| 09/01/2020 |
XALATAN
NDA #020597 |
SUPPL-52 |
LATANOPROST |
UPJOHN |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #062911 |
SUPPL-43 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #062911 |
SUPPL-47 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #062911 |
SUPPL-55 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #062912 |
SUPPL-52 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #062912 |
SUPPL-74 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #062931 |
SUPPL-27 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #062931 |
SUPPL-29 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #062931 |
SUPPL-31 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #062931 |
SUPPL-39 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #062933 |
SUPPL-33 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #062933 |
SUPPL-35 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #062933 |
SUPPL-38 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #062933 |
SUPPL-46 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #063076 |
SUPPL-27 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #063076 |
SUPPL-30 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #063076 |
SUPPL-39 |
VANCOMYCIN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 09/01/2020 |
FENOFIBRATE
ANDA #090715 |
SUPPL-13 |
FENOFIBRATE |
VALEANT PHARMS NORTH |
Labeling |
Approval |
| 09/01/2020 |
COLESEVELAM HYDROCHLORIDE
ANDA #202178 |
ORIG-1 |
COLESEVELAM HYDROCHLORIDE |
WATSON LABS INC |
|
Approval |
| 09/01/2020 |
BARHEMSYS
NDA #209510 |
SUPPL-2 |
AMISULPRIDE |
ACACIA |
Manufacturing (CMC) |
Approval |
| 09/01/2020 |
OMEPRAZOLE
ANDA #210070 |
SUPPL-1 |
OMEPRAZOLE |
APOTEX |
Manufacturing (CMC) |
Approval |
| 09/01/2020 |
ERLEADA
NDA #210951 |
SUPPL-3 |
APALUTAMIDE |
JANSSEN BIOTECH |
Labeling |
Approval |
| 09/01/2020 |
PHENYLEPHRINE HYDROCHLORIDE
ANDA #211079 |
SUPPL-3 |
PHENYLEPHRINE HYDROCHLORIDE |
AMNEAL |
Labeling |
Approval |
| 09/01/2020 |
PHENYLEPHRINE HYDROCHLORIDE
ANDA #211079 |
SUPPL-6 |
PHENYLEPHRINE HYDROCHLORIDE |
AMNEAL |
Labeling |
Approval |
| 09/01/2020 |
APREMILAST
ANDA #211700 |
ORIG-1 |
APREMILAST |
PHARMASCIENCE INC |
|
Tentative Approval |
| 09/01/2020 |
FENTANYL CITRATE
ANDA #212086 |
ORIG-1 |
FENTANYL CITRATE |
FRESENIUS KABI USA |
|
Approval |
| 09/01/2020 |
ITRACONAZOLE
ANDA #212239 |
ORIG-1 |
ITRACONAZOLE |
ANNORA PHARMA |
|
Approval |
| 09/01/2020 |
PIQRAY
NDA #212526 |
SUPPL-1 |
ALPELISIB |
NOVARTIS |
Labeling |
Approval |
| 09/01/2020 |
MIDODRINE HYDROCHLORIDE
ANDA #213055 |
ORIG-1 |
MIDODRINE HYDROCHLORIDE |
ZYDUS LIFESCIENCES |
|
Approval |
| 09/01/2020 |
CISATRACURIUM BESYLATE
ANDA #213527 |
ORIG-1 |
CISATRACURIUM BESYLATE |
ZYDUS PHARMS |
|
Approval |
| 09/01/2020 |
QDOLO
NDA #214044 |
ORIG-1 |
TRAMADOL HYDROCHLORIDE |
ATHENA |
Type 3 - New Dosage Form |
Approval |
| 09/01/2020 |
ONUREG
NDA #214120 |
ORIG-1 |
AZACITIDINE |
BRISTOL |
Type 3 - New Dosage Form |
Approval |
| 09/02/2020 |
CORLOPAM
NDA #019922 |
SUPPL-19 |
FENOLDOPAM MESYLATE |
HOSPIRA |
Labeling |
Approval |
| 09/02/2020 |
RIFAMPIN
ANDA #065390 |
SUPPL-17 |
RIFAMPIN |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 09/02/2020 |
COLESEVELAM HYDROCHLORIDE
ANDA #200830 |
ORIG-1 |
COLESEVELAM HYDROCHLORIDE |
WATSON LABS INC |
|
Approval |
| 09/02/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #200837 |
SUPPL-5 |
VANCOMYCIN HYDROCHLORIDE |
SAGENT PHARMS |
Labeling |
Approval |
| 09/02/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #200837 |
SUPPL-8 |
VANCOMYCIN HYDROCHLORIDE |
SAGENT PHARMS |
Labeling |
Approval |
| 09/02/2020 |
NITYR
NDA #209449 |
SUPPL-5 |
NITISINONE |
CYCLE |
Efficacy |
Approval |
| 09/02/2020 |
NUZYRA
NDA #209816 |
SUPPL-8 |
OMADACYCLINE TOSYLATE |
PARATEK PHARMS INC |
Labeling |
Approval |
| 09/02/2020 |
NUZYRA
NDA #209817 |
SUPPL-7 |
OMADACYCLINE TOSYLATE |
PARATEK PHARMS INC |
Labeling |
Approval |
| 09/02/2020 |
PREDNISONE
ANDA #210785 |
ORIG-1 |
PREDNISONE |
STRIDES PHARMA |
|
Approval |
| 09/02/2020 |
ICATIBANT ACETATE
ANDA #211501 |
ORIG-1 |
ICATIBANT ACETATE |
WILSHIRE PHARMS INC |
|
Approval |
| 09/02/2020 |
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
ANDA #213269 |
ORIG-1 |
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE |
TARO |
|
Approval |
| 09/03/2020 |
GLUCAGEN
NDA #020918 |
SUPPL-53 |
GLUCAGON HYDROCHLORIDE |
NOVO NORDISK |
Labeling |
Approval |
| 09/03/2020 |
TRULICITY
BLA #125469 |
SUPPL-36 |
DULAGLUTIDE |
ELI LILLY AND CO |
|
Approval |
| 09/03/2020 |
FAMCICLOVIR
ANDA #202438 |
SUPPL-1 |
FAMCICLOVIR |
HETERO LABS LTD V |
Labeling |
Approval |
| 09/03/2020 |
FAMCICLOVIR
ANDA #202438 |
SUPPL-3 |
FAMCICLOVIR |
HETERO LABS LTD V |
Labeling |
Approval |
| 09/03/2020 |
TRAVOPROST
ANDA #203431 |
SUPPL-10 |
TRAVOPROST |
APOTEX |
Labeling |
Approval |
| 09/03/2020 |
MILRINONE LACTATE IN DEXTROSE 5%
ANDA #209666 |
ORIG-1 |
MILRINONE LACTATE |
EUGIA PHARMA |
|
Approval |
| 09/03/2020 |
ARIPIPRAZOLE
ANDA #210260 |
ORIG-1 |
ARIPIPRAZOLE |
CADILA PHARMS LTD |
|
Tentative Approval |
| 09/03/2020 |
VANCOMYCIN HYDROCHLORIDE
NDA #211962 |
SUPPL-3 |
VANCOMYCIN HYDROCHLORIDE |
XELLIA PHARMS APS |
Labeling |
Approval |
| 09/03/2020 |
DETECTNET
NDA #213227 |
ORIG-1 |
COPPER CU-64 DOTATATE |
RADIOMEDIX |
Type 1 - New Molecular Entity |
Approval |
| 09/04/2020 |
VFEND
NDA #021266 |
SUPPL-48 |
VORICONAZOLE |
PF PRISM CV |
Labeling |
Approval |
| 09/04/2020 |
VFEND
NDA #021267 |
SUPPL-58 |
VORICONAZOLE |
PF PRISM CV |
Labeling |
Approval |
| 09/04/2020 |
VFEND
NDA #021630 |
SUPPL-37 |
VORICONAZOLE |
PF PRISM CV |
Labeling |
Approval |
| 09/04/2020 |
LOVAZA
NDA #021654 |
SUPPL-44 |
OMEGA-3-ACID ETHYL ESTERS |
WOODWARD |
Labeling |
Approval |
| 09/04/2020 |
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
ANDA #077847 |
SUPPL-5 |
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE |
HIKMA |
Labeling |
Approval |
| 09/04/2020 |
MONTELUKAST SODIUM
ANDA #091414 |
SUPPL-14 |
MONTELUKAST SODIUM |
SANDOZ INC |
Labeling |
Approval |
| 09/04/2020 |
MONTELUKAST SODIUM
ANDA #091414 |
SUPPL-16 |
MONTELUKAST SODIUM |
SANDOZ INC |
Labeling |
Approval |
| 09/04/2020 |
MONTELUKAST SODIUM
ANDA #200889 |
SUPPL-12 |
MONTELUKAST SODIUM |
SANDOZ INC |
Labeling |
Approval |
| 09/04/2020 |
MONTELUKAST SODIUM
ANDA #200889 |
SUPPL-13 |
MONTELUKAST SODIUM |
SANDOZ INC |
Labeling |
Approval |
| 09/04/2020 |
DUTASTERIDE
ANDA #200899 |
SUPPL-2 |
