11/01/2019 |
PACERONE ANDA #075135 |
SUPPL-26 |
AMIODARONE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
11/01/2019 |
PACERONE ANDA #075135 |
SUPPL-27 |
AMIODARONE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
11/01/2019 |
PACERONE ANDA #075135 |
SUPPL-35 |
AMIODARONE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
11/01/2019 |
PACERONE ANDA #075135 |
SUPPL-49 |
AMIODARONE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
11/01/2019 |
PACERONE ANDA #075135 |
SUPPL-51 |
AMIODARONE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
11/01/2019 |
PACERONE ANDA #075135 |
SUPPL-52 |
AMIODARONE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
11/01/2019 |
PACERONE ANDA #075135 |
SUPPL-54 |
AMIODARONE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
11/01/2019 |
NICOTINE POLACRILEX ANDA #076775 |
SUPPL-24 |
NICOTINE POLACRILEX |
L PERRIGO CO |
Labeling |
Approval |
11/01/2019 |
NICOTINE POLACRILEX ANDA #078325 |
SUPPL-15 |
NICOTINE POLACRILEX |
PERRIGO R AND D |
Labeling |
Approval |
11/01/2019 |
NICOTINE POLACRILEX ANDA #078326 |
SUPPL-15 |
NICOTINE POLACRILEX |
PERRIGO R AND D |
Labeling |
Approval |
11/01/2019 |
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE ANDA #089534 |
SUPPL-46 |
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
11/01/2019 |
FABRAZYME BLA #103979 |
SUPPL-5306 |
AGALSIDASE BETA |
GENZYME |
|
Approval |
11/01/2019 |
TESTOSTERONE ANDA #204570 |
SUPPL-2 |
TESTOSTERONE |
ACTAVIS LABS UT INC |
Labeling |
Approval |
11/01/2019 |
QUINAPRIL HYDROCHLORIDE ANDA #205823 |
SUPPL-2 |
QUINAPRIL HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
11/01/2019 |
BOSENTAN ANDA #207760 |
SUPPL-1 |
BOSENTAN |
ZYDUS PHARMS |
Labeling |
Approval |
11/01/2019 |
ABIRATERONE ACETATE ANDA #208446 |
SUPPL-3 |
ABIRATERONE ACETATE |
MYLAN |
Labeling |
Approval |
11/01/2019 |
ENDARI NDA #208587 |
SUPPL-1 |
L-GLUTAMINE |
EMMAUS MEDCL |
Labeling |
Approval |
11/01/2019 |
RADICAVA NDA #209176 |
SUPPL-9 |
EDARAVONE |
MITSUBISHI TANABE |
Labeling |
Approval |
11/01/2019 |
BOSENTAN ANDA #209324 |
SUPPL-1 |
BOSENTAN |
SUN PHARM |
Labeling |
Approval |
11/01/2019 |
AMMONIA N 13 ANDA #209507 |
ORIG-1 |
AMMONIA N-13 |
UNIV TX SW MEDCTR |
|
Approval |
11/01/2019 |
ATOVAQUONE ANDA #209685 |
SUPPL-1 |
ATOVAQUONE |
GLENMARK SPECLT |
Labeling |
Approval |
11/01/2019 |
ATOVAQUONE ANDA #209685 |
SUPPL-2 |
ATOVAQUONE |
GLENMARK SPECLT |
Labeling |
Approval |
11/01/2019 |
CLARISCAN ANDA #210016 |
ORIG-1 |
GADOTERATE MEGLUMINE |
GE HEALTHCARE |
|
Approval |
11/01/2019 |
LINEZOLID ANDA #210702 |
SUPPL-1 |
LINEZOLID |
CHARTWELL RX |
Manufacturing (CMC) |
Approval |
11/01/2019 |
ERYTHROMYCIN ETHYLSUCCINATE ANDA #211204 |
ORIG-1 |
ERYTHROMYCIN ETHYLSUCCINATE |
AMNEAL PHARMS |
|
Approval |
11/01/2019 |
IBRANCE NDA #212436 |
ORIG-1 |
PALBOCICLIB |
PFIZER |
Type 3 - New Dosage Form |
Approval |
11/01/2019 |
TALICIA NDA #213004 |
ORIG-1 |
AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN |
REDHILL |
Type 4 - New Combination |
Approval |
11/04/2019 |
OCTREOTIDE ACETATE ANDA #075957 |
SUPPL-28 |
OCTREOTIDE ACETATE |
MEITHEAL |
Labeling |
Approval |
11/04/2019 |
OCTREOTIDE ACETATE ANDA #075959 |
SUPPL-29 |
OCTREOTIDE ACETATE |
MEITHEAL |
Labeling |
Approval |
11/04/2019 |
METFORMIN HYDROCHLORIDE ANDA #075967 |
SUPPL-37 |
METFORMIN HYDROCHLORIDE |
SUN PHARM INDS INC |
Labeling |
Approval |
11/04/2019 |
METFORMIN HYDROCHLORIDE ANDA #075967 |
SUPPL-38 |
METFORMIN HYDROCHLORIDE |
SUN PHARM INDS INC |
Labeling |
Approval |
11/04/2019 |
MIDODRINE HYDROCHLORIDE ANDA #076577 |
SUPPL-8 |
MIDODRINE HYDROCHLORIDE |
MYLAN PHARMS INC |
Labeling |
Approval |
11/04/2019 |
ZALEPLON ANDA #077505 |
SUPPL-1 |
ZALEPLON |
CHARTWELL MOLECULAR |
Labeling |
Approval |
11/04/2019 |
ZALEPLON ANDA #077505 |
SUPPL-2 |
ZALEPLON |
CHARTWELL MOLECULAR |
Labeling |
Approval |
11/04/2019 |
ZALEPLON ANDA #077505 |
SUPPL-3 |
ZALEPLON |
CHARTWELL MOLECULAR |
Labeling |
Approval |
11/04/2019 |
ATORVASTATIN CALCIUM ANDA #077575 |
SUPPL-9 |
ATORVASTATIN CALCIUM |
SANDOZ INC |
Labeling |
Approval |
11/04/2019 |
ATORVASTATIN CALCIUM ANDA #077575 |
SUPPL-11 |
ATORVASTATIN CALCIUM |
SANDOZ INC |
Labeling |
Approval |
11/04/2019 |
FOSPHENYTOIN SODIUM ANDA #078052 |
SUPPL-8 |
FOSPHENYTOIN SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
11/04/2019 |
FOSPHENYTOIN SODIUM ANDA #078052 |
SUPPL-10 |
FOSPHENYTOIN SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
11/04/2019 |
FOSPHENYTOIN SODIUM ANDA #078052 |
SUPPL-11 |
FOSPHENYTOIN SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
11/04/2019 |
FOSPHENYTOIN SODIUM ANDA #078052 |
SUPPL-12 |
FOSPHENYTOIN SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
11/04/2019 |
METRONIDAZOLE ANDA #079065 |
SUPPL-8 |
METRONIDAZOLE |
ALEMBIC |
Labeling |
Approval |
11/04/2019 |
METRONIDAZOLE ANDA #079065 |
SUPPL-10 |
METRONIDAZOLE |
ALEMBIC |
Labeling |
Approval |
11/04/2019 |
ATORVASTATIN CALCIUM ANDA #090548 |
SUPPL-23 |
ATORVASTATIN CALCIUM |
APOTEX INC |
Labeling |
Approval |
11/04/2019 |
ESZOPICLONE ANDA #091151 |
SUPPL-6 |
ESZOPICLONE |
MYLAN PHARMS INC |
Labeling |
Approval |
11/04/2019 |
ESZOPICLONE ANDA #091151 |
SUPPL-8 |
ESZOPICLONE |
MYLAN PHARMS INC |
Labeling |
Approval |
11/04/2019 |
ESZOPICLONE ANDA #091151 |
SUPPL-9 |
ESZOPICLONE |
MYLAN PHARMS INC |
Labeling |
Approval |
11/04/2019 |
AZELASTINE HYDROCHLORIDE ANDA #201846 |
SUPPL-8 |
AZELASTINE HYDROCHLORIDE |
APOTEX INC |
Labeling |
Approval |
11/04/2019 |
TELMISARTAN ANDA #204164 |
SUPPL-2 |
TELMISARTAN |
JUBILANT GENERICS |
Labeling |
Approval |
11/04/2019 |
BOSENTAN ANDA #205699 |
SUPPL-1 |
BOSENTAN |
ENDO OPERATIONS |
Labeling |
Approval |
11/04/2019 |
PRASUGREL ANDA #205790 |
SUPPL-1 |
PRASUGREL HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
11/04/2019 |
PRASUGREL ANDA #205790 |
SUPPL-2 |
PRASUGREL HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
11/04/2019 |
PRASUGREL ANDA #205888 |
SUPPL-1 |
PRASUGREL HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/04/2019 |
PRASUGREL ANDA #205888 |
SUPPL-2 |
PRASUGREL HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/04/2019 |
PRASUGREL ANDA #205913 |
SUPPL-1 |
PRASUGREL HYDROCHLORIDE |
AMNEAL PHARMS |
Labeling |
Approval |
11/04/2019 |
PRASUGREL ANDA #205987 |
SUPPL-1 |
PRASUGREL HYDROCHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
11/04/2019 |
PRASUGREL ANDA #205987 |
SUPPL-2 |
PRASUGREL HYDROCHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
11/04/2019 |
TELMISARTAN ANDA #207016 |
SUPPL-2 |
TELMISARTAN |
MICRO LABS |
Labeling |
Approval |
11/04/2019 |
TELMISARTAN ANDA #207016 |
SUPPL-4 |
TELMISARTAN |
MICRO LABS |
Labeling |
Approval |
11/04/2019 |
BOSENTAN ANDA #207110 |
SUPPL-2 |
BOSENTAN |
WATSON LABS INC |
Labeling |
Approval |
11/04/2019 |
ABIRATERONE ACETATE ANDA #208327 |
SUPPL-3 |
ABIRATERONE ACETATE |
AMNEAL PHARMS |
Labeling |
Approval |
11/04/2019 |
ESZOPICLONE ANDA #208451 |
SUPPL-2 |
ESZOPICLONE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/04/2019 |
ESZOPICLONE ANDA #208451 |
SUPPL-3 |
ESZOPICLONE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/04/2019 |
ESZOPICLONE ANDA #208451 |
SUPPL-5 |
ESZOPICLONE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/04/2019 |
BOSENTAN ANDA #209742 |
SUPPL-2 |
BOSENTAN |
AMNEAL PHARMS CO |
Labeling |
Approval |
11/04/2019 |
ROSUVASTATIN CALCIUM ANDA #212059 |
ORIG-1 |
ROSUVASTATIN CALCIUM |
ZHEJIANG YONGTAI |
|
Approval |
11/04/2019 |
CISATRACURIUM BESYLATE ANDA #212171 |
ORIG-1 |
CISATRACURIUM BESYLATE |
ZYDUS PHARMS |
|
Approval |
11/04/2019 |
ENTECAVIR ANDA #212201 |
ORIG-1 |
ENTECAVIR |
YAOPHARMA CO LTD |
|
Approval |
11/04/2019 |
NALOXONE HYDROCHLORIDE ANDA #212456 |
ORIG-1 |
NALOXONE HYDROCHLORIDE |
EUGIA PHARMA |
|
Approval |
11/04/2019 |
ZIEXTENZO BLA #761045 |
ORIG-1 |
PEGFILGRASTIM-BMEZ |
SANDOZ INC |
|
Approval |
11/05/2019 |
WELLBUTRIN NDA #018644 |
SUPPL-54 |
BUPROPION HYDROCHLORIDE |
GLAXOSMITHKLINE |
Labeling |
Approval |
11/05/2019 |
WELLBUTRIN SR NDA #020358 |
SUPPL-61 |
BUPROPION HYDROCHLORIDE |
GLAXOSMITHKLINE |
Labeling |
Approval |
11/05/2019 |
ACTONEL NDA #020835 |
SUPPL-52 |
RISEDRONATE SODIUM |
APIL |
Labeling |
Approval |
11/05/2019 |
WELLBUTRIN XL NDA #021515 |
SUPPL-40 |
BUPROPION HYDROCHLORIDE |
BAUSCH |
Labeling |
Approval |
11/05/2019 |
MOVIPREP NDA #021881 |
SUPPL-20 |
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE |
SALIX PHARMS |
Labeling |
Approval |
11/05/2019 |
SORILUX NDA #022563 |
SUPPL-7 |
CALCIPOTRIENE |
MAYNE PHARMA |
Efficacy |
Approval |
11/05/2019 |
SORILUX NDA #022563 |
SUPPL-8 |
CALCIPOTRIENE |
MAYNE PHARMA |
Labeling |
Approval |
11/05/2019 |
ERYTHROCIN NDA #050609 |
SUPPL-41 |
ERYTHROMYCIN LACTOBIONATE |
HOSPIRA |
Labeling |
Approval |
11/05/2019 |
METRONIDAZOLE ANDA #070772 |
SUPPL-39 |
METRONIDAZOLE |
INNOGENIX |
Labeling |
Approval |
11/05/2019 |
METRONIDAZOLE ANDA #070772 |
SUPPL-41 |
METRONIDAZOLE |
INNOGENIX |
Labeling |
Approval |
11/05/2019 |
METFORMIN HYDROCHLORIDE ANDA #076756 |
SUPPL-4 |
METFORMIN HYDROCHLORIDE |
