
Approval |
| 05/29/2020 |
CISATRACURIUM BESYLATE
ANDA #203238 |
SUPPL-5 |
CISATRACURIUM BESYLATE |
HOSPIRA |
Labeling |
Approval |
| 05/29/2020 |
PALIPERIDONE
ANDA #203802 |
SUPPL-5 |
PALIPERIDONE |
RK PHARMA |
Labeling |
Approval |
| 05/29/2020 |
PALIPERIDONE
ANDA #203802 |
SUPPL-6 |
PALIPERIDONE |
RK PHARMA |
Labeling |
Approval |
| 05/29/2020 |
PALIPERIDONE
ANDA #203802 |
SUPPL-9 |
PALIPERIDONE |
RK PHARMA |
Labeling |
Approval |
| 05/29/2020 |
PALIPERIDONE
ANDA #203802 |
SUPPL-11 |
PALIPERIDONE |
RK PHARMA |
Labeling |
Approval |
| 05/29/2020 |
PALIPERIDONE
ANDA #203802 |
SUPPL-13 |
PALIPERIDONE |
RK PHARMA |
Labeling |
Approval |
| 05/29/2020 |
MESALAMINE
ANDA #203817 |
SUPPL-3 |
MESALAMINE |
ACTAVIS LABS FL |
Labeling |
Approval |
| 05/29/2020 |
AMOXICILLIN
ANDA #204030 |
SUPPL-2 |
AMOXICILLIN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 05/29/2020 |
AMOXICILLIN
ANDA #204030 |
SUPPL-3 |
AMOXICILLIN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 05/29/2020 |
AMOXICILLIN
ANDA #204030 |
SUPPL-5 |
AMOXICILLIN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 05/29/2020 |
ENTERO VU 24%
NDA #208143 |
SUPPL-11 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 05/29/2020 |
LIQUID E-Z-PAQUE
NDA #208143 |
SUPPL-11 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 05/29/2020 |
READI-CAT 2
NDA #208143 |
SUPPL-11 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 05/29/2020 |
READI-CAT 2 SMOOTHIE
NDA #208143 |
SUPPL-11 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 05/29/2020 |
TAGITOL V
NDA #208143 |
SUPPL-11 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 05/29/2020 |
VARIBAR HONEY
NDA #208143 |
SUPPL-11 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 05/29/2020 |
VARIBAR NECTAR
NDA #208143 |
SUPPL-11 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 05/29/2020 |
VARIBAR THIN HONEY
NDA #208143 |
SUPPL-11 |
BARIUM SULFATE |
BRACCO |
Efficacy |
Approval |
| 05/29/2020 |
ZEJULA
NDA #208447 |
SUPPL-18 |
NIRAPARIB TOSYLATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 05/29/2020 |
VENCLEXTA
NDA #208573 |
SUPPL-18 |
VENETOCLAX |
ABBVIE |
Labeling |
Approval |
| 05/29/2020 |
LUTATHERA
NDA #208700 |
SUPPL-1 |
LUTETIUM LU 177 DOTATATE |
AAA USA INC |
Efficacy |
Approval |
| 05/29/2020 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #209065 |
SUPPL-6 |
DEXMEDETOMIDINE HYDROCHLORIDE |
HENGRUI PHARMA |
Labeling |
Approval |
| 05/29/2020 |
TYBLUME
NDA #209405 |
SUPPL-1 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
EXELTIS USA INC |
Labeling |
Approval |
| 05/29/2020 |
CLONIDINE HYDROCHLORIDE
ANDA #210052 |
SUPPL-1 |
CLONIDINE HYDROCHLORIDE |
AMNEAL PHARMS NY |
Labeling |
Approval |
| 05/29/2020 |
CLONIDINE HYDROCHLORIDE
ANDA #210680 |
SUPPL-1 |
CLONIDINE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 05/29/2020 |
LORBRENA
NDA #210868 |
SUPPL-1 |
LORLATINIB |
PFIZER |
Labeling |
Approval |
| 05/29/2020 |
SILDENAFIL CITRATE
ANDA #211534 |
ORIG-1 |
SILDENAFIL CITRATE |
TEVA PHARMS USA |
|
Approval |
| 05/29/2020 |
ARTESUNATE
NDA #213170 |
ORIG-1 |
ARTESUNATE |
LA JOLLA PHARMA |
Type 1 - New Molecular Entity |
Tentative Approval |
| 05/29/2020 |
ORIAHNN (COPACKAGED)
NDA #213388 |
ORIG-1 |
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM |
ABBVIE |
Type 4 - New Combination |
Approval |
| 05/29/2020 |
TECENTRIQ
BLA #761034 |
SUPPL-25 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
| 05/29/2020 |
TRUXIMA
BLA #761088 |
SUPPL-9 |
RITUXIMAB-ABBS |
CELLTRION INC |
|
Approval |
| 05/31/2020 |
FUROSEMIDE
ANDA #076796 |
SUPPL-16 |
FUROSEMIDE |
PRINSTON INC |
Labeling |
Approval |
| 05/31/2020 |
FUROSEMIDE
ANDA #076796 |
SUPPL-20 |
FUROSEMIDE |
PRINSTON INC |
Labeling |
Approval |