DUTASTERIDE |
CHARTWELL |
Labeling |
Approval |
| 09/04/2020 |
DUTASTERIDE
ANDA #202204 |
SUPPL-1 |
DUTASTERIDE |
HIKMA |
Labeling |
Approval |
| 09/04/2020 |
DOCETAXEL
ANDA #203170 |
SUPPL-8 |
DOCETAXEL |
HENGRUI PHARMA |
Labeling |
Approval |
| 09/04/2020 |
DOCETAXEL
ANDA #203170 |
SUPPL-9 |
DOCETAXEL |
HENGRUI PHARMA |
Labeling |
Approval |
| 09/04/2020 |
ALFUZOSIN HYDROCHLORIDE
ANDA #203192 |
SUPPL-7 |
ALFUZOSIN HYDROCHLORIDE |
UNICHEM |
Labeling |
Approval |
| 09/04/2020 |
RIZATRIPTAN BENZOATE
ANDA #203478 |
SUPPL-1 |
RIZATRIPTAN BENZOATE |
NATCO PHARMA LTD |
Labeling |
Approval |
| 09/04/2020 |
RIZATRIPTAN BENZOATE
ANDA #203478 |
SUPPL-2 |
RIZATRIPTAN BENZOATE |
NATCO PHARMA LTD |
Labeling |
Approval |
| 09/04/2020 |
ACETYLCYSTEINE
ANDA #203624 |
SUPPL-4 |
ACETYLCYSTEINE |
RISING |
Labeling |
Approval |
| 09/04/2020 |
OXALIPLATIN
ANDA #203869 |
SUPPL-6 |
OXALIPLATIN |
HENGRUI PHARMA |
Labeling |
Approval |
| 09/04/2020 |
MONTELUKAST SODIUM
ANDA #205107 |
ORIG-1 |
MONTELUKAST SODIUM |
AMNEAL PHARMS |
|
Approval |
| 09/04/2020 |
NILUTAMIDE
ANDA #207631 |
SUPPL-1 |
NILUTAMIDE |
ANI PHARMS |
Labeling |
Approval |
| 09/04/2020 |
DOXEPIN HYDROCHLORIDE
ANDA #210268 |
ORIG-1 |
DOXEPIN HYDROCHLORIDE |
CHARTWELL RX |
|
Approval |
| 09/04/2020 |
GAVRETO
NDA #213721 |
ORIG-1 |
PRALSETINIB |
RIGEL PHARMS |
Type 1 - New Molecular Entity |
Approval |
| 09/04/2020 |
GAVRETO
NDA #213721 |
SUPPL-1 |
PRALSETINIB |
RIGEL PHARMS |
Type 1 - New Molecular Entity |
Approval |
| 09/08/2020 |
DIFLUCAN
NDA #019949 |
SUPPL-69 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
| 09/08/2020 |
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #019950 |
SUPPL-68 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
| 09/08/2020 |
DIFLUCAN IN SODIUM CHLORIDE 0.9%
NDA #019950 |
SUPPL-68 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
| 09/08/2020 |
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019950 |
SUPPL-68 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
| 09/08/2020 |
DIFLUCAN
NDA #020090 |
SUPPL-50 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
| 09/08/2020 |
DOXYCYCLINE HYCLATE
ANDA #062269 |
SUPPL-29 |
DOXYCYCLINE HYCLATE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 09/08/2020 |
DOXYCYCLINE HYCLATE
ANDA #062269 |
SUPPL-31 |
DOXYCYCLINE HYCLATE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 09/08/2020 |
DOXYCYCLINE HYCLATE
ANDA #062269 |
SUPPL-38 |
DOXYCYCLINE HYCLATE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 09/08/2020 |
DOXYCYCLINE HYCLATE
ANDA #062269 |
SUPPL-41 |
DOXYCYCLINE HYCLATE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 09/08/2020 |
DOXYCYCLINE HYCLATE
ANDA #062269 |
SUPPL-43 |
DOXYCYCLINE HYCLATE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 09/08/2020 |
GABAPENTIN
ANDA #090158 |
SUPPL-5 |
GABAPENTIN |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
| 09/08/2020 |
GABAPENTIN
ANDA #090158 |
SUPPL-6 |
GABAPENTIN |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
| 09/08/2020 |
GABAPENTIN
ANDA #090158 |
SUPPL-8 |
GABAPENTIN |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
| 09/08/2020 |
GABAPENTIN
ANDA #090158 |
SUPPL-9 |
GABAPENTIN |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
| 09/08/2020 |
GABAPENTIN
ANDA #090158 |
SUPPL-10 |
GABAPENTIN |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
| 09/08/2020 |
GABAPENTIN
ANDA #090705 |
SUPPL-17 |
GABAPENTIN |
INVAGEN PHARMS |
Labeling |
Approval |
| 09/08/2020 |
GABAPENTIN
ANDA #090705 |
SUPPL-18 |
GABAPENTIN |
INVAGEN PHARMS |
Labeling |
Approval |
| 09/08/2020 |
GABAPENTIN
ANDA #090705 |
SUPPL-27 |
GABAPENTIN |
INVAGEN PHARMS |
Labeling |
Approval |
| 09/08/2020 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #091431 |
SUPPL-4 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
HERITAGE |
Labeling |
Approval |
| 09/08/2020 |
PIOGLITAZONE HYDROCHLORIDE
ANDA #200044 |
SUPPL-3 |
PIOGLITAZONE HYDROCHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 09/08/2020 |
PIOGLITAZONE HYDROCHLORIDE
ANDA #200044 |
SUPPL-6 |
PIOGLITAZONE HYDROCHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 09/08/2020 |
LINEZOLID
ANDA #200068 |
SUPPL-2 |
LINEZOLID |
HIKMA |
Labeling |
Approval |
| 09/08/2020 |
LINEZOLID
ANDA #200068 |
SUPPL-3 |
LINEZOLID |
HIKMA |
Labeling |
Approval |
| 09/08/2020 |
LINEZOLID
ANDA #200068 |
SUPPL-6 |
LINEZOLID |
HIKMA |
Labeling |
Approval |
| 09/08/2020 |
BIMATOPROST
ANDA #202505 |
ORIG-1 |
BIMATOPROST |
MICRO LABS |
|
Approval |
| 09/08/2020 |
FOSAPREPITANT DIMEGLUMINE
ANDA #213106 |
ORIG-1 |
FOSAPREPITANT DIMEGLUMINE |
QILU PHARM HAINAN |
|
Approval |
| 09/08/2020 |
EMPAGLIFLOZIN; LINAGLIPTIN
ANDA #213345 |
ORIG-1 |
EMPAGLIFLOZIN;LINAGLIPTIN |
ZYDUS PHARMS USA INC |
|
Tentative Approval |
| 09/09/2020 |
DEPO-PROVERA
NDA #020246 |
SUPPL-43 |
MEDROXYPROGESTERONE ACETATE |
PFIZER |
Labeling |
Approval |
| 09/09/2020 |
DEPO-PROVERA
NDA #020246 |
SUPPL-57 |
MEDROXYPROGESTERONE ACETATE |
PFIZER |
Labeling |
Approval |
| 09/09/2020 |
NIASPAN
NDA #020381 |
SUPPL-54 |
NIACIN |
ABBVIE |
Labeling |
Approval |
| 09/09/2020 |
NIASPAN TITRATION STARTER PACK
NDA #020381 |
SUPPL-54 |
NIACIN |
ABBVIE |
Labeling |
Approval |
| 09/09/2020 |
NASONEX
NDA #020762 |
SUPPL-55 |
MOMETASONE FUROATE |
ORGANON LLC |
Labeling |
Approval |
| 09/09/2020 |
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
NDA #050796 |
SUPPL-23 |
CEFTRIAXONE SODIUM |
B BRAUN |
Labeling |
Approval |
| 09/09/2020 |
LOPERAMIDE HYDROCHLORIDE
ANDA #074091 |
SUPPL-36 |
LOPERAMIDE HYDROCHLORIDE |
OHM LABS |
Labeling |
Approval |
| 09/09/2020 |
FAMOTIDINE PRESERVATIVE FREE
ANDA #075622 |
SUPPL-13 |
FAMOTIDINE |
SAGENT |
Manufacturing (CMC) |
Approval |
| 09/09/2020 |
FAMOTIDINE PRESERVATIVE FREE
ANDA #075622 |
SUPPL-14 |
FAMOTIDINE |
SAGENT |
Labeling |
Approval |
| 09/09/2020 |
FAMOTIDINE
ANDA #075651 |
SUPPL-15 |
FAMOTIDINE |
SAGENT |
Labeling |
Approval |
| 09/09/2020 |
RILUZOLE
ANDA #091417 |
SUPPL-3 |
RILUZOLE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 09/09/2020 |
RILUZOLE
ANDA #091417 |
SUPPL-11 |
RILUZOLE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 09/09/2020 |
LITHIUM CARBONATE
ANDA #091544 |
SUPPL-4 |
LITHIUM CARBONATE |
GLENMARK PHARMS INC |
Labeling |
Approval |
| 09/09/2020 |
LITHIUM CARBONATE
ANDA #091544 |
SUPPL-6 |
LITHIUM CARBONATE |
GLENMARK PHARMS INC |
Labeling |
Approval |
| 09/09/2020 |
LITHIUM CARBONATE
ANDA #091544 |