NOSTRUM PHARMS LLC |
Labeling |
Approval |
11/05/2019 |
METFORMIN HYDROCHLORIDE ANDA #076756 |
SUPPL-7 |
METFORMIN HYDROCHLORIDE |
NOSTRUM PHARMS LLC |
Labeling |
Approval |
11/05/2019 |
CYRAMZA BLA #125477 |
SUPPL-35 |
RAMUCIRUMAB |
ELI LILLY AND CO |
|
Approval |
11/05/2019 |
MONTELUKAST SODIUM ANDA #202096 |
SUPPL-18 |
MONTELUKAST SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/05/2019 |
MONTELUKAST SODIUM ANDA #202096 |
SUPPL-21 |
MONTELUKAST SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/05/2019 |
KORLYM NDA #202107 |
SUPPL-8 |
MIFEPRISTONE |
CORCEPT THERAP |
Labeling |
Approval |
11/05/2019 |
MONTELUKAST SODIUM ANDA #202468 |
SUPPL-20 |
MONTELUKAST SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/05/2019 |
MONTELUKAST SODIUM ANDA #202468 |
SUPPL-23 |
MONTELUKAST SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/05/2019 |
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE ANDA #203040 |
SUPPL-4 |
LIDOCAINE HYDROCHLORIDE |
EUGIA PHARMA |
Labeling |
Approval |
11/05/2019 |
TELMISARTAN ANDA #204415 |
SUPPL-3 |
TELMISARTAN |
AMNEAL PHARMS |
Labeling |
Approval |
11/05/2019 |
METFORMIN HYDROCHLORIDE ANDA #205330 |
SUPPL-4 |
METFORMIN HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/05/2019 |
METRONIDAZOLE IN PLASTIC CONTAINER ANDA #205531 |
SUPPL-1 |
METRONIDAZOLE |
RISING |
Labeling |
Approval |
11/05/2019 |
METFORMIN HYDROCHLORIDE ANDA #206955 |
SUPPL-3 |
METFORMIN HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/05/2019 |
METFORMIN HYDROCHLORIDE ANDA #206955 |
SUPPL-10 |
METFORMIN HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/05/2019 |
ERLOTINIB HYDROCHLORIDE ANDA #208396 |
ORIG-1 |
ERLOTINIB HYDROCHLORIDE |
APOTEX |
|
Approval |
11/05/2019 |
ERLOTINIB HYDROCHLORIDE ANDA #208488 |
ORIG-1 |
ERLOTINIB HYDROCHLORIDE |
NATCO PHARMA LTD |
|
Approval |
11/05/2019 |
EPINEPHRINE NDA #209359 |
ORIG-1 |
EPINEPHRINE |
HOSPIRA |
Type 7 - Drug Already Marketed without Approved NDA |
Approval |
11/05/2019 |
ERLOTINIB HYDROCHLORIDE ANDA #210300 |
ORIG-1 |
ERLOTINIB HYDROCHLORIDE |
SUN PHARM |
|
Approval |
11/05/2019 |
ABSORICA LD NDA #211913 |
ORIG-1 |
ISOTRETINOIN |
SUN PHARM |
New Combination and New Formulation or New Manufacturer |
Approval |
11/05/2019 |
ERLOTINIB HYDROCHLORIDE ANDA #211960 |
ORIG-1 |
ERLOTINIB HYDROCHLORIDE |
SHILPA |
|
Approval |
11/05/2019 |
ZILEUTON ANDA #211972 |
ORIG-1 |
ZILEUTON |
LUPIN LTD |
|
Approval |
11/06/2019 |
BARACLUDE NDA #021797 |
SUPPL-23 |
ENTECAVIR |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
11/06/2019 |
BARACLUDE NDA #021798 |
SUPPL-24 |
ENTECAVIR |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
11/06/2019 |
VPRIV BLA #022575 |
SUPPL-23 |
VELAGLUCERASE ALFA |
SHIRE HUMAN GENETIC |
|
Approval |
11/06/2019 |
MOXATAG NDA #050813 |
SUPPL-8 |
AMOXICILLIN |
PRAGMA |
Labeling |
Approval |
11/06/2019 |
NAPROXEN ANDA #075227 |
SUPPL-17 |
NAPROXEN |
TEVA |
Labeling |
Approval |
11/06/2019 |
NAPROXEN ANDA #075227 |
SUPPL-18 |
NAPROXEN |
TEVA |
Labeling |
Approval |
11/06/2019 |
NAPROXEN ANDA #075227 |
SUPPL-20 |
NAPROXEN |
TEVA |
Labeling |
Approval |
11/06/2019 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE ANDA #076374 |
SUPPL-10 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
11/06/2019 |
QUINAPRIL HYDROCHLORIDE ANDA #078457 |
SUPPL-11 |
QUINAPRIL HYDROCHLORIDE |
INVAGEN PHARMS |
Labeling |
Approval |
11/06/2019 |
FOSPHENYTOIN SODIUM ANDA #078736 |
SUPPL-5 |
FOSPHENYTOIN SODIUM |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
11/06/2019 |
FOSPHENYTOIN SODIUM ANDA #078736 |
SUPPL-8 |
FOSPHENYTOIN SODIUM |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
11/06/2019 |
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE ANDA #086513 |
SUPPL-76 |
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE |
MYLAN |
Labeling |
Approval |
11/06/2019 |
CLOPIDOGREL BISULFATE ANDA #090844 |
SUPPL-8 |
CLOPIDOGREL BISULFATE |
TORRENT PHARMS LTD |
Labeling |
Approval |
11/06/2019 |
CLOPIDOGREL BISULFATE ANDA #090844 |
SUPPL-9 |
CLOPIDOGREL BISULFATE |
TORRENT PHARMS LTD |
Labeling |
Approval |
11/06/2019 |
CLOPIDOGREL BISULFATE ANDA #090844 |
SUPPL-10 |
CLOPIDOGREL BISULFATE |
TORRENT PHARMS LTD |
Labeling |
Approval |
11/06/2019 |
CLOPIDOGREL BISULFATE ANDA #090844 |
SUPPL-12 |
CLOPIDOGREL BISULFATE |
TORRENT PHARMS LTD |
Labeling |
Approval |
11/06/2019 |
NAPROXEN SODIUM ANDA #091353 |
SUPPL-15 |
NAPROXEN SODIUM |
GRANULES INDIA |
Manufacturing (CMC) |
Approval |
11/06/2019 |
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM ANDA #200465 |
SUPPL-6 |
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM |
MYLAN |
Labeling |
Approval |
11/06/2019 |
TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #201192 |
SUPPL-6 |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
TORRENT |
Labeling |
Approval |
11/06/2019 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE ANDA #201356 |
SUPPL-11 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
INVAGEN PHARMS |
Labeling |
Approval |
11/06/2019 |
GUANFACINE HYDROCHLORIDE ANDA #201382 |
SUPPL-3 |
GUANFACINE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
11/06/2019 |
GUANFACINE HYDROCHLORIDE ANDA #201382 |
SUPPL-4 |
GUANFACINE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
11/06/2019 |
GUANFACINE HYDROCHLORIDE ANDA #201382 |
SUPPL-5 |
GUANFACINE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
11/06/2019 |
GUANFACINE HYDROCHLORIDE ANDA #201382 |
SUPPL-6 |
GUANFACINE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
11/06/2019 |
FOLIC ACID ANDA #202522 |
ORIG-1 |
FOLIC ACID |
XGEN PHARMS |
|
Approval |
11/06/2019 |
IRBESARTAN ANDA #202910 |
SUPPL-10 |
IRBESARTAN |
HETERO LABS LTD V |
Labeling |
Approval |
11/06/2019 |
TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #203010 |
SUPPL-11 |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
ALEMBIC |
Labeling |
Approval |
11/06/2019 |
VALSARTAN ANDA #203311 |
SUPPL-3 |
VALSARTAN |
HETERO LABS LTD V |
Labeling |
Approval |
11/06/2019 |
VALSARTAN ANDA #203311 |
SUPPL-5 |
VALSARTAN |
HETERO LABS LTD V |
Labeling |
Approval |
11/06/2019 |
VALSARTAN ANDA #203311 |
SUPPL-9 |
VALSARTAN |
HETERO LABS LTD V |
Labeling |
Approval |
11/06/2019 |
TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #204169 |
SUPPL-7 |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/06/2019 |
TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #204221 |
SUPPL-1 |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
ZYDUS PHARMS |
Labeling |
Approval |
11/06/2019 |
VALSARTAN ANDA #205536 |
SUPPL-2 |
VALSARTAN |
ALKEM LABS LTD |
Labeling |
Approval |
11/06/2019 |
AMBRISENTAN ANDA #208441 |
SUPPL-1 |
AMBRISENTAN |
MYLAN |
Labeling |
Approval |
11/06/2019 |
BOSENTAN ANDA #208695 |
SUPPL-2 |
BOSENTAN |
HIKMA |
Labeling |
Approval |
11/06/2019 |
ALOSETRON HYDROCHLORIDE ANDA #209180 |
SUPPL-1 |
ALOSETRON HYDROCHLORIDE |
RISING |
Labeling |
Approval |
11/06/2019 |
DIAZEPAM ANDA #210363 |
SUPPL-1 |
DIAZEPAM |
BELOTECA |
Labeling |
Approval |
11/06/2019 |
AMBRISENTAN ANDA #210715 |
SUPPL-1 |
AMBRISENTAN |
CIPLA |
Labeling |
Approval |
11/06/2019 |
AMBRISENTAN ANDA #210784 |
SUPPL-1 |
AMBRISENTAN |
SUN PHARM |
Labeling |
Approval |
11/07/2019 |
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #019950 |
SUPPL-66 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
11/07/2019 |
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #019950 |
SUPPL-67 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
11/07/2019 |
DIFLUCAN IN SODIUM CHLORIDE 0.9% NDA #019950 |
SUPPL-66 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
11/07/2019 |
DIFLUCAN IN SODIUM CHLORIDE 0.9% NDA #019950 |
SUPPL-67 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
11/07/2019 |
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #019950 |
SUPPL-66 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
11/07/2019 |
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #019950 |
SUPPL-67 |
FLUCONAZOLE |
PFIZER |
Labeling |
Approval |
11/07/2019 |
HYZAAR NDA #020387 |
SUPPL-64 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
ORGANON |
Labeling |
Approval |
11/07/2019 |
CHILDREN'S CLARITIN NDA #021891 |
SUPPL-32 |
LORATADINE |
BAYER HEALTHCARE LLC |
Manufacturing (CMC) |
Approval |
11/07/2019 |
CLARITIN NDA #021891 |
SUPPL-32 |
LORATADINE |
BAYER HEALTHCARE LLC |
Manufacturing (CMC) |
Approval |
11/07/2019 |
ABSORICA NDA #021951 |
SUPPL-13 |
ISOTRETINOIN |
SUN PHARM INDS INC |
Labeling |
Approval |
11/07/2019 |
ALLOPURINOL ANDA #075798 |
SUPPL-21 |
ALLOPURINOL |
ENDO OPERATIONS |
Labeling |
Approval |
11/07/2019 |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE ANDA #077483 |
SUPPL-9 |
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
11/07/2019 |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE ANDA #077483 |
SUPPL-10 |
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
11/07/2019 |
MONTELUKAST SODIUM ANDA #090926 |
SUPPL-4 |
MONTELUKAST SODIUM |
GLENMARK PHARMS LTD |
Labeling |
Approval |
11/07/2019 |
MONTELUKAST SODIUM ANDA #090926 |
SUPPL-6 |
MONTELUKAST SODIUM |
GLENMARK PHARMS LTD |
Labeling |
Approval |
11/07/2019 |
MONTELUKAST SODIUM ANDA #090926 |
SUPPL-8 |
MONTELUKAST SODIUM |
GLENMARK PHARMS LTD |
Labeling |
Approval |
11/07/2019 |
MONTELUKAST SODIUM ANDA #090926 |
SUPPL-11 |
MONTELUKAST SODIUM |
GLENMARK PHARMS LTD |
Labeling |
Approval |
11/07/2019 |
ESZOPICLONE ANDA #091169 |
SUPPL-3 |
ESZOPICLONE |
TEVA |
Labeling |
Approval |
11/07/2019 |
ESZOPICLONE ANDA #091169 |
SUPPL-7 |
ESZOPICLONE |
TEVA |
Labeling |
Approval |
11/07/2019 |
ESZOPICLONE ANDA #091169 |
SUPPL-8 |
ESZOPICLONE |
TEVA |
Labeling |
Approval |
11/07/2019 |
ESZOPICLONE ANDA #091169 |
SUPPL-10 |
ESZOPICLONE |
TEVA |
Labeling |
Approval |
11/07/2019 |
STELARA BLA #125261 |
SUPPL-142 |
USTEKINUMAB |
CENTOCOR ORTHO BIOTECH INC |
|
Approval |
11/07/2019 |
MONTELUKAST SODIUM ANDA #202717 |
SUPPL-14 |
MONTELUKAST SODIUM |
ACCORD HLTHCARE |
Labeling |
Approval |
11/07/2019 |
MONTELUKAST SODIUM ANDA #202717 |
SUPPL-15 |
MONTELUKAST SODIUM |
ACCORD HLTHCARE |
Labeling |
Approval |
11/07/2019 |
MONTELUKAST SODIUM ANDA #202906 |
SUPPL-6 |
MONTELUKAST SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/07/2019 |
MONTELUKAST SODIUM ANDA #202906 |
SUPPL-7 |
MONTELUKAST SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/07/2019 |
MONTELUKAST SODIUM ANDA #202906 |
SUPPL-10 |
MONTELUKAST SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/07/2019 |
MONTELUKAST SODIUM ANDA #202906 |
SUPPL-11 |
MONTELUKAST SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/07/2019 |
MONTELUKAST SODIUM ANDA #202906 |
SUPPL-12 |
MONTELUKAST SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/07/2019 |
ZONTIVITY NDA #204886 |
SUPPL-5 |
VORAPAXAR SULFATE |
KEY THERAP |
Labeling |
Approval |
11/07/2019 |
ATORVASTATIN CALCIUM ANDA #205945 |
ORIG-1 |
ATORVASTATIN CALCIUM |
MICRO LABS LTD INDIA |
|
Approval |
11/07/2019 |
ATOVAQUONE ANDA #207833 |
SUPPL-1 |
ATOVAQUONE |
CHARTWELL RX |
Labeling |
Approval |
11/07/2019 |
ATOVAQUONE ANDA #207833 |
SUPPL-2 |
ATOVAQUONE |
CHARTWELL RX |
Labeling |
Approval |
11/07/2019 |
BENZNIDAZOLE NDA #209570 |
SUPPL-1 |
BENZNIDAZOLE |
CHEMO RESEARCH SL |
Labeling |
Approval |
11/07/2019 |
EXEM FOAM KIT NDA #212279 |
ORIG-1 |
AIR POLYMER-TYPE A |
GISKIT |
Type 1 - New Molecular Entity |
Approval |
11/07/2019 |
STELARA BLA #761044 |
SUPPL-1 |
USTEKINUMAB |
JANSSEN BIOTECH |
|
Approval |
11/08/2019 |
PROVOCHOLINE NDA #019193 |
SUPPL-21 |
METHACHOLINE CHLORIDE |
METHAPHARM |
Efficacy |
Approval |
11/08/2019 |
SUPPRELIN LA NDA #022058 |
SUPPL-16 |
HISTRELIN ACETATE |
ENDO OPERATIONS |
Labeling |
Approval |
11/08/2019 |
FAMOTIDINE ANDA #075610 |
SUPPL-9 |
FAMOTIDINE |
APOTEX |
Labeling |
Approval |
11/08/2019 |
FAMOTIDINE ANDA #075610 |
SUPPL-10 |
FAMOTIDINE |
APOTEX |
Labeling |
Approval |
11/08/2019 |
METFORMIN HYDROCHLORIDE ANDA #076873 |
SUPPL-8 |
METFORMIN HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
11/08/2019 |
METFORMIN HYDROCHLORIDE ANDA #076873 |
SUPPL-9 |
METFORMIN HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
11/08/2019 |
FAMOTIDINE ANDA #077367 |
SUPPL-17 |
FAMOTIDINE |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/08/2019 |
METRONIDAZOLE IN PLASTIC CONTAINER ANDA #078084 |
SUPPL-11 |
METRONIDAZOLE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/08/2019 |
METRONIDAZOLE IN PLASTIC CONTAINER ANDA #078084 |
SUPPL-14 |
METRONIDAZOLE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/08/2019 |
MONTELUKAST SODIUM ANDA #090955 |
SUPPL-10 |
MONTELUKAST SODIUM |
TEVA PHARMS |
Labeling |
Approval |
11/08/2019 |
MONTELUKAST SODIUM ANDA #090955 |
SUPPL-12 |
MONTELUKAST SODIUM |
TEVA PHARMS |
Labeling |
Approval |
11/08/2019 |
MONTELUKAST SODIUM ANDA #090955 |
SUPPL-13 |
MONTELUKAST SODIUM |
TEVA PHARMS |
Labeling |
Approval |
11/08/2019 |
MONTELUKAST SODIUM ANDA #203328 |
SUPPL-1 |
MONTELUKAST SODIUM |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/08/2019 |
MONTELUKAST SODIUM ANDA #203328 |
SUPPL-7 |
MONTELUKAST SODIUM |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/08/2019 |
MONTELUKAST SODIUM ANDA #203328 |
SUPPL-8 |
MONTELUKAST SODIUM |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/08/2019 |
MONTELUKAST SODIUM ANDA #203366 |
SUPPL-13 |
MONTELUKAST SODIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/08/2019 |
MONTELUKAST SODIUM ANDA #203366 |
SUPPL-16 |
MONTELUKAST SODIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/08/2019 |
MONTELUKAST SODIUM ANDA #203432 |
SUPPL-1 |
MONTELUKAST SODIUM |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/08/2019 |
MONTELUKAST SODIUM ANDA #203432 |
SUPPL-5 |
MONTELUKAST SODIUM |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/08/2019 |
MONTELUKAST SODIUM ANDA #203432 |
SUPPL-7 |
MONTELUKAST SODIUM |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/08/2019 |
MONTELUKAST SODIUM ANDA #203438 |
SUPPL-1 |
MONTELUKAST SODIUM |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/08/2019 |
MONTELUKAST SODIUM ANDA #203438 |
SUPPL-6 |
MONTELUKAST SODIUM |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/08/2019 |
MONTELUKAST SODIUM ANDA #203438 |
SUPPL-10 |
MONTELUKAST SODIUM |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/08/2019 |
DORZOLAMIDE HYDROCHLORIDE ANDA #204778 |
ORIG-1 |
DORZOLAMIDE HYDROCHLORIDE |
MICRO LABS |
|
Approval |
11/08/2019 |
PROPOFOL ANDA #205307 |
SUPPL-1 |
PROPOFOL |
WATSON LABS INC |
Labeling |
Approval |
11/08/2019 |
ADAPALENE AND BENZOYL PEROXIDE ANDA #208108 |
ORIG-1 |
ADAPALENE; BENZOYL PEROXIDE |
GLENMARK PHARMS LTD |
|
Approval |
11/08/2019 |
BENDEKA NDA #208194 |
SUPPL-20 |
BENDAMUSTINE HYDROCHLORIDE |
EAGLE PHARMS |
Labeling |
Approval |
11/08/2019 |
REBLOZYL BLA #761136 |
ORIG-1 |
LUSPATERCEPT-AAMT |
CELGENE CORP |
|
Approval |
11/12/2019 |
INDOMETHACIN ANDA #070673 |
SUPPL-20 |
INDOMETHACIN |
SANDOZ |
Labeling |
Approval |
11/12/2019 |
INDOMETHACIN ANDA #070673 |
SUPPL-21 |
INDOMETHACIN |
SANDOZ |
Labeling |
Approval |
11/12/2019 |
INDOMETHACIN ANDA #070674 |
SUPPL-20 |
INDOMETHACIN |
SANDOZ |
Labeling |
Approval |
11/12/2019 |
INDOMETHACIN ANDA #070674 |
SUPPL-21 |
INDOMETHACIN |
SANDOZ |
Labeling |
Approval |
11/12/2019 |
IBUPROFEN ANDA #078682 |
SUPPL-20 |
IBUPROFEN |
BIONPHARMA |
Manufacturing (CMC) |
Approval |
11/12/2019 |
RISPERIDONE ANDA #078871 |
SUPPL-5 |
RISPERIDONE |
NOVITIUM PHARMA |
Labeling |
Approval |
11/12/2019 |
RISPERIDONE ANDA #078871 |
SUPPL-6 |
RISPERIDONE |
NOVITIUM PHARMA |
Labeling |
Approval |
11/12/2019 |
RISPERIDONE ANDA #078871 |
SUPPL-7 |
RISPERIDONE |
NOVITIUM PHARMA |
Labeling |
Approval |
11/12/2019 |
DAPTOMYCIN ANDA #091039 |
SUPPL-2 |
DAPTOMYCIN |
TEVA PHARMS USA |
Labeling |
Approval |
11/12/2019 |
DAPTOMYCIN ANDA #091039 |
SUPPL-3 |
DAPTOMYCIN |
TEVA PHARMS USA |
Labeling |
Approval |
11/12/2019 |
DAPTOMYCIN ANDA #091039 |
SUPPL-4 |
DAPTOMYCIN |
TEVA PHARMS USA |
Labeling |
Approval |
11/12/2019 |
ESZOPICLONE ANDA #091166 |
SUPPL-4 |
ESZOPICLONE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
11/12/2019 |
ESZOPICLONE ANDA #091166 |
SUPPL-5 |
ESZOPICLONE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
11/12/2019 |
ESZOPICLONE ANDA #091166 |
SUPPL-6 |
ESZOPICLONE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
11/12/2019 |
RISPERIDONE ANDA #201003 |
SUPPL-10 |
RISPERIDONE |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/12/2019 |
RISPERIDONE ANDA #201003 |
SUPPL-14 |
RISPERIDONE |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/12/2019 |
RISPERIDONE ANDA #201003 |
SUPPL-16 |
RISPERIDONE |
AJANTA PHARMA LTD |
Labeling |
Approval |
11/12/2019 |
ITRACONAZOLE ANDA #205724 |
SUPPL-1 |
ITRACONAZOLE |
RISING |
Labeling |
Approval |
11/12/2019 |
ITRACONAZOLE ANDA #205724 |
SUPPL-2 |
ITRACONAZOLE |
RISING |
Labeling |
Approval |
11/12/2019 |
ITRACONAZOLE ANDA #205724 |
SUPPL-4 |
ITRACONAZOLE |
RISING |
Labeling |
Approval |
11/13/2019 |
PROPAFENONE HYDROCHLORIDE ANDA #075203 |
SUPPL-17 |
PROPAFENONE HYDROCHLORIDE |
WATSON LABS |
Labeling |
Approval |
11/13/2019 |
MIDODRINE HYDROCHLORIDE ANDA #076449 |
SUPPL-14 |
MIDODRINE HYDROCHLORIDE |
IMPAX PHARMS |
Labeling |
Approval |
11/13/2019 |
ORVATEN ANDA #076725 |
SUPPL-17 |
MIDODRINE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
11/13/2019 |
MIDODRINE HYDROCHLORIDE ANDA #077746 |
SUPPL-7 |
MIDODRINE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
11/13/2019 |
MELOXICAM ANDA #077938 |
SUPPL-4 |
MELOXICAM |
PURACAP PHARM |
Labeling |
Approval |
11/13/2019 |
PROCAINAMIDE HYDROCHLORIDE ANDA #088636 |
SUPPL-15 |
PROCAINAMIDE HYDROCHLORIDE |
INTL MEDICATION |
Labeling |
Approval |
11/13/2019 |
PANTOPRAZOLE SODIUM ANDA #090807 |
SUPPL-5 |
PANTOPRAZOLE SODIUM |
RUBICON |
Labeling |
Approval |
11/13/2019 |
PANTOPRAZOLE SODIUM ANDA #090807 |
SUPPL-6 |
PANTOPRAZOLE SODIUM |
RUBICON |
Labeling |
Approval |
11/13/2019 |
PANTOPRAZOLE SODIUM ANDA #090807 |
SUPPL-7 |
PANTOPRAZOLE SODIUM |
RUBICON |
Labeling |
Approval |
11/13/2019 |
PANTOPRAZOLE SODIUM ANDA #090807 |