SUPPL-7 |
LITHIUM CARBONATE |
GLENMARK PHARMS INC |
Labeling |
Approval |
| 09/09/2020 |
LITHIUM CARBONATE
ANDA #091544 |
SUPPL-8 |
LITHIUM CARBONATE |
GLENMARK PHARMS INC |
Labeling |
Approval |
| 09/09/2020 |
LITHIUM CARBONATE
ANDA #091544 |
SUPPL-9 |
LITHIUM CARBONATE |
GLENMARK PHARMS INC |
Labeling |
Approval |
| 09/09/2020 |
ZIPRASIDONE HYDROCHLORIDE
ANDA #204375 |
SUPPL-2 |
ZIPRASIDONE HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 09/09/2020 |
ZIPRASIDONE HYDROCHLORIDE
ANDA #204375 |
SUPPL-8 |
ZIPRASIDONE HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 09/09/2020 |
ZIPRASIDONE HYDROCHLORIDE
ANDA #204375 |
SUPPL-14 |
ZIPRASIDONE HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 09/09/2020 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #205272 |
SUPPL-1 |
DEXMEDETOMIDINE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
| 09/09/2020 |
DAPTOMYCIN
ANDA #206005 |
SUPPL-17 |
DAPTOMYCIN |
XELLIA PHARMS APS |
Labeling |
Approval |
| 09/09/2020 |
DAPTOMYCIN
ANDA #206005 |
SUPPL-19 |
DAPTOMYCIN |
XELLIA PHARMS APS |
Labeling |
Approval |
| 09/09/2020 |
SAPROPTERIN DIHYDROCHLORIDE
ANDA #207200 |
SUPPL-2 |
SAPROPTERIN DIHYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 09/09/2020 |
SAPROPTERIN DIHYDROCHLORIDE
ANDA #207207 |
SUPPL-1 |
SAPROPTERIN DIHYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 09/09/2020 |
SAPROPTERIN DIHYDROCHLORIDE
ANDA #207207 |
SUPPL-2 |
SAPROPTERIN DIHYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 09/09/2020 |
TRELEGY ELLIPTA
NDA #209482 |
SUPPL-10 |
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE |
GLAXOSMITHKLINE |
Efficacy |
Approval |
| 09/09/2020 |
TRELEGY ELLIPTA
NDA #209482 |
SUPPL-11 |
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 09/09/2020 |
SAPROPTERIN DIHYDROCHLORIDE
ANDA #210027 |
SUPPL-1 |
SAPROPTERIN DIHYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 09/09/2020 |
SAPROPTERIN DIHYDROCHLORIDE
ANDA #210027 |
SUPPL-2 |
SAPROPTERIN DIHYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 09/09/2020 |
POTASSIUM CHLORIDE 10MEQ
ANDA #211087 |
ORIG-1 |
POTASSIUM CHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 09/09/2020 |
POTASSIUM CHLORIDE 20MEQ
ANDA #211087 |
ORIG-1 |
POTASSIUM CHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 09/09/2020 |
POTASSIUM CHLORIDE 40MEQ
ANDA #211087 |
ORIG-1 |
POTASSIUM CHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 09/09/2020 |
AMMONIA N 13
ANDA #211740 |
ORIG-1 |
AMMONIA N-13 |
UNIV WISCONSIN |
|
Approval |
| 09/09/2020 |
CYANOCOBALAMIN
ANDA #212458 |
ORIG-1 |
CYANOCOBALAMIN |
PADAGIS ISRAEL |
|
Approval |
| 09/09/2020 |
ALOSETRON HYDROCHLORIDE
ANDA #213614 |
ORIG-1 |
ALOSETRON HYDROCHLORIDE |
MANKIND PHARMA |
|
Approval |
| 09/09/2020 |
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #213813 |
ORIG-1 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
GRANULES |
|
Approval |
| 09/10/2020 |
DIGOXIN
ANDA #040282 |
SUPPL-23 |
DIGOXIN |
RISING |
Labeling |
Approval |
| 09/10/2020 |
VALACYCLOVIR HYDROCHLORIDE
ANDA #078656 |
SUPPL-3 |
VALACYCLOVIR HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
| 09/10/2020 |
LEVETIRACETAM
ANDA #091261 |
SUPPL-5 |
LEVETIRACETAM |
APOTEX INC |
Labeling |
Approval |
| 09/10/2020 |
LEVETIRACETAM
ANDA #091261 |
SUPPL-7 |
LEVETIRACETAM |
APOTEX INC |
Labeling |
Approval |
| 09/10/2020 |
LEVETIRACETAM
ANDA #091261 |
SUPPL-9 |
LEVETIRACETAM |
APOTEX INC |
Labeling |
Approval |
| 09/10/2020 |
LEVETIRACETAM
ANDA #091261 |
SUPPL-10 |
LEVETIRACETAM |
APOTEX INC |
Labeling |
Approval |
| 09/10/2020 |
LEVETIRACETAM
ANDA #091261 |
SUPPL-11 |
LEVETIRACETAM |
APOTEX INC |
Labeling |
Approval |
| 09/10/2020 |
LEVETIRACETAM
ANDA #091261 |
SUPPL-14 |
LEVETIRACETAM |
APOTEX INC |
Labeling |
Approval |
| 09/10/2020 |
LEVETIRACETAM
ANDA #202958 |
SUPPL-1 |
LEVETIRACETAM |
APOTEX |
Labeling |
Approval |
| 09/10/2020 |
LEVETIRACETAM
ANDA #202958 |
SUPPL-2 |
LEVETIRACETAM |
APOTEX |
Labeling |
Approval |
| 09/10/2020 |
LEVETIRACETAM
ANDA #202958 |
SUPPL-3 |
LEVETIRACETAM |
APOTEX |
Labeling |
Approval |
| 09/10/2020 |
LEVETIRACETAM
ANDA #202958 |
SUPPL-4 |
LEVETIRACETAM |
APOTEX |
Labeling |
Approval |
| 09/10/2020 |
LEVETIRACETAM
ANDA #202958 |
SUPPL-5 |
LEVETIRACETAM |
APOTEX |
Labeling |
Approval |
| 09/10/2020 |
LEVETIRACETAM
ANDA #202958 |
SUPPL-6 |
LEVETIRACETAM |
APOTEX |
Labeling |
Approval |
| 09/10/2020 |
DECITABINE
ANDA #203131 |
SUPPL-8 |
DECITABINE |
DR REDDYS |
Labeling |
Approval |
| 09/10/2020 |
DECITABINE
ANDA #203131 |
SUPPL-9 |
DECITABINE |
DR REDDYS |
Labeling |
Approval |
| 09/10/2020 |
DALFAMPRIDINE
ANDA #206836 |
SUPPL-1 |
DALFAMPRIDINE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 09/10/2020 |
SORAFENIB TOSYLATE
ANDA #207012 |
ORIG-1 |
SORAFENIB TOSYLATE |
MYLAN |
|
Approval |
| 09/10/2020 |
NINLARO
NDA #208462 |
SUPPL-7 |
IXAZOMIB CITRATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 09/10/2020 |
NINLARO
NDA #208462 |
SUPPL-8 |
IXAZOMIB CITRATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 09/10/2020 |
DOCETAXEL
ANDA #210072 |
SUPPL-5 |
DOCETAXEL |
MYLAN LABS LTD |
Labeling |
Approval |
| 09/10/2020 |
DOCETAXEL
ANDA #210848 |
SUPPL-4 |
DOCETAXEL |
MYLAN LABS LTD |
Labeling |
Approval |
| 09/10/2020 |
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
ANDA #212299 |
ORIG-1 |
DOXORUBICIN HYDROCHLORIDE |
ZYDUS LIFESCIENCES |
|
Approval |
| 09/10/2020 |
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%
ANDA #212346 |
ORIG-1 |
DEXTROSE; POTASSIUM CHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 09/10/2020 |
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%
ANDA #212346 |
ORIG-1 |
DEXTROSE; POTASSIUM CHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 09/10/2020 |
ZAFIRLUKAST
ANDA #212475 |
ORIG-1 |
ZAFIRLUKAST |
ANNORA PHARMA |
|
Approval |
| 09/10/2020 |
LORATADINE
ANDA #214280 |
ORIG-1 |
LORATADINE |
RUBICON |
|
Approval |
| 09/11/2020 |
INFED
NDA #017441 |
SUPPL-178 |
FERRIC OXYHYDROXIDE |
ALLERGAN |
Labeling |
Approval |
| 09/11/2020 |
PREVACID
NDA #020406 |
SUPPL-90 |
LANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 09/11/2020 |
VENOFER
NDA #021135 |
SUPPL-36 |
FERRIC OXYHYDROXIDE |
AM REGENT |
Labeling |
Approval |
| 09/11/2020 |
PREVACID
NDA #021428 |
SUPPL-37 |
LANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 09/11/2020 |
FERAHEME
NDA #022180 |
SUPPL-24 |
FERUMOXYTOL |
COVIS |
Labeling |
Approval |