SUPPL-8 |
PANTOPRAZOLE SODIUM |
RUBICON |
Labeling |
Approval |
11/13/2019 |
PANTOPRAZOLE SODIUM ANDA #090807 |
SUPPL-9 |
PANTOPRAZOLE SODIUM |
RUBICON |
Labeling |
Approval |
11/13/2019 |
PROPAFENONE HYDROCHLORIDE ANDA #202445 |
SUPPL-1 |
PROPAFENONE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/13/2019 |
LUMASON NDA #203684 |
SUPPL-5 |
SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES |
BRACCO |
Efficacy |
Approval |
11/13/2019 |
MIDAZOLAM HYDROCHLORIDE ANDA #208878 |
SUPPL-1 |
MIDAZOLAM HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
11/14/2019 |
EMEND NDA #021549 |
SUPPL-30 |
APREPITANT |
MERCK |
Labeling |
Approval |
11/14/2019 |
EMEND NDA #022023 |
SUPPL-19 |
FOSAPREPITANT DIMEGLUMINE |
MERCK AND CO INC |
Labeling |
Approval |
11/14/2019 |
OXYCONTIN NDA #022272 |
SUPPL-42 |
OXYCODONE HYDROCHLORIDE |
PURDUE PHARMA LP |
REMS |
Approval |
11/14/2019 |
SPIRONOLACTONE ANDA #040424 |
SUPPL-21 |
SPIRONOLACTONE |
MYLAN |
Labeling |
Approval |
11/14/2019 |
DIFLORASONE DIACETATE ANDA #075374 |
SUPPL-11 |
DIFLORASONE DIACETATE |
AVONDALE PHARMS |
Labeling |
Approval |
11/14/2019 |
DIFLORASONE DIACETATE ANDA #075374 |
SUPPL-12 |
DIFLORASONE DIACETATE |
AVONDALE PHARMS |
Labeling |
Approval |
11/14/2019 |
CLOBETASOL PROPIONATE (EMOLLIENT) ANDA #075633 |
SUPPL-10 |
CLOBETASOL PROPIONATE |
TARO |
Labeling |
Approval |
11/14/2019 |
METFORMIN HYDROCHLORIDE ANDA #075969 |
SUPPL-11 |
METFORMIN HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
11/14/2019 |
METFORMIN HYDROCHLORIDE ANDA #075969 |
SUPPL-12 |
METFORMIN HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
11/14/2019 |
METFORMIN HYDROCHLORIDE ANDA #075976 |
SUPPL-20 |
METFORMIN HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
11/14/2019 |
METFORMIN HYDROCHLORIDE ANDA #075976 |
SUPPL-21 |
METFORMIN HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
11/14/2019 |
METFORMIN HYDROCHLORIDE ANDA #076650 |
SUPPL-7 |
METFORMIN HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
11/14/2019 |
METFORMIN HYDROCHLORIDE ANDA #076650 |
SUPPL-8 |
METFORMIN HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
11/14/2019 |
METFORMIN HYDROCHLORIDE ANDA #077113 |
SUPPL-8 |
METFORMIN HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
11/14/2019 |
METFORMIN HYDROCHLORIDE ANDA #077113 |
SUPPL-9 |
METFORMIN HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
11/14/2019 |
FLUTICASONE PROPIONATE ANDA #077570 |
SUPPL-13 |
FLUTICASONE PROPIONATE |
HIKMA |
Labeling |
Approval |
11/14/2019 |
PANTOPRAZOLE SODIUM ANDA #077619 |
SUPPL-11 |
PANTOPRAZOLE SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/14/2019 |
PANTOPRAZOLE SODIUM ANDA #077619 |
SUPPL-12 |
PANTOPRAZOLE SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/14/2019 |
PANTOPRAZOLE SODIUM ANDA #077619 |
SUPPL-13 |
PANTOPRAZOLE SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/14/2019 |
PANTOPRAZOLE SODIUM ANDA #077619 |
SUPPL-14 |
PANTOPRAZOLE SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/14/2019 |
PANTOPRAZOLE SODIUM ANDA #077619 |
SUPPL-15 |
PANTOPRAZOLE SODIUM |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/14/2019 |
CLOBETASOL PROPIONATE ANDA #077763 |
SUPPL-11 |
CLOBETASOL PROPIONATE |
PADAGIS ISRAEL |
Labeling |
Approval |
11/14/2019 |
CLOBETASOL PROPIONATE ANDA #077763 |
SUPPL-13 |
CLOBETASOL PROPIONATE |
PADAGIS ISRAEL |
Labeling |
Approval |
11/14/2019 |
TEMOZOLOMIDE ANDA #078879 |
SUPPL-15 |
TEMOZOLOMIDE |
HERITAGE |
Labeling |
Approval |
11/14/2019 |
PANTOPRAZOLE SODIUM ANDA #090074 |
SUPPL-16 |
PANTOPRAZOLE SODIUM |
TORRENT PHARMS |
Labeling |
Approval |
11/14/2019 |
PANTOPRAZOLE SODIUM ANDA #090074 |
SUPPL-18 |
PANTOPRAZOLE SODIUM |
TORRENT PHARMS |
Labeling |
Approval |
11/14/2019 |
PANTOPRAZOLE SODIUM ANDA #090074 |
SUPPL-19 |
PANTOPRAZOLE SODIUM |
TORRENT PHARMS |
Labeling |
Approval |
11/14/2019 |
PANTOPRAZOLE SODIUM ANDA #090074 |
SUPPL-22 |
PANTOPRAZOLE SODIUM |
TORRENT PHARMS |
Labeling |
Approval |
11/14/2019 |
DIDANOSINE ANDA #090094 |
SUPPL-13 |
DIDANOSINE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/14/2019 |
DIDANOSINE ANDA #090094 |
SUPPL-14 |
DIDANOSINE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/14/2019 |
FLUTICASONE PROPIONATE ANDA #090759 |
SUPPL-3 |
FLUTICASONE PROPIONATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
11/14/2019 |
FLUTICASONE PROPIONATE ANDA #090759 |
SUPPL-5 |
FLUTICASONE PROPIONATE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
11/14/2019 |
QUETIAPINE FUMARATE ANDA #090960 |
SUPPL-10 |
QUETIAPINE FUMARATE |
ZENNOVA |
Labeling |
Approval |
11/14/2019 |
QUETIAPINE FUMARATE ANDA #090960 |
SUPPL-11 |
QUETIAPINE FUMARATE |
ZENNOVA |
Labeling |
Approval |
11/14/2019 |
METHAMPHETAMINE HYDROCHLORIDE ANDA #091189 |
SUPPL-4 |
METHAMPHETAMINE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
11/14/2019 |
METHAMPHETAMINE HYDROCHLORIDE ANDA #091189 |
SUPPL-5 |
METHAMPHETAMINE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
11/14/2019 |
METHAMPHETAMINE HYDROCHLORIDE ANDA #091189 |
SUPPL-6 |
METHAMPHETAMINE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
11/14/2019 |
WARFARIN SODIUM ANDA #200104 |
SUPPL-1 |
WARFARIN SODIUM |
IPCA LABS LTD |
Labeling |
Approval |
11/14/2019 |
WARFARIN SODIUM ANDA #200104 |
SUPPL-2 |
WARFARIN SODIUM |
IPCA LABS LTD |
Labeling |
Approval |
11/14/2019 |
WARFARIN SODIUM ANDA #200104 |
SUPPL-4 |
WARFARIN SODIUM |
IPCA LABS LTD |
Labeling |
Approval |
11/14/2019 |
WARFARIN SODIUM ANDA #200104 |
SUPPL-5 |
WARFARIN SODIUM |
IPCA LABS LTD |
Labeling |
Approval |
11/14/2019 |
PANTOPRAZOLE SODIUM ANDA #202038 |
SUPPL-10 |
PANTOPRAZOLE SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/14/2019 |
PANTOPRAZOLE SODIUM ANDA #202038 |
SUPPL-12 |
PANTOPRAZOLE SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/14/2019 |
PANTOPRAZOLE SODIUM ANDA #202038 |
SUPPL-13 |
PANTOPRAZOLE SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/14/2019 |
PANTOPRAZOLE SODIUM ANDA #202038 |
SUPPL-15 |
PANTOPRAZOLE SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/14/2019 |
PANTOPRAZOLE SODIUM ANDA #202038 |
SUPPL-18 |
PANTOPRAZOLE SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/14/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #202063 |
SUPPL-7 |
GEMCITABINE HYDROCHLORIDE |
EMCURE PHARMS LTD |
Labeling |
Approval |
11/14/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #202063 |
SUPPL-8 |
GEMCITABINE HYDROCHLORIDE |
EMCURE PHARMS LTD |
Labeling |
Approval |
11/14/2019 |
GEMCITABINE HYDROCHLORIDE ANDA #202063 |
SUPPL-9 |
GEMCITABINE HYDROCHLORIDE |
EMCURE PHARMS LTD |
Labeling |
Approval |
11/14/2019 |
FUROSEMIDE ANDA #202747 |
SUPPL-3 |
FUROSEMIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/14/2019 |
SPIRONOLACTONE ANDA #203253 |
SUPPL-5 |
SPIRONOLACTONE |
JUBILANT GENERICS |
Labeling |
Approval |
11/14/2019 |
DOXERCALCIFEROL ANDA #203875 |
ORIG-1 |
DOXERCALCIFEROL |
SUN PHARM |
|
Approval |
11/14/2019 |
PROPAFENONE HYDROCHLORIDE ANDA #205956 |
SUPPL-3 |
PROPAFENONE HYDROCHLORIDE |
RISING |
Labeling |
Approval |
11/14/2019 |
ROPIVACAINE HYDROCHLORIDE ANDA #206166 |
SUPPL-3 |
ROPIVACAINE HYDROCHLORIDE |
INFORLIFE |
Labeling |
Approval |
11/14/2019 |
HYSINGLA ER NDA #206627 |
SUPPL-9 |
HYDROCODONE BITARTRATE |
PURDUE PHARMA LP |
REMS |
Approval |
11/14/2019 |
EMEND NDA #207865 |
SUPPL-3 |
APREPITANT |
MSD MERCK CO |
Labeling |
Approval |
11/14/2019 |
MIGLUSTAT ANDA #208342 |
SUPPL-1 |
MIGLUSTAT |
ANI PHARMS |
Labeling |
Approval |
11/14/2019 |
CELECOXIB ANDA #208701 |
ORIG-1 |
CELECOXIB |
CADILA PHARMS LTD |
|
Approval |
11/14/2019 |
METFORMIN HYDROCHLORIDE ANDA #209303 |
SUPPL-2 |
METFORMIN HYDROCHLORIDE |
ALIGNSCIENCE PHARMA |
Labeling |
Approval |
11/14/2019 |
FETROJA NDA #209445 |
ORIG-1 |
CEFIDEROCOL SULFATE TOSYLATE |
SHIONOGI INC |
Type 1 - New Molecular Entity |
Approval |
11/14/2019 |
BUSPIRONE HYDROCHLORIDE ANDA #210907 |
ORIG-1 |
BUSPIRONE HYDROCHLORIDE |
UNICHEM |
|
Approval |
11/14/2019 |
COLCHICINE ANDA #211519 |
SUPPL-1 |
COLCHICINE |
ZYDUS PHARMS |
Manufacturing (CMC) |
Approval |
11/14/2019 |
BRUKINSA NDA #213217 |
ORIG-1 |
ZANUBRUTINIB |
BEIGENE |
Type 1 - New Molecular Entity |
Approval |
11/15/2019 |
HUMULIN R BLA #018780 |
SUPPL-175 |
INSULIN HUMAN |
LILLY |
|
Approval |
11/15/2019 |
HUMULIN R BLA #018780 |
SUPPL-176 |
INSULIN HUMAN |
LILLY |
|
Approval |
11/15/2019 |
HUMULIN R BLA #018780 |
SUPPL-175 |
INSULIN RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/15/2019 |
HUMULIN R BLA #018780 |
SUPPL-176 |
INSULIN RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/15/2019 |
HUMULIN R KWIKPEN BLA #018780 |
SUPPL-175 |
INSULIN HUMAN |
LILLY |
|
Approval |
11/15/2019 |
HUMULIN R KWIKPEN BLA #018780 |
SUPPL-176 |
INSULIN HUMAN |
LILLY |
|
Approval |
11/15/2019 |
HUMULIN R PEN BLA #018780 |
SUPPL-175 |
INSULIN RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/15/2019 |
HUMULIN R PEN BLA #018780 |
SUPPL-176 |
INSULIN RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/15/2019 |
HUMULIN N BLA #018781 |
SUPPL-187 |
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/15/2019 |
HUMULIN N BLA #018781 |
SUPPL-188 |
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/15/2019 |
HUMULIN 70/30 BLA #019717 |
SUPPL-168 |
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/15/2019 |
HUMULIN 70/30 BLA #019717 |
SUPPL-169 |
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/15/2019 |
HUMULIN 70/30 PEN BLA #019717 |
SUPPL-168 |
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/15/2019 |
HUMULIN 70/30 PEN BLA #019717 |
SUPPL-169 |
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/15/2019 |
NOVOLIN R BLA #019938 |
SUPPL-79 |
INSULIN RECOMBINANT HUMAN |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLIN N BLA #019959 |
SUPPL-82 |
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLIN 70/30 BLA #019991 |
SUPPL-82 |
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NICORETTE NDA #020066 |
SUPPL-64 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
11/15/2019 |
NICORETTE (MINT) NDA #020066 |
SUPPL-64 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
11/15/2019 |
HUMALOG BLA #020563 |
SUPPL-196 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG BLA #020563 |
SUPPL-198 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG BLA #020563 |
SUPPL-199 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG KWIKPEN BLA #020563 |
SUPPL-196 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG KWIKPEN BLA #020563 |
SUPPL-198 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG KWIKPEN BLA #020563 |
SUPPL-199 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG PEN BLA #020563 |
SUPPL-196 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG PEN BLA #020563 |
SUPPL-198 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG PEN BLA #020563 |
SUPPL-199 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG TEMPO PEN BLA #020563 |
SUPPL-196 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG TEMPO PEN BLA #020563 |
SUPPL-198 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG TEMPO PEN BLA #020563 |
SUPPL-199 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
NOVOLOG BLA #020986 |
SUPPL-90 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG BLA #020986 |
SUPPL-91 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG FLEXPEN BLA #020986 |
SUPPL-90 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG FLEXPEN BLA #020986 |
SUPPL-91 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG FLEXTOUCH BLA #020986 |
SUPPL-90 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG FLEXTOUCH BLA #020986 |
SUPPL-91 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG INNOLET BLA #020986 |
SUPPL-90 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG INNOLET BLA #020986 |
SUPPL-91 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG PENFILL BLA #020986 |
SUPPL-90 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG PENFILL BLA #020986 |
SUPPL-91 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
HUMALOG MIX 75/25 BLA #021017 |
SUPPL-141 |
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG MIX 75/25 BLA #021017 |
SUPPL-143 |
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG MIX 75/25 KWIKPEN BLA #021017 |
SUPPL-141 |
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG MIX 75/25 KWIKPEN BLA #021017 |
SUPPL-143 |
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG MIX 75/25 PEN BLA #021017 |
SUPPL-141 |
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG MIX 75/25 PEN BLA #021017 |
SUPPL-143 |
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG MIX 50/50 BLA #021018 |
SUPPL-127 |
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG MIX 50/50 BLA #021018 |
SUPPL-129 |
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG MIX 50/50 KWIKPEN BLA #021018 |
SUPPL-127 |
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG MIX 50/50 KWIKPEN BLA #021018 |
SUPPL-129 |
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG MIX 50/50 PEN BLA #021018 |
SUPPL-127 |
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
HUMALOG MIX 50/50 PEN BLA #021018 |
SUPPL-129 |
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/15/2019 |
LANTUS BLA #021081 |
SUPPL-73 |
INSULIN GLARGINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
11/15/2019 |
LANTUS BLA #021081 |
SUPPL-74 |
INSULIN GLARGINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
11/15/2019 |
LANTUS SOLOSTAR BLA #021081 |
SUPPL-73 |
INSULIN GLARGINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
11/15/2019 |
LANTUS SOLOSTAR BLA #021081 |
SUPPL-74 |
INSULIN GLARGINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
11/15/2019 |
NOVOLOG MIX 70/30 BLA #021172 |
SUPPL-71 |
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG MIX 70/30 BLA #021172 |
SUPPL-72 |
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG MIX 70/30 FLEXPEN BLA #021172 |
SUPPL-71 |
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG MIX 70/30 FLEXPEN BLA #021172 |
SUPPL-72 |
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG MIX 70/30 PENFILL BLA #021172 |
SUPPL-71 |
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG MIX 70/30 PENFILL BLA #021172 |
SUPPL-72 |
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
LEVEMIR BLA #021536 |
SUPPL-57 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
LEVEMIR BLA #021536 |
SUPPL-58 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
LEVEMIR FLEXPEN BLA #021536 |
SUPPL-57 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
LEVEMIR FLEXPEN BLA #021536 |
SUPPL-58 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
LEVEMIR FLEXTOUCH BLA #021536 |
SUPPL-57 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
LEVEMIR FLEXTOUCH BLA #021536 |
SUPPL-58 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
LEVEMIR INNOLET BLA #021536 |
SUPPL-57 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
LEVEMIR INNOLET BLA #021536 |
SUPPL-58 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
LEVEMIR PENFILL BLA #021536 |
SUPPL-57 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
LEVEMIR PENFILL BLA #021536 |
SUPPL-58 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
APIDRA BLA #021629 |
SUPPL-39 |
INSULIN GLULISINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
11/15/2019 |
APIDRA BLA #021629 |
SUPPL-40 |
INSULIN GLULISINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
11/15/2019 |
APIDRA SOLOSTAR BLA #021629 |
SUPPL-39 |
INSULIN GLULISINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
11/15/2019 |
APIDRA SOLOSTAR BLA #021629 |
SUPPL-40 |
INSULIN GLULISINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
11/15/2019 |
NOVOLOG MIX 50/50 BLA #021810 |
SUPPL-18 |
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
NOVOLOG MIX 50/50 BLA #021810 |
SUPPL-19 |
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
11/15/2019 |
XARELTO NDA #022406 |
SUPPL-27 |
RIVAROXABAN |
JANSSEN PHARMS |
Labeling |
Approval |
11/15/2019 |
NAPROXEN ANDA #074190 |
SUPPL-13 |
NAPROXEN |
HIKMA |
Labeling |
Approval |
11/15/2019 |
NAPROXEN ANDA #074190 |
SUPPL-14 |
NAPROXEN |
HIKMA |
Labeling |
Approval |
11/15/2019 |
NAPROXEN ANDA #074190 |
SUPPL-15 |
NAPROXEN |
HIKMA |
Labeling |
Approval |
11/15/2019 |
ZOLPIDEM TARTRATE ANDA #076410 |
SUPPL-17 |
ZOLPIDEM TARTRATE |
TEVA |
Labeling |
Approval |
11/15/2019 |
ZOLPIDEM TARTRATE ANDA #076410 |
SUPPL-19 |
ZOLPIDEM TARTRATE |
TEVA |
Labeling |
Approval |
11/15/2019 |
ZOLPIDEM TARTRATE ANDA #076410 |
SUPPL-21 |
ZOLPIDEM TARTRATE |
TEVA |
Labeling |
Approval |
11/15/2019 |
ZOLPIDEM TARTRATE ANDA #076410 |
SUPPL-23 |
ZOLPIDEM TARTRATE |
TEVA |
Labeling |
Approval |
11/15/2019 |
ZOLPIDEM TARTRATE ANDA #076410 |
SUPPL-24 |
ZOLPIDEM TARTRATE |
TEVA |
Labeling |
Approval |
11/15/2019 |
MIRTAZAPINE ANDA #077376 |
SUPPL-16 |
MIRTAZAPINE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/15/2019 |
MIRTAZAPINE ANDA #077376 |
SUPPL-17 |
MIRTAZAPINE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/15/2019 |
MIRTAZAPINE ANDA #077376 |
SUPPL-22 |
MIRTAZAPINE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/15/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE ANDA #078894 |
SUPPL-4 |
PRAMIPEXOLE DIHYDROCHLORIDE |
ALEMBIC |
Labeling |
Approval |
11/15/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE ANDA #078894 |
SUPPL-7 |
PRAMIPEXOLE DIHYDROCHLORIDE |
ALEMBIC |
Labeling |
Approval |
11/15/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE ANDA #078920 |
SUPPL-9 |
PRAMIPEXOLE DIHYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
11/15/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE ANDA #078920 |
SUPPL-10 |
PRAMIPEXOLE DIHYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
11/15/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE ANDA #078920 |
SUPPL-12 |
PRAMIPEXOLE DIHYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
11/15/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE ANDA #078920 |
SUPPL-14 |
PRAMIPEXOLE DIHYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