| 09/11/2020 |
DEXILANT
NDA #022287 |
SUPPL-31 |
DEXLANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 09/11/2020 |
CEFTRIAXONE
ANDA #065180 |
SUPPL-9 |
CEFTRIAXONE SODIUM |
WOCKHARDT |
Labeling |
Approval |
| 09/11/2020 |
CEFTRIAXONE
ANDA #065180 |
SUPPL-10 |
CEFTRIAXONE SODIUM |
WOCKHARDT |
Labeling |
Approval |
| 09/11/2020 |
CEFTRIAXONE
ANDA #065204 |
SUPPL-26 |
CEFTRIAXONE SODIUM |
SANDOZ INC |
Labeling |
Approval |
| 09/11/2020 |
CEFTRIAXONE
ANDA #065342 |
SUPPL-14 |
CEFTRIAXONE SODIUM |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 09/11/2020 |
CEFTRIAXONE
ANDA #065342 |
SUPPL-15 |
CEFTRIAXONE SODIUM |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 09/11/2020 |
CEFTRIAXONE
ANDA #065391 |
SUPPL-10 |
CEFTRIAXONE SODIUM |
WOCKHARDT |
Labeling |
Approval |
| 09/11/2020 |
CEFTRIAXONE
ANDA #065391 |
SUPPL-11 |
CEFTRIAXONE SODIUM |
WOCKHARDT |
Labeling |
Approval |
| 09/11/2020 |
LITHIUM CARBONATE
ANDA #076795 |
SUPPL-11 |
LITHIUM CARBONATE |
APOTEX INC |
Labeling |
Approval |
| 09/11/2020 |
LITHIUM CARBONATE
ANDA #076795 |
SUPPL-12 |
LITHIUM CARBONATE |
APOTEX INC |
Labeling |
Approval |
| 09/11/2020 |
LITHIUM CARBONATE
ANDA #076795 |
SUPPL-14 |
LITHIUM CARBONATE |
APOTEX INC |
Labeling |
Approval |
| 09/11/2020 |
LITHIUM CARBONATE
ANDA #079139 |
SUPPL-8 |
LITHIUM CARBONATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 09/11/2020 |
LITHIUM CARBONATE
ANDA #079139 |
SUPPL-9 |
LITHIUM CARBONATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 09/11/2020 |
LITHIUM CARBONATE
ANDA #079159 |
SUPPL-2 |
LITHIUM CARBONATE |
ALEMBIC LTD |
Labeling |
Approval |
| 09/11/2020 |
LITHIUM CARBONATE
ANDA #079159 |
SUPPL-5 |
LITHIUM CARBONATE |
ALEMBIC LTD |
Labeling |
Approval |
| 09/11/2020 |
LITHIUM CARBONATE
ANDA #079159 |
SUPPL-8 |
LITHIUM CARBONATE |
ALEMBIC LTD |
Labeling |
Approval |
| 09/11/2020 |
INJECTAFER
NDA #203565 |
SUPPL-13 |
FERRIC CARBOXYMALTOSE |
AM REGENT |
Labeling |
Approval |
| 09/11/2020 |
OXYCODONE HYDROCHLORIDE
ANDA #204979 |
SUPPL-2 |
OXYCODONE HYDROCHLORIDE |
ANI PHARMS |
Labeling |
Approval |
| 09/11/2020 |
OXYCODONE HYDROCHLORIDE
ANDA #204979 |
SUPPL-7 |
OXYCODONE HYDROCHLORIDE |
ANI PHARMS |
Labeling |
Approval |
| 09/11/2020 |
OXYCODONE HYDROCHLORIDE
ANDA #204979 |
SUPPL-8 |
OXYCODONE HYDROCHLORIDE |
ANI PHARMS |
Manufacturing (CMC) |
Approval |
| 09/11/2020 |
ILOPERIDONE
ANDA #207231 |
SUPPL-2 |
ILOPERIDONE |
INVENTIA |
Labeling |
Approval |
| 09/11/2020 |
MONOFERRIC
NDA #208171 |
SUPPL-1 |
FERRIC DERISOMALTOSE |
PHARMACOSMOS |
Labeling |
Approval |
| 09/11/2020 |
ICOSAPENT ETHYL
ANDA #209525 |
ORIG-1 |
ICOSAPENT ETHYL |
TEVA PHARMS USA |
|
Approval |
| 09/11/2020 |
APIXABAN
ANDA #209898 |
ORIG-1 |
APIXABAN |
INDOCO |
|
Approval |
| 09/11/2020 |
TIMOLOL MALEATE
ANDA #212291 |
ORIG-1 |
TIMOLOL MALEATE |
EPIC PHARMA LLC |
|
Approval |
| 09/11/2020 |
CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE
ANDA #212367 |
ORIG-1 |
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE |
PADAGIS ISRAEL |
|
Approval |
| 09/11/2020 |
CETIRIZINE HYDROCHLORIDE
ANDA #213557 |
ORIG-1 |
CETIRIZINE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
|
Approval |
| 09/13/2020 |
BOTOX
BLA #103000 |
SUPPL-5317 |
OnabotulinumtoxinA |
ALLERGAN |
|
Approval |
| 09/13/2020 |
BOTOX COSMETIC
BLA #103000 |
SUPPL-5317 |
OnabotulinumtoxinA |
ALLERGAN |
|
Approval |
| 09/14/2020 |
LENVIMA
NDA #206947 |
SUPPL-17 |
LENVATINIB MESYLATE |
EISAI INC |
Labeling |
Approval |
| 09/14/2020 |
BUPROPION HYDROCHLORIDE
ANDA #207459 |
SUPPL-1 |
BUPROPION HYDROCHLORIDE |
JUBILANT GENERICS |
Labeling |
Approval |
| 09/14/2020 |
BUPROPION HYDROCHLORIDE
ANDA #207459 |
SUPPL-5 |
BUPROPION HYDROCHLORIDE |
JUBILANT GENERICS |
Labeling |
Approval |
| 09/14/2020 |
DEXTROSE 5% AND SODIUM CHLORIDE 0.9%
ANDA #211211 |
ORIG-1 |
DEXTROSE; SODIUM CHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 09/14/2020 |
CHLORZOXAZONE
ANDA #212053 |
ORIG-1 |
CHLORZOXAZONE |
CHARTWELL RX |
|
Approval |
| 09/14/2020 |
ACYCLOVIR
ANDA #212173 |
ORIG-1 |
ACYCLOVIR |
YILING |
|
Approval |
| 09/15/2020 |
ADCIRCA
NDA #022332 |
SUPPL-11 |
TADALAFIL |
ELI LILLY CO |
Labeling |
Approval |
| 09/15/2020 |
BRILINTA
NDA #022433 |
SUPPL-30 |
TICAGRELOR |
ASTRAZENECA |
Labeling |
Approval |
| 09/15/2020 |
FAMOTIDINE
ANDA #075709 |
SUPPL-10 |
FAMOTIDINE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 09/15/2020 |
FAMOTIDINE PRESERVATIVE FREE
ANDA #075813 |
SUPPL-11 |
FAMOTIDINE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 09/15/2020 |
BUTORPHANOL TARTRATE
ANDA #078247 |
SUPPL-5 |
BUTORPHANOL TARTRATE |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 09/15/2020 |
BUTORPHANOL TARTRATE
ANDA #078400 |
SUPPL-5 |
BUTORPHANOL TARTRATE |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 09/15/2020 |
FAMOTIDINE
ANDA #078641 |
SUPPL-12 |
FAMOTIDINE |
MYLAN LABS LTD |
Labeling |
Approval |
| 09/15/2020 |
FAMOTIDINE PRESERVATIVE FREE
ANDA #078642 |
SUPPL-8 |
FAMOTIDINE |
MYLAN LABS LTD |
Labeling |
Approval |
| 09/15/2020 |
FLUVASTATIN SODIUM
ANDA #090595 |
SUPPL-3 |
FLUVASTATIN SODIUM |
MYLAN PHARMS INC |
Labeling |
Approval |
| 09/15/2020 |
GLIMEPIRIDE
ANDA #091220 |
SUPPL-15 |
GLIMEPIRIDE |
MICRO LABS |
Labeling |
Approval |
| 09/15/2020 |
OLANZAPINE
ANDA #200221 |
SUPPL-7 |
OLANZAPINE |
JUBILANT GENERICS |
Labeling |
Approval |
| 09/15/2020 |
OLANZAPINE
ANDA #200221 |
SUPPL-8 |
OLANZAPINE |
JUBILANT GENERICS |
Labeling |
Approval |
| 09/15/2020 |
OLANZAPINE
ANDA #200221 |
SUPPL-9 |
OLANZAPINE |
JUBILANT GENERICS |
Labeling |
Approval |
| 09/15/2020 |
OLANZAPINE
ANDA #200221 |
SUPPL-16 |
OLANZAPINE |
JUBILANT GENERICS |
Labeling |
Approval |
| 09/15/2020 |
DOXERCALCIFEROL
ANDA #205360 |
ORIG-1 |
DOXERCALCIFEROL |
AVET |
|
Approval |
| 09/15/2020 |
DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #208266 |
ORIG-1 |
DEXMEDETOMIDINE HYDROCHLORIDE |
ENDO OPERATIONS |
|
Approval |
| 09/15/2020 |
ZIPRASIDONE HYDROCHLORIDE
ANDA #208988 |
SUPPL-1 |
ZIPRASIDONE HYDROCHLORIDE |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
| 09/15/2020 |
ZIPRASIDONE HYDROCHLORIDE
ANDA #208988 |
SUPPL-2 |
ZIPRASIDONE HYDROCHLORIDE |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
| 09/15/2020 |
DEXTROSE 5% AND SODIUM CHLORIDE 0.225%
ANDA #211221 |
ORIG-1 |
DEXTROSE; SODIUM CHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 09/15/2020 |
DEXTROSE 5% AND SODIUM CHLORIDE 0.45%
ANDA #211276 |