11/15/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE ANDA #078920 |
SUPPL-15 |
PRAMIPEXOLE DIHYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
11/15/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE ANDA #090151 |
SUPPL-5 |
PRAMIPEXOLE DIHYDROCHLORIDE |
ZENNOVA |
Labeling |
Approval |
11/15/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE ANDA #090151 |
SUPPL-6 |
PRAMIPEXOLE DIHYDROCHLORIDE |
ZENNOVA |
Labeling |
Approval |
11/15/2019 |
BLISOVI 24 FE ANDA #091398 |
SUPPL-14 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
11/15/2019 |
ZOLPIDEM TARTRATE ANDA #200266 |
SUPPL-2 |
ZOLPIDEM TARTRATE |
APOTEX |
Labeling |
Approval |
11/15/2019 |
ZOLPIDEM TARTRATE ANDA #200266 |
SUPPL-3 |
ZOLPIDEM TARTRATE |
APOTEX |
Labeling |
Approval |
11/15/2019 |
ZOLPIDEM TARTRATE ANDA #200266 |
SUPPL-4 |
ZOLPIDEM TARTRATE |
APOTEX |
Labeling |
Approval |
11/15/2019 |
ZOLPIDEM TARTRATE ANDA #200266 |
SUPPL-5 |
ZOLPIDEM TARTRATE |
APOTEX |
Labeling |
Approval |
11/15/2019 |
ZOLPIDEM TARTRATE ANDA #200266 |
SUPPL-6 |
ZOLPIDEM TARTRATE |
APOTEX |
Labeling |
Approval |
11/15/2019 |
ZOLPIDEM TARTRATE ANDA #200266 |
SUPPL-7 |
ZOLPIDEM TARTRATE |
APOTEX |
Labeling |
Approval |
11/15/2019 |
ZOLPIDEM TARTRATE ANDA #201509 |
SUPPL-1 |
ZOLPIDEM TARTRATE |
ENDO OPERATIONS |
Labeling |
Approval |
11/15/2019 |
ZOLPIDEM TARTRATE ANDA #201509 |
SUPPL-2 |
ZOLPIDEM TARTRATE |
ENDO OPERATIONS |
Labeling |
Approval |
11/15/2019 |
ENSKYCE ANDA #201887 |
SUPPL-15 |
DESOGESTREL; ETHINYL ESTRADIOL |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
11/15/2019 |
XARELTO NDA #202439 |
SUPPL-34 |
RIVAROXABAN |
JANSSEN PHARMS |
Labeling |
Approval |
11/15/2019 |
RYZODEG 70/30 BLA #203313 |
SUPPL-9 |
INSULIN ASPART; INSULIN DEGLUDEC |
NOVO |
|
Approval |
11/15/2019 |
RYZODEG 70/30 BLA #203313 |
SUPPL-10 |
INSULIN ASPART; INSULIN DEGLUDEC |
NOVO |
|
Approval |
11/15/2019 |
TRESIBA BLA #203314 |
SUPPL-15 |
INSULIN DEGLUDEC |
NOVO |
|
Approval |
11/15/2019 |
TRESIBA BLA #203314 |
SUPPL-16 |
INSULIN DEGLUDEC |
NOVO |
|
Approval |
11/15/2019 |
RABEPRAZOLE SODIUM ANDA #204179 |
SUPPL-2 |
RABEPRAZOLE SODIUM |
AMNEAL PHARMS |
Labeling |
Approval |
11/15/2019 |
RABEPRAZOLE SODIUM ANDA #204179 |
SUPPL-3 |
RABEPRAZOLE SODIUM |
AMNEAL PHARMS |
Labeling |
Approval |
11/15/2019 |
RABEPRAZOLE SODIUM ANDA #204179 |
SUPPL-4 |
RABEPRAZOLE SODIUM |
AMNEAL PHARMS |
Labeling |
Approval |
11/15/2019 |
RABEPRAZOLE SODIUM ANDA #204179 |
SUPPL-5 |
RABEPRAZOLE SODIUM |
AMNEAL PHARMS |
Labeling |
Approval |
11/15/2019 |
BASAGLAR BLA #205692 |
SUPPL-21 |
INSULIN GLARGINE |
ELI LILLY AND CO |
|
Approval |
11/15/2019 |
BASAGLAR BLA #205692 |
SUPPL-24 |
INSULIN GLARGINE |
ELI LILLY AND CO |
|
Approval |
11/15/2019 |
BASAGLAR BLA #205692 |
SUPPL-25 |
INSULIN GLARGINE |
ELI LILLY AND CO |
|
Approval |
11/15/2019 |
HUMALOG KWIKPEN BLA #205747 |
SUPPL-22 |
INSULIN LISPRO RECOMBINANT |
ELI LILLY AND CO |
|
Approval |
11/15/2019 |
HUMALOG KWIKPEN BLA #205747 |
SUPPL-25 |
INSULIN LISPRO RECOMBINANT |
ELI LILLY AND CO |
|
Approval |
11/15/2019 |
HUMALOG KWIKPEN BLA #205747 |
SUPPL-26 |
INSULIN LISPRO RECOMBINANT |
ELI LILLY AND CO |
|
Approval |
11/15/2019 |
HARVONI NDA #205834 |
SUPPL-28 |
LEDIPASVIR; SOFOSBUVIR |
GILEAD SCIENCES INC |
Efficacy |
Approval |
11/15/2019 |
TOUJEO MAX SOLOSTAR BLA #206538 |
SUPPL-13 |
INSULIN GLARGINE RECOMBINANT |
SANOFI US SERVICES |
|
Approval |
11/15/2019 |
TOUJEO MAX SOLOSTAR BLA #206538 |
SUPPL-14 |
INSULIN GLARGINE RECOMBINANT |
SANOFI US SERVICES |
|
Approval |
11/15/2019 |
TOUJEO SOLOSTAR BLA #206538 |
SUPPL-13 |
INSULIN GLARGINE RECOMBINANT |
SANOFI US SERVICES |
|
Approval |
11/15/2019 |
TOUJEO SOLOSTAR BLA #206538 |
SUPPL-14 |
INSULIN GLARGINE RECOMBINANT |
SANOFI US SERVICES |
|
Approval |
11/15/2019 |
DAPTOMYCIN ANDA #207104 |
ORIG-1 |
DAPTOMYCIN |
SAGENT PHARMS INC |
|
Approval |
11/15/2019 |
EPCLUSA NDA #208341 |
SUPPL-12 |
SOFOSBUVIR; VELPATASVIR |
GILEAD SCIENCES INC |
Efficacy |
Approval |
11/15/2019 |
XULTOPHY 100/3.6 BLA #208583 |
SUPPL-14 |
INSULIN DEGLUDEC; LIRAGLUTIDE |
NOVO |
|
Approval |
11/15/2019 |
XULTOPHY 100/3.6 BLA #208583 |
SUPPL-15 |
INSULIN DEGLUDEC; LIRAGLUTIDE |
NOVO |
|
Approval |
11/15/2019 |
SOLIQUA 100/33 BLA #208673 |
SUPPL-8 |
INSULIN GLARGINE; LIXISENATIDE |
SANOFI-AVENTIS US |
|
Approval |
11/15/2019 |
SOLIQUA 100/33 BLA #208673 |
SUPPL-9 |
INSULIN GLARGINE; LIXISENATIDE |
SANOFI-AVENTIS US |
|
Approval |
11/15/2019 |
FIASP BLA #208751 |
SUPPL-12 |
INSULIN ASPART |
NOVO |
|
Approval |
11/15/2019 |
FIASP FLEXTOUCH BLA #208751 |
SUPPL-12 |
INSULIN ASPART |
NOVO |
|
Approval |
11/15/2019 |
FIASP PENFILL BLA #208751 |
SUPPL-12 |
INSULIN ASPART |
NOVO |
|
Approval |
11/15/2019 |
VOSEVI NDA #209195 |
SUPPL-3 |
SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR |
GILEAD SCIENCES INC |
Efficacy |
Approval |
11/15/2019 |
ADMELOG BLA #209196 |
SUPPL-4 |
INSULIN LISPRO |
SANOFI-AVENTIS US |
|
Approval |
11/15/2019 |
ADMELOG BLA #209196 |
SUPPL-5 |
INSULIN LISPRO |
SANOFI-AVENTIS US |
|
Approval |
11/15/2019 |
ADMELOG SOLOSTAR BLA #209196 |
SUPPL-4 |
INSULIN LISPRO |
SANOFI-AVENTIS US |
|
Approval |
11/15/2019 |
ADMELOG SOLOSTAR BLA #209196 |
SUPPL-5 |
INSULIN LISPRO |
SANOFI-AVENTIS US |
|
Approval |
11/15/2019 |
CLOBETASOL PROPIONATE ANDA #211295 |
ORIG-1 |
CLOBETASOL PROPIONATE |
ENCUBE |
|
Approval |
11/15/2019 |
PREDNISONE ANDA #211575 |
ORIG-1 |
PREDNISONE |
NOVITIUM PHARMA |
|
Approval |
11/15/2019 |
HARVONI NDA #212477 |
SUPPL-2 |
LEDIPASVIR; SOFOSBUVIR |
GILEAD SCIENCES INC |
Efficacy |
Approval |
11/15/2019 |
ABRILADA BLA #761118 |
ORIG-1 |
ADALIMUMAB-AFZB |
PFIZER INC |
|
Approval |
11/15/2019 |
ADAKVEO BLA #761128 |
ORIG-1 |
CRIZANLIZUMAB-TMCA |
NOVARTIS PHARMS CORP |
|
Approval |
11/16/2019 |
CEFUROXIME SODIUM ANDA #065046 |
SUPPL-11 |
CEFUROXIME SODIUM |
HIKMA |
Labeling |
Approval |
11/16/2019 |
CEFUROXIME ANDA #065048 |
SUPPL-17 |
CEFUROXIME |
HIKMA |
Labeling |
Approval |
11/16/2019 |
CEFUROXIME SODIUM ANDA #065048 |
SUPPL-17 |
CEFUROXIME SODIUM |
HIKMA |
Labeling |
Approval |
11/16/2019 |
AMPICILLIN AND SULBACTAM ANDA #065176 |
SUPPL-14 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
HQ SPECLT PHARMA |
Labeling |
Approval |
11/16/2019 |
AMPICILLIN AND SULBACTAM ANDA #065188 |
SUPPL-16 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
HQ SPECLT PHARMA |
Labeling |
Approval |
11/18/2019 |
TYLENOL W/ CODEINE NO. 1 ANDA #085055 |
SUPPL-63 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
JANSSEN PHARMS |
Labeling |
Approval |
11/18/2019 |
TYLENOL W/ CODEINE NO. 2 ANDA #085055 |
SUPPL-63 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
JANSSEN PHARMS |
Labeling |
Approval |
11/18/2019 |
TYLENOL W/ CODEINE NO. 3 ANDA #085055 |
SUPPL-63 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
JANSSEN PHARMS |
Labeling |
Approval |
11/18/2019 |
TYLENOL W/ CODEINE NO. 4 ANDA #085055 |
SUPPL-63 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
JANSSEN PHARMS |
Labeling |
Approval |
11/18/2019 |
AMPICILLIN SODIUM ANDA #090581 |
SUPPL-3 |
AMPICILLIN SODIUM |
SAGENT PHARMS INC |
Labeling |
Approval |
11/18/2019 |
TACROLIMUS ANDA #090802 |
SUPPL-7 |
TACROLIMUS |
PANACEA |
Labeling |
Approval |
11/18/2019 |
ECOZA NDA #205175 |
SUPPL-3 |
ECONAZOLE NITRATE |
RESILIA PHARMS |
Labeling |
Approval |
11/18/2019 |
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM ANDA #205199 |
ORIG-1 |
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM |
APOTEX |
|
Approval |
11/18/2019 |
NYSTATIN AND TRIAMCINOLONE ACETONIDE ANDA #207316 |
ORIG-1 |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
CHARTWELL RX |
|
Approval |
11/18/2019 |
DILTIAZEM HYDROCHLORIDE ANDA #211596 |
ORIG-1 |
DILTIAZEM HYDROCHLORIDE |
EDENBRIDGE PHARMS |
|
Approval |
11/18/2019 |
IRINOTECAN HYDROCHLORIDE ANDA #212993 |
ORIG-1 |
IRINOTECAN HYDROCHLORIDE |
GLAND PHARMA LTD |
|
Approval |
11/19/2019 |
RITALIN NDA #010187 |
SUPPL-91 |
METHYLPHENIDATE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
11/19/2019 |
RITALIN-SR NDA #018029 |
SUPPL-59 |
METHYLPHENIDATE HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
11/19/2019 |
FOCALIN NDA #021278 |
SUPPL-26 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
11/19/2019 |
RITALIN LA NDA #021284 |
SUPPL-41 |
METHYLPHENIDATE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
11/19/2019 |
FOCALIN XR NDA #021802 |
SUPPL-36 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #077322 |
SUPPL-15 |
ZOLPIDEM TARTRATE |
SANDOZ |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #077322 |
SUPPL-16 |
ZOLPIDEM TARTRATE |
SANDOZ |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #077322 |
SUPPL-17 |
ZOLPIDEM TARTRATE |
SANDOZ |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #077322 |
SUPPL-18 |
ZOLPIDEM TARTRATE |
SANDOZ |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #078148 |
SUPPL-11 |
ZOLPIDEM TARTRATE |
ENDO OPERATIONS |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #078148 |
SUPPL-12 |
ZOLPIDEM TARTRATE |
ENDO OPERATIONS |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #078148 |
SUPPL-13 |
ZOLPIDEM TARTRATE |
ENDO OPERATIONS |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #078148 |
SUPPL-15 |
ZOLPIDEM TARTRATE |
ENDO OPERATIONS |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #078179 |
SUPPL-14 |
ZOLPIDEM TARTRATE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #078179 |
SUPPL-15 |
ZOLPIDEM TARTRATE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #078179 |
SUPPL-16 |
ZOLPIDEM TARTRATE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
11/19/2019 |
TENOFOVIR DISOPROXIL FUMARATE ANDA #078800 |
SUPPL-17 |
TENOFOVIR DISOPROXIL FUMARATE |
CIPLA |
Labeling |
Approval |
11/19/2019 |
TENOFOVIR DISOPROXIL FUMARATE ANDA #078800 |
SUPPL-18 |
TENOFOVIR DISOPROXIL FUMARATE |
CIPLA |
Labeling |
Approval |
11/19/2019 |
TENOFOVIR DISOPROXIL FUMARATE ANDA #078800 |
SUPPL-19 |
TENOFOVIR DISOPROXIL FUMARATE |
CIPLA |
Labeling |
Approval |
11/19/2019 |
TENOFOVIR DISOPROXIL FUMARATE ANDA #078800 |
SUPPL-20 |
TENOFOVIR DISOPROXIL FUMARATE |
CIPLA |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #090107 |
SUPPL-6 |
ZOLPIDEM TARTRATE |
SANDOZ |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #090107 |
SUPPL-7 |
ZOLPIDEM TARTRATE |
SANDOZ |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #090107 |
SUPPL-8 |
ZOLPIDEM TARTRATE |
SANDOZ |
Labeling |
Approval |
11/19/2019 |
ZOLPIDEM TARTRATE ANDA #090107 |
SUPPL-9 |
ZOLPIDEM TARTRATE |
SANDOZ |
Labeling |
Approval |
11/19/2019 |
TENOFOVIR DISOPROXIL FUMARATE ANDA #090742 |
SUPPL-12 |
TENOFOVIR DISOPROXIL FUMARATE |
STRIDES PHARMA |
Labeling |
Approval |
11/19/2019 |
XYOSTED (AUTOINJECTOR) NDA #209863 |
SUPPL-2 |
TESTOSTERONE ENANTHATE |
ANTARES PHARMA INC |
Labeling |
Approval |
11/19/2019 |
TURALIO NDA #211810 |
SUPPL-1 |
PEXIDARTINIB HYDROCHLORIDE |
DAIICHI SANKYO INC |
REMS |
Approval |
11/19/2019 |
TURALIO NDA #211810 |
SUPPL-2 |
PEXIDARTINIB HYDROCHLORIDE |
DAIICHI SANKYO INC |
REMS |
Approval |
11/20/2019 |
CAYSTON NDA #050814 |
SUPPL-23 |
AZTREONAM |
GILEAD |
Labeling |
Approval |
11/20/2019 |
MIRTAZAPINE ANDA #076541 |
SUPPL-24 |
MIRTAZAPINE |
SUN PHARM INDS INC |
Labeling |
Approval |
11/20/2019 |
LAMOTRIGINE ANDA #077420 |
SUPPL-17 |
LAMOTRIGINE |
RISING |
Labeling |
Approval |
11/20/2019 |
LAMOTRIGINE ANDA #077420 |
SUPPL-18 |
LAMOTRIGINE |
RISING |
Labeling |
Approval |
11/20/2019 |
FOSAMPRENAVIR CALCIUM ANDA #204024 |
ORIG-1 |
FOSAMPRENAVIR CALCIUM |
SUN PHARM |
|
Approval |
11/20/2019 |
HEPARIN SODIUM ANDA #205323 |
SUPPL-1 |
HEPARIN SODIUM |
GLAND |
Labeling |
Approval |
11/20/2019 |
TENOFOVIR DISOPROXIL FUMARATE ANDA #206481 |
SUPPL-1 |
TENOFOVIR DISOPROXIL FUMARATE |
CHARTWELL |
Labeling |
Approval |
11/20/2019 |
TENOFOVIR DISOPROXIL FUMARATE ANDA #206481 |
SUPPL-2 |
TENOFOVIR DISOPROXIL FUMARATE |
CHARTWELL |
Labeling |
Approval |
11/20/2019 |
TENOFOVIR DISOPROXIL FUMARATE ANDA #206481 |
SUPPL-3 |
TENOFOVIR DISOPROXIL FUMARATE |
CHARTWELL |
Labeling |
Approval |
11/20/2019 |
TENOFOVIR DISOPROXIL FUMARATE ANDA #206481 |
SUPPL-4 |
TENOFOVIR DISOPROXIL FUMARATE |
CHARTWELL |
Labeling |
Approval |
11/20/2019 |
MESALAMINE ANDA #207271 |
ORIG-1 |
MESALAMINE |
MYLAN |
|
Approval |
11/20/2019 |
DEFERASIROX ANDA #209782 |
ORIG-1 |
DEFERASIROX |
SUN PHARM |
|
Approval |
11/20/2019 |
DEFERASIROX ANDA #209878 |
ORIG-1 |
DEFERASIROX |
MSN |
|
Approval |
11/20/2019 |
DEFERASIROX ANDA #210060 |
ORIG-1 |
DEFERASIROX |
ALEMBIC |
|
Approval |
11/20/2019 |
DESONIDE ANDA #210198 |
ORIG-1 |
DESONIDE |
CADILA |
|
Approval |
11/20/2019 |
DEFERASIROX ANDA #210519 |
ORIG-1 |
DEFERASIROX |
ALKEM LABS LTD |
|
Approval |
11/20/2019 |
DEFERASIROX ANDA #210920 |
ORIG-1 |
DEFERASIROX |
BIONPHARMA |
|
Approval |
11/20/2019 |
DEFERASIROX ANDA #210945 |
ORIG-1 |
DEFERASIROX |
MSN |
|
Approval |
11/20/2019 |
DEFERASIROX ANDA #211383 |
ORIG-1 |
DEFERASIROX |
ZYDUS PHARMS |
|
Approval |
11/20/2019 |
DEFERASIROX ANDA #211824 |
ORIG-1 |
DEFERASIROX |
ALEMBIC |
|
Approval |
11/20/2019 |
GIVLAARI NDA #212194 |
ORIG-1 |
GIVOSIRAN SODIUM |
ALNYLAM PHARMS INC |
Type 1 - New Molecular Entity |
Approval |
11/20/2019 |
MIDODRINE HYDROCHLORIDE ANDA #212543 |
SUPPL-1 |
MIDODRINE HYDROCHLORIDE |
RUBICON |
Labeling |
Approval |
11/20/2019 |
ISOSORBIDE DINITRATE ANDA #213057 |
ORIG-1 |
ISOSORBIDE DINITRATE |
ZYDUS LIFESCIENCES |
|
Approval |
11/21/2019 |
CORTEF NDA #008697 |
SUPPL-36 |
HYDROCORTISONE |
PHARMACIA AND UPJOHN |
Labeling |
Approval |
11/21/2019 |
SOLU-CORTEF NDA #009866 |
SUPPL-113 |
HYDROCORTISONE SODIUM SUCCINATE |
PHARMACIA AND UPJOHN |
Labeling |
Approval |
11/21/2019 |
FASLODEX NDA #021344 |
SUPPL-38 |
FULVESTRANT |
ASTRAZENECA |
Efficacy |
Approval |
11/21/2019 |
TREANDA NDA #022249 |
SUPPL-24 |
BENDAMUSTINE HYDROCHLORIDE |
CEPHALON |
Labeling |
Approval |
11/21/2019 |
AMIODARONE HYDROCHLORIDE ANDA #075315 |
SUPPL-45 |
AMIODARONE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
11/21/2019 |
AMIODARONE HYDROCHLORIDE ANDA #075315 |
SUPPL-46 |
AMIODARONE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
11/21/2019 |
AMIODARONE HYDROCHLORIDE ANDA #075315 |
SUPPL-47 |
AMIODARONE HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
11/21/2019 |
AMIODARONE HYDROCHLORIDE ANDA #075389 |
SUPPL-12 |
AMIODARONE HYDROCHLORIDE |
DR REDDYS LABS SA |
Labeling |
Approval |
11/21/2019 |
LAMOTRIGINE ANDA #078134 |
SUPPL-8 |
LAMOTRIGINE |
HIKMA PHARMS |
Labeling |
Approval |
11/21/2019 |
LAMOTRIGINE ANDA #078134 |
SUPPL-9 |
LAMOTRIGINE |
HIKMA PHARMS |
Labeling |
Approval |
11/21/2019 |
AMIODARONE HYDROCHLORIDE ANDA #078578 |
SUPPL-7 |
AMIODARONE HYDROCHLORIDE |
RUBICON |
Labeling |
Approval |
11/21/2019 |
AMIODARONE HYDROCHLORIDE ANDA #078578 |
SUPPL-8 |
AMIODARONE HYDROCHLORIDE |
RUBICON |
Labeling |
Approval |
11/21/2019 |
AMIODARONE HYDROCHLORIDE ANDA #078578 |
SUPPL-9 |
AMIODARONE HYDROCHLORIDE |
RUBICON |
Labeling |
Approval |
11/21/2019 |
AMIODARONE HYDROCHLORIDE ANDA #078578 |
SUPPL-10 |
AMIODARONE HYDROCHLORIDE |
RUBICON |
Labeling |
Approval |
11/21/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE ANDA #090781 |
SUPPL-7 |
PRAMIPEXOLE DIHYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
11/21/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE ANDA #090781 |
SUPPL-8 |
PRAMIPEXOLE DIHYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
11/21/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE ANDA #090865 |
SUPPL-18 |
PRAMIPEXOLE DIHYDROCHLORIDE |
TORRENT PHARMS |
Labeling |
Approval |
11/21/2019 |
LAMOTRIGINE ANDA #200672 |
SUPPL-3 |
LAMOTRIGINE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
11/21/2019 |
LAMOTRIGINE ANDA #200672 |
SUPPL-6 |
LAMOTRIGINE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
11/21/2019 |
LAMOTRIGINE ANDA #200672 |
SUPPL-8 |
LAMOTRIGINE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
11/21/2019 |
LAMOTRIGINE ANDA #200672 |
SUPPL-9 |
LAMOTRIGINE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
11/21/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE ANDA #202164 |
SUPPL-10 |
PRAMIPEXOLE DIHYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/21/2019 |
PRAMIPEXOLE DIHYDROCHLORIDE ANDA #202164 |
SUPPL-15 |
PRAMIPEXOLE DIHYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/21/2019 |
AMPICILLIN AND SULBACTAM ANDA #202197 |
SUPPL-4 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
STERISCIENCE SPECLTS |
Labeling |
Approval |
11/21/2019 |
LEVETIRACETAM IN SODIUM CHLORIDE NDA #202543 |
SUPPL-15 |
LEVETIRACETAM |
HQ SPCLT PHARMA |
Labeling |
Approval |
11/21/2019 |
MYCOPHENOLIC SODIUM ANDA #202720 |
SUPPL-2 |
MYCOPHENOLIC SODIUM |
TEVA PHARMS USA |
Labeling |
Approval |
11/21/2019 |
LAMOTRIGINE ANDA #203370 |
SUPPL-7 |
LAMOTRIGINE |
TORRENT |
Labeling |
Approval |
11/21/2019 |
LAMOTRIGINE ANDA #203370 |
SUPPL-9 |
LAMOTRIGINE |
TORRENT |
Labeling |
Approval |
11/21/2019 |
AMIODARONE HYDROCHLORIDE ANDA #204742 |
SUPPL-2 |
AMIODARONE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/21/2019 |
AMIODARONE HYDROCHLORIDE ANDA #204742 |
SUPPL-4 |
AMIODARONE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/21/2019 |
AMIODARONE HYDROCHLORIDE ANDA #204742 |
SUPPL-6 |
AMIODARONE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/21/2019 |
IMBRUVICA NDA #205552 |
SUPPL-29 |
IBRUTINIB |
PHARMACYCLICS LLC |
Labeling |
Approval |
11/21/2019 |
OSELTAMIVIR PHOSPHATE ANDA #208348 |
SUPPL-4 |
OSELTAMIVIR PHOSPHATE |
LUPIN |
Labeling |
Approval |
11/21/2019 |
OSELTAMIVIR PHOSPHATE ANDA #208348 |
SUPPL-5 |
OSELTAMIVIR PHOSPHATE |
LUPIN |
Labeling |
Approval |
11/21/2019 |
IMVEXXY NDA #208564 |
SUPPL-3 |
ESTRADIOL |
MAYNE PHARMA |
Labeling |
Approval |
11/21/2019 |
FULVESTRANT ANDA #209714 |
ORIG-1 |
FULVESTRANT |
HBT LABS INC |
|
Approval |
11/21/2019 |
CALQUENCE NDA #210259 |
SUPPL-6 |
ACALABRUTINIB |
ASTRAZENECA |
Efficacy |
Approval |
11/21/2019 |
CALQUENCE NDA #210259 |
SUPPL-7 |
ACALABRUTINIB |
ASTRAZENECA |
Efficacy |
Approval |
11/21/2019 |
IMBRUVICA NDA #210563 |
SUPPL-4 |
IBRUTINIB |
PHARMACYCLICS LLC |
Labeling |
Approval |