ORIG-1 |
DEXTROSE; SODIUM CHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 09/15/2020 |
COLCHICINE
ANDA #211519 |
SUPPL-2 |
COLCHICINE |
ZYDUS PHARMS |
Labeling |
Approval |
| 09/15/2020 |
LISINOPRIL
ANDA #212041 |
ORIG-1 |
LISINOPRIL |
SCIEGEN PHARMS INC |
|
Approval |
| 09/16/2020 |
NOXAFIL
NDA #022003 |
SUPPL-26 |
POSACONAZOLE |
SCHERING |
Labeling |
Approval |
| 09/16/2020 |
NOXAFIL
NDA #205053 |
SUPPL-10 |
POSACONAZOLE |
MERCK SHARP DOHME |
Labeling |
Approval |
| 09/16/2020 |
PROPOFOL
ANDA #205576 |
ORIG-1 |
PROPOFOL |
INNOPHARMA |
|
Approval |
| 09/16/2020 |
DECITABINE
NDA #205582 |
SUPPL-15 |
DECITABINE |
SUN PHARM |
Labeling |
Approval |
| 09/16/2020 |
NOXAFIL
NDA #205596 |
SUPPL-10 |
POSACONAZOLE |
MERCK SHARP DOHME |
Labeling |
Approval |
| 09/16/2020 |
ENVARSUS XR
NDA #206406 |
SUPPL-8 |
TACROLIMUS |
VELOXIS PHARMS INC |
Labeling |
Approval |
| 09/16/2020 |
GABAPENTIN
ANDA #206943 |
SUPPL-1 |
GABAPENTIN |
STRIDES PHARMA |
Labeling |
Approval |
| 09/16/2020 |
GABAPENTIN
ANDA #206943 |
SUPPL-4 |
GABAPENTIN |
STRIDES PHARMA |
Labeling |
Approval |
| 09/16/2020 |
FLECAINIDE ACETATE
ANDA #210683 |
ORIG-1 |
FLECAINIDE ACETATE |
BEXIMCO PHARMS USA |
|
Approval |
| 09/17/2020 |
LISINOPRIL
ANDA #203508 |
SUPPL-6 |
LISINOPRIL |
INVAGEN PHARMS |
Labeling |
Approval |
| 09/17/2020 |
LISINOPRIL
ANDA #203508 |
SUPPL-15 |
LISINOPRIL |
INVAGEN PHARMS |
Labeling |
Approval |
| 09/17/2020 |
BIVALIRUDIN
ANDA #204876 |
SUPPL-1 |
BIVALIRUDIN |
APOTEX |
Labeling |
Approval |
| 09/17/2020 |
BIVALIRUDIN
ANDA #204876 |
SUPPL-2 |
BIVALIRUDIN |
APOTEX |
Labeling |
Approval |
| 09/17/2020 |
BUDESONIDE
ANDA #208851 |
ORIG-1 |
BUDESONIDE |
MYLAN |
|
Approval |
| 09/17/2020 |
DESMOPRESSIN ACETATE
ANDA #210223 |
ORIG-1 |
DESMOPRESSIN ACETATE |
UBI |
|
Approval |
| 09/17/2020 |
YONSA
NDA #210308 |
SUPPL-1 |
ABIRATERONE ACETATE |
SUN PHARM |
Labeling |
Approval |
| 09/17/2020 |
POTASSIUM CHLORIDE
ANDA #210395 |
ORIG-1 |
POTASSIUM CHLORIDE |
ZYDUS PHARMS |
|
Approval |
| 09/17/2020 |
ERYTHROMYCIN LACTOBIONATE
ANDA #211086 |
ORIG-1 |
ERYTHROMYCIN LACTOBIONATE |
EXELA PHARMA |
|
Approval |
| 09/17/2020 |
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%
ANDA #212347 |
ORIG-1 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 09/17/2020 |
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%
ANDA #212347 |
ORIG-1 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 09/17/2020 |
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%
ANDA #212347 |
ORIG-1 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
FRESENIUS KABI USA |
|
Approval |
| 09/18/2020 |
SEROQUEL
NDA #020639 |
SUPPL-70 |
QUETIAPINE FUMARATE |
ASTRAZENECA |
Labeling |
Approval |
| 09/18/2020 |
INVIRASE
NDA #021785 |
SUPPL-25 |
SAQUINAVIR MESYLATE |
HOFFMANN-LA ROCHE |
Labeling |
Approval |
| 09/18/2020 |
SEROQUEL XR
NDA #022047 |
SUPPL-41 |
QUETIAPINE FUMARATE |
ASTRAZENECA |
Labeling |
Approval |
| 09/18/2020 |
SEROQUEL XR
NDA #022047 |
SUPPL-44 |
QUETIAPINE FUMARATE |
ASTRAZENECA |
Labeling |
Approval |
| 09/18/2020 |
CEFOBID
NDA #050551 |
SUPPL-46 |
CEFOPERAZONE SODIUM |
PFIZER |
Labeling |
Approval |
| 09/18/2020 |
LEVETIRACETAM
ANDA #091338 |
SUPPL-12 |
LEVETIRACETAM |
TORRENT PHARMS LTD |
Labeling |
Approval |
| 09/18/2020 |
LEVETIRACETAM
ANDA #091338 |
SUPPL-13 |
LEVETIRACETAM |
TORRENT PHARMS LTD |
Labeling |
Approval |
| 09/18/2020 |
LEVETIRACETAM
ANDA #091338 |
SUPPL-15 |
LEVETIRACETAM |
TORRENT PHARMS LTD |
Labeling |
Approval |
| 09/18/2020 |
ILARIS
BLA #125319 |
SUPPL-100 |
CANAKINUMAB |
NOVARTIS PHARMS |
|
Approval |
| 09/18/2020 |
YERVOY
BLA #125377 |
SUPPL-112 |
IPILIMUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 09/18/2020 |
OPDIVO
BLA #125554 |
SUPPL-84 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 09/18/2020 |
OPDIVO
BLA #125554 |
SUPPL-85 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 09/18/2020 |
VINORELBINE TARTRATE
ANDA #200148 |
SUPPL-6 |
VINORELBINE TARTRATE |
RISING |
Labeling |
Approval |
| 09/18/2020 |
CINACALCET HYDROCHLORIDE
ANDA #208368 |
ORIG-1 |
CINACALCET HYDROCHLORIDE |
DR REDDYS |
|
Approval |
| 09/18/2020 |
ARMONAIR DIGIHALER
NDA #208798 |
SUPPL-7 |
FLUTICASONE PROPIONATE |
TEVA PHARM |
Labeling |
Approval |
| 09/18/2020 |
ARMONAIR RESPICLICK
NDA #208798 |
SUPPL-7 |
FLUTICASONE PROPIONATE |
TEVA PHARM |
Labeling |
Approval |
| 09/18/2020 |
MEFENAMIC ACID
ANDA #209209 |
ORIG-1 |
MEFENAMIC ACID |
CHARTWELL RX |
|
Approval |
| 09/18/2020 |
LORATADINE
ANDA #212795 |
ORIG-1 |
LORATADINE |
TENSHI |
|
Approval |
| 09/18/2020 |
POLIVY
BLA #761121 |
SUPPL-3 |
POLATUZUMAB VEDOTIN-PIIQ |
GENENTECH |
|
Approval |
| 09/21/2020 |
DONEPEZIL HYDROCHLORIDE
ANDA #200292 |
SUPPL-8 |
DONEPEZIL HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
| 09/21/2020 |
RIZATRIPTAN BENZOATE
ANDA #200482 |
SUPPL-1 |
RIZATRIPTAN BENZOATE |
NATCO PHARMA LTD |
Labeling |
Approval |
| 09/21/2020 |
RIZATRIPTAN BENZOATE
ANDA #200482 |
SUPPL-2 |
RIZATRIPTAN BENZOATE |
NATCO PHARMA LTD |
Labeling |
Approval |
| 09/21/2020 |
RIZATRIPTAN BENZOATE
ANDA #201967 |
SUPPL-3 |
RIZATRIPTAN BENZOATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 09/21/2020 |
RIZATRIPTAN BENZOATE
ANDA #201993 |
SUPPL-3 |
RIZATRIPTAN BENZOATE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 09/21/2020 |
RIZATRIPTAN BENZOATE
ANDA #201993 |
SUPPL-4 |
RIZATRIPTAN BENZOATE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 09/21/2020 |
DONEPEZIL HYDROCHLORIDE
ANDA #202114 |
SUPPL-2 |
DONEPEZIL HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 09/21/2020 |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ANDA #203647 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
STRIDES PHARMA |
|
Approval |
| 09/21/2020 |
AZACITIDINE
ANDA #207234 |
SUPPL-2 |
AZACITIDINE |
NATCO PHARMA LTD |
Labeling |
Approval |
| 09/21/2020 |
AZACITIDINE
ANDA #207234 |
SUPPL-3 |
AZACITIDINE |
NATCO PHARMA LTD |
Labeling |
Approval |
| 09/21/2020 |
PALBOCICLIB
ANDA #213098 |
ORIG-1 |
PALBOCICLIB |
ZYDUS WORLDWIDE DMCC |
|
Tentative Approval |
| 09/21/2020 |
CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #213105 |
ORIG-1 |
CETIRIZINE HYDROCHLORIDE |
CATALENT |
|
Approval |
| 09/21/2020 |
LIDOCAINE AND PRILOCAINE
ANDA #213253 |
ORIG-1 |
LIDOCAINE; PRILOCAINE |
RHODES PHARMS |
|
Approval |
| 09/21/2020 |
SUMATRIPTAN
ANDA #213465 |
ORIG-1 |
SUMATRIPTAN |
PADAGIS ISRAEL |
|
Approval |
| 09/21/2020 |
SUMATRIPTAN
ANDA #213650 |
ORIG-1 |
SUMATRIPTAN |
PERRIGO UK FINCO |
|
Approval |
| 09/21/2020 |
PILOCARPINE HYDROCHLORIDE
ANDA #214193 |
ORIG-1 |
PILOCARPINE HYDROCHLORIDE |
AMNEAL |
|
Approval |
| 09/22/2020 |
ERAXIS
NDA #021632 |
SUPPL-27 |
ANIDULAFUNGIN |
VICURON HOLDINGS |
Efficacy |
Approval |
| 09/22/2020 |
ERAXIS
NDA #021632 |
SUPPL-29 |
ANIDULAFUNGIN |
VICURON HOLDINGS |
Labeling |
Approval |
| 09/22/2020 |
AZACITIDINE
ANDA #201537 |
SUPPL-14 |
AZACITIDINE |
DR REDDYS |
Labeling |
Approval |
| 09/22/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #202274 |
SUPPL-1 |
VANCOMYCIN HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 09/22/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #202274 |
SUPPL-3 |
VANCOMYCIN HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 09/22/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #202275 |
SUPPL-1 |
VANCOMYCIN HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 09/22/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #202275 |
SUPPL-3 |
VANCOMYCIN HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 09/22/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #202275 |
SUPPL-4 |
VANCOMYCIN HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 09/22/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #202464 |
SUPPL-1 |
VANCOMYCIN HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 09/22/2020 |
VANCOMYCIN HYDROCHLORIDE
ANDA #202464 |
SUPPL-3 |
VANCOMYCIN HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 09/22/2020 |
LINZESS
NDA #202811 |
SUPPL-16 |
LINACLOTIDE |
ABBVIE |
Efficacy |
Approval |
| 09/22/2020 |
NAFTIFINE HYDROCHLORIDE
ANDA #210038 |
ORIG-1 |
NAFTIFINE HYDROCHLORIDE |
XIROMED |
|
Approval |
| 09/22/2020 |
ESOMEPRAZOLE MAGNESIUM
ANDA #213158 |
ORIG-1 |
ESOMEPRAZOLE MAGNESIUM |
CISEN |
|
Approval |
| 09/23/2020 |
TRAVASOL 10% IN PLASTIC CONTAINER
NDA #018931 |
SUPPL-55 |
AMINO ACIDS |
BAXTER HLTHCARE |
Labeling |
Approval |
| 09/23/2020 |
TRAVASOL 5.5% IN PLASTIC CONTAINER
NDA #018931 |
SUPPL-55 |
AMINO ACIDS |
BAXTER HLTHCARE |
Labeling |
Approval |
| 09/23/2020 |
TRAVASOL 8.5% IN PLASTIC CONTAINER
NDA #018931 |
SUPPL-55 |
AMINO ACIDS |
BAXTER HLTHCARE |
Labeling |
Approval |
| 09/23/2020 |
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER
NDA #020849 |
SUPPL-25 |
AMINO ACIDS |
BAXTER HLTHCARE |
Labeling |
Approval |
| 09/23/2020 |
TESTOSTERONE ENANTHATE
ANDA #040647 |
SUPPL-3 |
TESTOSTERONE ENANTHATE |
RISING |
Labeling |
Approval |
| 09/23/2020 |
CEFTRIAXONE
ANDA #065125 |
SUPPL-28 |
CEFTRIAXONE SODIUM |
LUPIN |
Labeling |
Approval |
| 09/23/2020 |
CEFTRIAXONE
ANDA #065125 |
SUPPL-29 |
CEFTRIAXONE SODIUM |
LUPIN |
Labeling |
Approval |
| 09/23/2020 |
ISOFLURANE
ANDA #075225 |
SUPPL-6 |
ISOFLURANE |
HALOCARBON PRODS |
Labeling |
Approval |
| 09/23/2020 |
TRAMADOL HYDROCHLORIDE
ANDA #203494 |
SUPPL-5 |
TRAMADOL HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 09/23/2020 |
TRAMADOL HYDROCHLORIDE
ANDA #203494 |
SUPPL-7 |
TRAMADOL HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 09/23/2020 |
TRAMADOL HYDROCHLORIDE
ANDA #203494 |
SUPPL-10 |
TRAMADOL HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 09/23/2020 |
TRAMADOL HYDROCHLORIDE
ANDA #203494 |
SUPPL-13 |
TRAMADOL HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 09/23/2020 |
TRAMADOL HYDROCHLORIDE
ANDA #203494 |
SUPPL-15 |
TRAMADOL HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 09/23/2020 |
TRAMADOL HYDROCHLORIDE
ANDA #203494 |
SUPPL-16 |
TRAMADOL HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Manufacturing (CMC) |
Approval |
| 09/23/2020 |
DOCETAXEL
ANDA #207563 |
SUPPL-5 |
DOCETAXEL |
NOVAST LABS |
Labeling |
Approval |
| 09/23/2020 |
LUMIFY
NDA #208144 |
SUPPL-11 |
BRIMONIDINE TARTRATE |
BAUSCH AND LOMB INC |
Labeling |
Approval |
| 09/23/2020 |
DOCETAXEL
ANDA #208859 |
SUPPL-4 |
DOCETAXEL |
MYLAN LABS LTD |
Labeling |
Approval |
| 09/23/2020 |
HYDROMORPHONE HYDROCHLORIDE
ANDA #212133 |
ORIG-1 |
HYDROMORPHONE HYDROCHLORIDE |
ASCENT PHARMS INC |
|
Approval |
| 09/24/2020 |
ARTHROTEC
NDA #020607 |
SUPPL-36 |
DICLOFENAC SODIUM; MISOPROSTOL |
PFIZER |
Labeling |
Approval |
| 09/24/2020 |
IMPLANON
NDA #021529 |
SUPPL-19 |
ETONOGESTREL |
ORGANON |
Labeling |
Approval |
| 09/24/2020 |
IMPLANON
NDA #021529 |
SUPPL-20 |
ETONOGESTREL |
ORGANON |
Labeling |
Approval |
| 09/24/2020 |
NEXPLANON
NDA #021529 |
SUPPL-19 |
ETONOGESTREL |
ORGANON |
Labeling |
Approval |
| 09/24/2020 |
NEXPLANON
NDA #021529 |
SUPPL-20 |
ETONOGESTREL |
ORGANON |
Labeling |
Approval |
| 09/24/2020 |
REYATAZ
NDA #021567 |
SUPPL-44 |
ATAZANAVIR SULFATE |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
| 09/24/2020 |
REVLIMID
NDA #021880 |
SUPPL-54 |
LENALIDOMIDE |
BRISTOL MYERS SQUIBB |
REMS |
Approval |
| 09/24/2020 |
BENLYSTA
BLA #125370 |
SUPPL-71 |
BELIMUMAB |
HUMAN GENOME SCIENCES INC. |
|
Approval |
| 09/24/2020 |
STIVARGA
NDA #203085 |
SUPPL-12 |
REGORAFENIB |
BAYER HLTHCARE |
Labeling |
Approval |
| 09/24/2020 |
KALYDECO
NDA #203188 |
SUPPL-33 |
IVACAFTOR |
VERTEX PHARMS |
Efficacy |
Approval |
| 09/24/2020 |
REYATAZ
NDA #206352 |
SUPPL-8 |
ATAZANAVIR SULFATE |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
| 09/24/2020 |
KALYDECO
NDA #207925 |
SUPPL-11 |
IVACAFTOR |
VERTEX PHARMS INC |
Efficacy |
Approval |
| 09/24/2020 |
ALAWAY
ANDA #208158 |
ORIG-1 |
KETOTIFEN FUMARATE |
BAUSCH AND LOMB INC |
|
Approval |
| 09/24/2020 |
DIMETHYL FUMARATE
ANDA #210305 |
ORIG-1 |
DIMETHYL FUMARATE |
CIPLA |
|
Approval |
| 09/24/2020 |
DIMETHYL FUMARATE
ANDA #210402 |
ORIG-1 |
DIMETHYL FUMARATE |
AMNEAL |
|
Approval |
| 09/24/2020 |
DIMETHYL FUMARATE
ANDA #210440 |
ORIG-1 |
DIMETHYL FUMARATE |
ALKEM LABS LTD |
|
Approval |
| 09/24/2020 |
DIMETHYL FUMARATE
ANDA #210460 |
ORIG-1 |
DIMETHYL FUMARATE |
MSN |
|
Approval |
| 09/24/2020 |
DIMETHYL FUMARATE
ANDA #210499 |
ORIG-1 |
DIMETHYL FUMARATE |
ACCORD HLTHCARE |
|
Approval |
| 09/24/2020 |
DIMETHYL FUMARATE
ANDA #210500 |
ORIG-1 |
DIMETHYL FUMARATE |
HETERO LABS LTD III |
|
Approval |
| 09/24/2020 |
DIMETHYL FUMARATE
ANDA #210538 |
ORIG-1 |
DIMETHYL FUMARATE |
ZYDUS PHARMS |
|
Approval |
| 09/24/2020 |
NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
ANDA #213663 |
ORIG-1 |
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM |
GRANULES |
|
Approval |
| 09/24/2020 |
CYANOCOBALAMIN
ANDA #214390 |
ORIG-1 |
CYANOCOBALAMIN |
GLAND PHARMA LTD |
|
Approval |
| 09/25/2020 |
ZOCOR
NDA #019766 |
SUPPL-101 |
SIMVASTATIN |
ORGANON |
Labeling |
Approval |
| 09/25/2020 |
PRAVACHOL
NDA #019898 |
SUPPL-69 |
PRAVASTATIN SODIUM |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
| 09/25/2020 |
LIPITOR
NDA #020702 |
SUPPL-78 |
ATORVASTATIN CALCIUM |
UPJOHN |
Labeling |
Approval |
| 09/25/2020 |
LESCOL XL
NDA #021192 |
SUPPL-31 |
FLUVASTATIN SODIUM |
SANDOZ |
Labeling |
Approval |
| 09/25/2020 |
XYREM
NDA #021196 |
SUPPL-32 |
SODIUM OXYBATE |
JAZZ PHARMS |
Efficacy |
Approval |
| 09/25/2020 |
ALTOPREV
NDA #021316 |
SUPPL-36 |
LOVASTATIN |
COVIS |
Labeling |
Approval |
| 09/25/2020 |
CRESTOR
NDA #021366 |
SUPPL-42 |
ROSUVASTATIN CALCIUM |
IPR |
Labeling |
Approval |
| 09/25/2020 |
CADUET
NDA #021540 |
SUPPL-48 |
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM |
PHARMACIA |
Labeling |
Approval |
| 09/25/2020 |
VYTORIN
NDA #021687 |
SUPPL-63 |
EZETIMIBE; SIMVASTATIN |
ORGANON |
Labeling |
Approval |
| 09/25/2020 |
LIVALO
NDA #022363 |
SUPPL-18 |
PITAVASTATIN CALCIUM |
KOWA CO |
Labeling |
Approval |
| 09/25/2020 |
LOVASTATIN
ANDA #075300 |
SUPPL-10 |
LOVASTATIN |
CHARTWELL RX |
Labeling |
Approval |
| 09/25/2020 |
LOVASTATIN
ANDA #075451 |
SUPPL-25 |
LOVASTATIN |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 09/25/2020 |
LOVASTATIN
ANDA #075551 |
SUPPL-28 |
LOVASTATIN |
TEVA |
Labeling |
Approval |
| 09/25/2020 |
LOVASTATIN
ANDA #075551 |
SUPPL-29 |
LOVASTATIN |
TEVA |
Labeling |
Approval |
| 09/25/2020 |
LOVASTATIN
ANDA #075636 |
SUPPL-32 |
LOVASTATIN |
EPIC PHARMA LLC |
Labeling |
Approval |
| 09/25/2020 |
LOVASTATIN
ANDA #075828 |
SUPPL-39 |
LOVASTATIN |
ACTAVIS ELIZABETH |
Labeling |
Approval |
| 09/25/2020 |
LOVASTATIN
ANDA #075935 |
SUPPL-8 |
LOVASTATIN |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 09/25/2020 |
FAMOTIDINE
ANDA #075942 |
SUPPL-12 |
FAMOTIDINE |
APOTEX INC |
Labeling |
Approval |
| 09/25/2020 |
LOVASTATIN
ANDA #075991 |
SUPPL-21 |
LOVASTATIN |
CARLSBAD |
Labeling |
Approval |
| 09/25/2020 |
FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK)
ANDA #076322 |
SUPPL-11 |
FAMOTIDINE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 09/25/2020 |
FAMOTIDINE PRESERVATIVE FREE
ANDA #076324 |
SUPPL-11 |
FAMOTIDINE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 09/25/2020 |
MIRTAZAPINE
ANDA #076541 |
SUPPL-25 |
MIRTAZAPINE |
SUN PHARM INDS INC |
Labeling |
Approval |
| 09/25/2020 |
MIRTAZAPINE
ANDA #076541 |
SUPPL-26 |
MIRTAZAPINE |
SUN PHARM INDS INC |
Labeling |
Approval |
| 09/25/2020 |
LOVASTATIN
ANDA #077748 |
SUPPL-6 |
LOVASTATIN |
COREPHARMA |
Labeling |
Approval |
| 09/25/2020 |
LOVASTATIN
ANDA #078296 |
SUPPL-26 |
LOVASTATIN |
LUPIN |
Labeling |
Approval |
| 09/25/2020 |
FLUVASTATIN SODIUM
ANDA #078407 |
SUPPL-5 |
FLUVASTATIN SODIUM |
TEVA PHARMS |
Labeling |
Approval |
| 09/25/2020 |
FLUVASTATIN SODIUM
ANDA #090595 |
SUPPL-7 |
FLUVASTATIN SODIUM |
MYLAN PHARMS INC |
Labeling |
Approval |
| 09/25/2020 |
CAMPATH
BLA #103948 |
SUPPL-5177 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 09/25/2020 |
CAMPATH
BLA #103948 |
SUPPL-5179 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 09/25/2020 |
LEMTRADA
BLA #103948 |
SUPPL-5177 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 09/25/2020 |
LEMTRADA
BLA #103948 |
SUPPL-5179 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
| 09/25/2020 |
NUCALA
BLA #125526 |
SUPPL-17 |
MEPOLIZUMAB |
GLAXOSMITHKLINE LLC |
|
Approval |
| 09/25/2020 |
OPDIVO
BLA #125554 |
SUPPL-86 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
| 09/25/2020 |
LIPTRUZET
NDA #200153 |
SUPPL-12 |
ATORVASTATIN CALCIUM; EZETIMIBE |
ORGANON |
Labeling |
Approval |
| 09/25/2020 |
XELJANZ
NDA #203214 |
SUPPL-26 |
TOFACITINIB CITRATE |
PF PRISM CV |
Efficacy |
Approval |
| 09/25/2020 |
FLOLIPID
NDA #206679 |
SUPPL-3 |
SIMVASTATIN |
SALERNO PHARMS |
Labeling |
Approval |
| 09/25/2020 |
ZYPITAMAG
NDA #208379 |
SUPPL-4 |
PITAVASTATIN MAGNESIUM |
MEDICURE |
Labeling |
Approval |
| 09/25/2020 |
GALAFOLD
NDA #208623 |
SUPPL-3 |
MIGALASTAT HYDROCHLORIDE |
AMICUS THERAP US |
Labeling |
Approval |
| 09/25/2020 |
EZALLOR SPRINKLE
NDA #208647 |
SUPPL-4 |
ROSUVASTATIN CALCIUM |
SUN PHARM |
Labeling |
Approval |
| 09/25/2020 |
FETROJA
NDA #209445 |
SUPPL-2 |
CEFIDEROCOL SULFATE TOSYLATE |
SHIONOGI INC |
Efficacy |
Approval |
| 09/25/2020 |
NIKITA
NDA #209875 |
SUPPL-2 |
PITAVASTATIN SODIUM |
LUPIN LTD |
Labeling |
Approval |
| 09/25/2020 |
ICATIBANT ACETATE
ANDA #210118 |
SUPPL-2 |
ICATIBANT ACETATE |
TEVA PHARMS USA |
Labeling |
Approval |
| 09/25/2020 |
ICATIBANT ACETATE
ANDA #211021 |
SUPPL-3 |
ICATIBANT ACETATE |
JIANGSU HANSOH PHARM |
Labeling |
Approval |
| 09/25/2020 |
XELJANZ
NDA #213082 |
ORIG-1 |
TOFACITINIB CITRATE |
PFIZER |
Type 3 - New Dosage Form |
Approval |
| 09/25/2020 |
NUCALA
BLA #761122 |
SUPPL-5 |
MEPOLIZUMAB |
GLAXOSMITHKLINE |
|
Approval |
| 09/27/2020 |
COMBIVENT RESPIMAT
NDA #021747 |
SUPPL-20 |
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 09/27/2020 |
KADCYLA
BLA #125427 |
SUPPL-108 |
ADO-TRASTUZUMAB EMTANSINE |
GENENTECH |
|
Approval |
| 09/28/2020 |
TEKTURNA HCT
NDA #022107 |
SUPPL-34 |
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE |
NODEN PHARMA |
Labeling |
Approval |
| 09/28/2020 |
NOREPINEPHRINE BITARTRATE
ANDA #040455 |
SUPPL-22 |
NOREPINEPHRINE BITARTRATE |
MEITHEAL |
Labeling |
Approval |
| 09/28/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #075049 |
SUPPL-35 |
FLUOXETINE HYDROCHLORIDE |
APNAR PHARMA LP |
Labeling |
Approval |
| 09/28/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #075049 |
SUPPL-36 |
FLUOXETINE HYDROCHLORIDE |
APNAR PHARMA LP |
Labeling |
Approval |
| 09/28/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #075049 |
SUPPL-39 |
FLUOXETINE HYDROCHLORIDE |
APNAR PHARMA LP |
Labeling |
Approval |
| 09/28/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #075049 |
SUPPL-40 |
FLUOXETINE HYDROCHLORIDE |
APNAR PHARMA LP |
Labeling |
Approval |
| 09/28/2020 |
FLUOXETINE HYDROCHLORIDE
ANDA #075049 |
SUPPL-42 |
FLUOXETINE HYDROCHLORIDE |
APNAR PHARMA LP |
Labeling |
Approval |
| 09/28/2020 |
THIAMINE HYDROCHLORIDE
ANDA #080575 |
SUPPL-19 |
THIAMINE HYDROCHLORIDE |
WEST-WARD PHARMS INT |
Manufacturing (CMC) |
Approval |
| 09/28/2020 |
PHENYTOIN SODIUM
ANDA #084307 |
SUPPL-48 |
PHENYTOIN SODIUM |
HIKMA |
Labeling |
Approval |
| 09/28/2020 |
PHENYTOIN SODIUM
ANDA #084307 |
SUPPL-49 |
PHENYTOIN SODIUM |
HIKMA |
Labeling |
Approval |
| 09/28/2020 |
PHENYTOIN SODIUM
ANDA #084307 |
SUPPL-51 |
PHENYTOIN SODIUM |
HIKMA |
Labeling |
Approval |
| 09/28/2020 |
PHENYTOIN SODIUM
ANDA #084307 |
SUPPL-54 |
PHENYTOIN SODIUM |
HIKMA |
Labeling |
Approval |
| 09/28/2020 |
PHENYTOIN SODIUM
ANDA #084307 |
SUPPL-56 |
PHENYTOIN SODIUM |
HIKMA |
Labeling |
Approval |
| 09/28/2020 |
PHENYTOIN SODIUM
ANDA #084307 |
SUPPL-57 |
PHENYTOIN SODIUM |
HIKMA |
Labeling |
Approval |
| 09/28/2020 |
PHENYTOIN SODIUM
ANDA #084307 |
SUPPL-60 |
PHENYTOIN SODIUM |
HIKMA |
Labeling |
Approval |
| 09/28/2020 |
DOCETAXEL
ANDA #210327 |
SUPPL-1 |
DOCETAXEL |
SHILPA |
Labeling |
Approval |
| 09/28/2020 |
DOCETAXEL
ANDA #210327 |
SUPPL-2 |
DOCETAXEL |
SHILPA |
Labeling |
Approval |
| 09/28/2020 |
DOCETAXEL
ANDA #210327 |
SUPPL-3 |
DOCETAXEL |
SHILPA |
Labeling |
Approval |
| 09/28/2020 |
BUPROPION HYDROCHLORIDE
ANDA #211347 |
SUPPL-1 |
BUPROPION HYDROCHLORIDE |
YICHANG HUMANWELL |
Labeling |
Approval |
| 09/28/2020 |
ESTRADIOL
ANDA #211396 |
ORIG-1 |
ESTRADIOL |
AMNEAL |
|
Approval |
| 09/29/2020 |
LUMIGAN
NDA #022184 |
SUPPL-8 |
BIMATOPROST |
ABBVIE |
Labeling |
Approval |
| 09/29/2020 |
LATISSE
NDA #022369 |
SUPPL-12 |
BIMATOPROST |
ABBVIE |
Labeling |
Approval |
| 09/29/2020 |
INDOCYANINE GREEN
ANDA #040811 |
SUPPL-6 |
INDOCYANINE GREEN |
RENEW PHARMS |
Labeling |
Approval |
| 09/29/2020 |
ALMOTRIPTAN MALATE
ANDA #078027 |
SUPPL-2 |
ALMOTRIPTAN MALATE |
TEVA PHARMS USA |
Labeling |
Approval |
| 09/29/2020 |
HEPARIN SODIUM
ANDA #091682 |
SUPPL-13 |
HEPARIN SODIUM |
SANDOZ |
Labeling |
Approval |
| 09/29/2020 |
SIMPONI ARIA
BLA #125433 |
SUPPL-30 |
GOLIMUMAB |
JANSSEN BIOTECH |
|
Approval |
| 09/29/2020 |
SIMPONI ARIA
BLA #125433 |
SUPPL-31 |
GOLIMUMAB |
JANSSEN BIOTECH |
|
Approval |
| 09/29/2020 |
UNITUXIN
BLA #125516 |
SUPPL-25 |
DINUTUXIMAB |
UNITED THERAP |
|
Approval |
| 09/29/2020 |
HEPARIN SODIUM
ANDA #201002 |
SUPPL-9 |
HEPARIN SODIUM |
SANDOZ |
Labeling |
Approval |
| 09/29/2020 |
LAPATINIB DITOSYLATE
ANDA #203007 |
ORIG-1 |
LAPATINIB DITOSYLATE |
NATCO PHARMA LTD |
|
Approval |
| 09/29/2020 |
ALBUTEROL SULFATE
ANDA #203760 |
SUPPL-2 |
ALBUTEROL SULFATE |
PADAGIS US |
Manufacturing (CMC) |
Approval |
| 09/29/2020 |
GABAPENTIN
ANDA #204989 |
SUPPL-4 |
GABAPENTIN |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 09/29/2020 |
GABAPENTIN
ANDA #204989 |
SUPPL-6 |
GABAPENTIN |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 09/29/2020 |
GABAPENTIN
ANDA #204989 |
SUPPL-7 |
GABAPENTIN |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 09/29/2020 |
GABAPENTIN
ANDA #204989 |
SUPPL-9 |
GABAPENTIN |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 09/29/2020 |
GABAPENTIN
ANDA #204989 |
SUPPL-19 |
GABAPENTIN |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 09/29/2020 |
GABAPENTIN
ANDA #205101 |
SUPPL-4 |
GABAPENTIN |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 09/29/2020 |
GABAPENTIN
ANDA #205101 |
SUPPL-6 |
GABAPENTIN |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 09/29/2020 |
GABAPENTIN
ANDA #205101 |
SUPPL-7 |
GABAPENTIN |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 09/29/2020 |
GABAPENTIN
ANDA #205101 |
SUPPL-8 |
GABAPENTIN |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 09/29/2020 |
GABAPENTIN
ANDA #205101 |
SUPPL-18 |
GABAPENTIN |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 09/29/2020 |
PROAIR DIGIHALER
NDA #205636 |
SUPPL-20 |
ALBUTEROL SULFATE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 09/29/2020 |
PROAIR RESPICLICK
NDA #205636 |
SUPPL-20 |
ALBUTEROL SULFATE |
TEVA BRANDED PHARM |
Labeling |
Approval |
| 09/29/2020 |
DOLUTEGRAVIR
ANDA #209565 |
ORIG-1 |
DOLUTEGRAVIR |
HETERO LABS UNIT III |
|
Tentative Approval |
| 09/29/2020 |
HEPARIN SODIUM
ANDA #211004 |
SUPPL-3 |
HEPARIN SODIUM |
NANJING KING-FRIEND |
Labeling |
Approval |
| 09/29/2020 |
HEPARIN SODIUM
ANDA #211005 |
SUPPL-3 |
HEPARIN SODIUM |
NANJING KING-FRIEND |
Labeling |
Approval |
| 09/29/2020 |
ALKINDI SPRINKLE
NDA #213876 |
ORIG-1 |
HYDROCORTISONE |
ETON |
Type 3 - New Dosage Form |
Approval |
| 09/29/2020 |
ATROPINE SULFATE
NDA #214652 |
ORIG-1 |
ATROPINE SULFATE |
ACCORD HLTHCARE |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 09/30/2020 |
PATADAY TWICE DAILY RELIEF
NDA #020688 |
SUPPL-33 |
OLOPATADINE HYDROCHLORIDE |
ALCON LABS INC |
Labeling |
Approval |
| 09/30/2020 |
KEPPRA
NDA #021035 |
SUPPL-104 |
LEVETIRACETAM |
UCB INC |
Labeling |
Approval |
| 09/30/2020 |
KEPPRA
NDA #021505 |
SUPPL-44 |
LEVETIRACETAM |
UCB INC |
Labeling |
Approval |
| 09/30/2020 |
PATADAY ONCE DAILY RELIEF
NDA #021545 |
SUPPL-23 |
OLOPATADINE HYDROCHLORIDE |
ALCON LABS INC |
Labeling |
Approval |
| 09/30/2020 |
KEPPRA
NDA #021872 |
SUPPL-29 |
LEVETIRACETAM |
UCB INC |
Labeling |
Approval |
| 09/30/2020 |
KEPPRA XR
NDA #022285 |
SUPPL-29 |
LEVETIRACETAM |
UCB INC |
Labeling |
Approval |
| 09/30/2020 |
PHOSLYRA
NDA #022581 |
SUPPL-10 |
CALCIUM ACETATE |
FRESENIUS MEDCL |
Labeling |
Approval |
| 09/30/2020 |
TIMOLOL MALEATE
ANDA #074465 |
SUPPL-6 |
TIMOLOL MALEATE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 09/30/2020 |
TIMOLOL MALEATE
ANDA #074466 |
SUPPL-6 |
TIMOLOL MALEATE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 09/30/2020 |
LOSARTAN POTASSIUM
ANDA #077424 |
SUPPL-14 |
LOSARTAN POTASSIUM |
CHARTWELL RX |
Labeling |
Approval |
| 09/30/2020 |
LOSARTAN POTASSIUM
ANDA #077459 |
SUPPL-12 |
LOSARTAN POTASSIUM |
HIKMA |
Labeling |
Approval |
| 09/30/2020 |
LOSARTAN POTASSIUM
ANDA #078232 |
SUPPL-30 |
LOSARTAN POTASSIUM |
LUPIN LTD |
Labeling |
Approval |
| 09/30/2020 |
MONTELUKAST SODIUM
ANDA #090655 |
SUPPL-6 |
MONTELUKAST SODIUM |
HIKMA |
Labeling |
Approval |
| 09/30/2020 |
MONTELUKAST SODIUM
ANDA #091128 |
SUPPL-6 |
MONTELUKAST SODIUM |
HIKMA |
Labeling |
Approval |
| 09/30/2020 |
AVASTIN
BLA #125085 |
SUPPL-334 |
BEVACIZUMAB |
GENENTECH |
|
Approval |
| 09/30/2020 |
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA #203997 |
ORIG-1 |
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
BIONPHARMA |
|
Approval |
| 09/30/2020 |
ELETRIPTAN HYDROBROMIDE
ANDA #205152 |
SUPPL-1 |
ELETRIPTAN HYDROBROMIDE |
MYLAN |
Labeling |
Approval |
| 09/30/2020 |
LABETALOL HYDROCHLORIDE
ANDA #212990 |
ORIG-1 |
LABETALOL HYDROCHLORIDE |
EPIC PHARMA LLC |
|
Approval |
| 09/30/2020 |
TECENTRIQ
BLA #761034 |
SUPPL-29 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