11/21/2019 |
XCOPRI NDA #212839 |
ORIG-1 |
CENOBAMATE |
SK LIFE |
Type 1 - New Molecular Entity |
Approval |
11/21/2019 |
ATENOLOL ANDA #213136 |
ORIG-1 |
ATENOLOL |
UNICHEM |
|
Approval |
11/22/2019 |
DARANIDE NDA #011366 |
SUPPL-33 |
DICHLORPHENAMIDE |
XERIS |
Efficacy |
Approval |
11/22/2019 |
KEVEYIS NDA #011366 |
SUPPL-33 |
DICHLORPHENAMIDE |
XERIS |
Efficacy |
Approval |
11/22/2019 |
DEPAKENE NDA #018081 |
SUPPL-70 |
VALPROIC ACID |
ABBVIE |
Labeling |
Approval |
11/22/2019 |
DEPAKENE NDA #018082 |
SUPPL-53 |
VALPROIC ACID |
ABBVIE |
Labeling |
Approval |
11/22/2019 |
DEPAKOTE NDA #018723 |
SUPPL-62 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
11/22/2019 |
DEPAKOTE NDA #019680 |
SUPPL-49 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
11/22/2019 |
DEPACON NDA #020593 |
SUPPL-40 |
VALPROATE SODIUM |
ABBVIE |
Labeling |
Approval |
11/22/2019 |
TEMODAR NDA #021029 |
SUPPL-33 |
TEMOZOLOMIDE |
MERCK SHARP DOHME |
Labeling |
Approval |
11/22/2019 |
DEPAKOTE ER NDA #021168 |
SUPPL-40 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
11/22/2019 |
RISPERDAL CONSTA NDA #021346 |
SUPPL-62 |
RISPERIDONE |
JANSSEN PHARMS |
Labeling |
Approval |
11/22/2019 |
TEMODAR NDA #022277 |
SUPPL-13 |
TEMOZOLOMIDE |
MERCK SHARP DOHME |
Labeling |
Approval |
11/22/2019 |
PRADAXA NDA #022512 |
SUPPL-38 |
DABIGATRAN ETEXILATE MESYLATE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
11/22/2019 |
NAMENDA XR NDA #022525 |
SUPPL-15 |
MEMANTINE HYDROCHLORIDE |
ABBVIE |
Labeling |
Approval |
11/22/2019 |
AMPICILLIN TRIHYDRATE ANDA #062883 |
SUPPL-14 |
AMPICILLIN/AMPICILLIN TRIHYDRATE |
STRIDES PHARMA |
Labeling |
Approval |
11/22/2019 |
NAPROXEN ANDA #075927 |
SUPPL-25 |
NAPROXEN |
AMNEAL PHARMS NY |
Labeling |
Approval |
11/22/2019 |
NAPROXEN ANDA #075927 |
SUPPL-27 |
NAPROXEN |
AMNEAL PHARMS NY |
Labeling |
Approval |
11/22/2019 |
NAPROXEN ANDA #075927 |
SUPPL-31 |
NAPROXEN |
AMNEAL PHARMS NY |
Labeling |
Approval |
11/22/2019 |
MIRTAZAPINE ANDA #076122 |
SUPPL-22 |
MIRTAZAPINE |
MYLAN |
Labeling |
Approval |
11/22/2019 |
MIRTAZAPINE ANDA #076122 |
SUPPL-24 |
MIRTAZAPINE |
MYLAN |
Labeling |
Approval |
11/22/2019 |
MIRTAZAPINE ANDA #076122 |
SUPPL-25 |
MIRTAZAPINE |
MYLAN |
Labeling |
Approval |
11/22/2019 |
CLOPIDOGREL BISULFATE ANDA #076274 |
SUPPL-10 |
CLOPIDOGREL BISULFATE |
APOTEX INC |
Labeling |
Approval |
11/22/2019 |
CLOPIDOGREL BISULFATE ANDA #076274 |
SUPPL-11 |
CLOPIDOGREL BISULFATE |
APOTEX INC |
Labeling |
Approval |
11/22/2019 |
CLOPIDOGREL BISULFATE ANDA #076274 |
SUPPL-14 |
CLOPIDOGREL BISULFATE |
APOTEX INC |
Labeling |
Approval |
11/22/2019 |
CLOPIDOGREL BISULFATE ANDA #076274 |
SUPPL-16 |
CLOPIDOGREL BISULFATE |
APOTEX INC |
Labeling |
Approval |
11/22/2019 |
CLOPIDOGREL BISULFATE ANDA #076274 |
SUPPL-17 |
CLOPIDOGREL BISULFATE |
APOTEX INC |
Labeling |
Approval |
11/22/2019 |
CLOPIDOGREL BISULFATE ANDA #076274 |
SUPPL-18 |
CLOPIDOGREL BISULFATE |
APOTEX INC |
Labeling |
Approval |
11/22/2019 |
CLOPIDOGREL BISULFATE ANDA #076274 |
SUPPL-20 |
CLOPIDOGREL BISULFATE |
APOTEX INC |
Labeling |
Approval |
11/22/2019 |
CLOPIDOGREL BISULFATE ANDA #076274 |
SUPPL-23 |
CLOPIDOGREL BISULFATE |
APOTEX INC |
Labeling |
Approval |
11/22/2019 |
MIRTAZAPINE ANDA #076921 |
SUPPL-29 |
MIRTAZAPINE |
AUROBINDO |
Labeling |
Approval |
11/22/2019 |
MIRTAZAPINE ANDA #076921 |
SUPPL-30 |
MIRTAZAPINE |
AUROBINDO |
Labeling |
Approval |
11/22/2019 |
MIRTAZAPINE ANDA #076921 |
SUPPL-35 |
MIRTAZAPINE |
AUROBINDO |
Labeling |
Approval |
11/22/2019 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE ANDA #077183 |
SUPPL-13 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
DR REDDYS LABS INC |
Labeling |
Approval |
11/22/2019 |
MIRTAZAPINE ANDA #077666 |
SUPPL-10 |
MIRTAZAPINE |
APOTEX INC |
Labeling |
Approval |
11/22/2019 |
MIRTAZAPINE ANDA #077666 |
SUPPL-11 |
MIRTAZAPINE |
APOTEX INC |
Labeling |
Approval |
11/22/2019 |
MIRTAZAPINE ANDA #077666 |
SUPPL-13 |
MIRTAZAPINE |
APOTEX INC |
Labeling |
Approval |
11/22/2019 |
QUETIAPINE FUMARATE ANDA #077745 |
SUPPL-11 |
QUETIAPINE FUMARATE |
TEVA PHARMS |
Labeling |
Approval |
11/22/2019 |
QUETIAPINE FUMARATE ANDA #077745 |
SUPPL-12 |
QUETIAPINE FUMARATE |
TEVA PHARMS |
Labeling |
Approval |
11/22/2019 |
PAMIDRONATE DISODIUM ANDA #078373 |
SUPPL-5 |
PAMIDRONATE DISODIUM |
SAGENT PHARMS INC |
Labeling |
Approval |
11/22/2019 |
MYCOPHENOLATE MOFETIL ANDA #090055 |
SUPPL-14 |
MYCOPHENOLATE MOFETIL |
STRIDES PHARMA |
Labeling |
Approval |
11/22/2019 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE ANDA #090149 |
SUPPL-8 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
DR REDDYS LABS INC |
Labeling |
Approval |
11/22/2019 |
MYCOPHENOLATE MOFETIL ANDA #090456 |
SUPPL-16 |
MYCOPHENOLATE MOFETIL |
STRIDES PHARMA |
Labeling |
Approval |
11/22/2019 |
BIVALIRUDIN ANDA #090811 |
SUPPL-3 |
BIVALIRUDIN |
HOSPIRA |
Labeling |
Approval |
11/22/2019 |
BIVALIRUDIN ANDA #090811 |
SUPPL-5 |
BIVALIRUDIN |
HOSPIRA |
Labeling |
Approval |
11/22/2019 |
BIVALIRUDIN ANDA #090811 |
SUPPL-8 |
BIVALIRUDIN |
HOSPIRA |
Labeling |
Approval |
11/22/2019 |
BIVALIRUDIN ANDA #090811 |
SUPPL-10 |
BIVALIRUDIN |
HOSPIRA |
Labeling |
Approval |
11/22/2019 |
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE ANDA #091211 |
SUPPL-9 |
ATOVAQUONE; PROGUANIL HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
11/22/2019 |
NAPROXEN SODIUM ANDA #091353 |
SUPPL-8 |
NAPROXEN SODIUM |
GRANULES INDIA |
Labeling |
Approval |
11/22/2019 |
NAPROXEN SODIUM ANDA #091353 |
SUPPL-10 |
NAPROXEN SODIUM |
GRANULES INDIA |
Labeling |
Approval |
11/22/2019 |
NAPROXEN SODIUM ANDA #091353 |
SUPPL-13 |
NAPROXEN SODIUM |
GRANULES INDIA |
Labeling |
Approval |
11/22/2019 |
QUETIAPINE FUMARATE ANDA #202152 |
SUPPL-15 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
11/22/2019 |
QUETIAPINE FUMARATE ANDA #202152 |
SUPPL-16 |
QUETIAPINE FUMARATE |
ACCORD HLTHCARE |
Labeling |
Approval |
11/22/2019 |
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE ANDA #202362 |
SUPPL-3 |
ATOVAQUONE; PROGUANIL HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
11/22/2019 |
LAMOTRIGINE ANDA #202887 |
SUPPL-8 |
LAMOTRIGINE |
RUBICON |
Labeling |
Approval |
11/22/2019 |
LAMOTRIGINE ANDA #202887 |
SUPPL-11 |
LAMOTRIGINE |
RUBICON |
Labeling |
Approval |
11/22/2019 |
CABAZITAXEL NDA #207937 |
ORIG-1 |
CABAZITAXEL |
FRESENIUS KABI USA |
Type 5 - New Formulation or New Manufacturer |
Tentative Approval |
11/22/2019 |
CABAZITAXEL NDA #207937 |
SUPPL-1 |
CABAZITAXEL |
FRESENIUS KABI USA |
Type 5 - New Formulation or New Manufacturer |
Tentative Approval |
11/22/2019 |
SILODOSIN ANDA #211731 |
ORIG-1 |
SILODOSIN |
ALEMBIC |
|
Approval |
11/22/2019 |
EXSERVAN NDA #212640 |
ORIG-1 |
RILUZOLE |
AQUESTIVE |
Type 3 - New Dosage Form |
Approval |
11/22/2019 |
AMPHETAMINE SULFATE ANDA #212919 |
ORIG-1 |
AMPHETAMINE SULFATE |
BIONPHARMA |
|
Approval |
11/22/2019 |
BUTALBITAL AND ACETAMINOPHEN ANDA #213115 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL |
GRANULES |
|
Approval |
11/22/2019 |
TREMFYA BLA #761061 |
SUPPL-4 |
GUSELKUMAB |
JANSSEN BIOTECH |
|
Approval |
11/25/2019 |
NIZORAL ANTI-DANDRUFF NDA #020310 |
SUPPL-23 |
KETOCONAZOLE |
KRAMER |
Labeling |
Approval |
11/25/2019 |
NAPROXEN SODIUM ANDA #075416 |
SUPPL-19 |
NAPROXEN SODIUM |
ACTAVIS LABS FL INC |
Labeling |
Approval |
11/25/2019 |
FLUTICASONE PROPIONATE ANDA #076300 |
SUPPL-5 |
FLUTICASONE PROPIONATE |
FOUGERA PHARMS |
Labeling |
Approval |
11/25/2019 |
FLUTICASONE PROPIONATE ANDA #076504 |
SUPPL-11 |
FLUTICASONE PROPIONATE |
HIKMA |
Labeling |
Approval |
11/25/2019 |
FLUTICASONE PROPIONATE ANDA #077145 |
SUPPL-1 |
FLUTICASONE PROPIONATE |
TARO PHARM INDS |
Labeling |
Approval |
11/25/2019 |
FLUTICASONE PROPIONATE ANDA #077168 |
SUPPL-7 |
FLUTICASONE PROPIONATE |
COSETTE |
Labeling |
Approval |
11/25/2019 |
LEVETIRACETAM ANDA #091399 |
SUPPL-14 |
LEVETIRACETAM |
LUPIN LTD |
Labeling |
Approval |
11/25/2019 |
LEVETIRACETAM ANDA #091399 |
SUPPL-16 |
LEVETIRACETAM |
LUPIN LTD |
Labeling |
Approval |
11/25/2019 |
LEVETIRACETAM ANDA #091399 |
SUPPL-17 |
LEVETIRACETAM |
LUPIN LTD |
Labeling |
Approval |
11/25/2019 |
LEVETIRACETAM ANDA #091399 |
SUPPL-18 |
LEVETIRACETAM |
LUPIN LTD |
Labeling |
Approval |
11/25/2019 |
LEVETIRACETAM ANDA #091399 |
SUPPL-21 |
LEVETIRACETAM |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
11/25/2019 |
NAPROXEN ANDA #091432 |
SUPPL-3 |
NAPROXEN |
NUVO PHARMS INC |
Labeling |
Approval |
11/25/2019 |
NAPROXEN ANDA #091432 |
SUPPL-6 |
NAPROXEN |
NUVO PHARMS INC |
Labeling |
Approval |
11/25/2019 |
NAPROXEN ANDA #091432 |
SUPPL-9 |
NAPROXEN |
NUVO PHARMS INC |
Labeling |
Approval |
11/25/2019 |
RITUXAN BLA #103705 |
SUPPL-5459 |
RITUXIMAB |
GENENTECH |
|
Approval |
11/25/2019 |
ZALTRAP BLA #125418 |
SUPPL-45 |
ZIV-AFLIBERCEPT |
SANOFI AVENTIS US |
|
Approval |
11/25/2019 |
MYCOPHENOLATE MOFETIL ANDA #203005 |
SUPPL-8 |
MYCOPHENOLATE MOFETIL |
ALKEM LABS LTD |
Labeling |
Approval |
11/25/2019 |
XADAGO NDA #207145 |
SUPPL-5 |
SAFINAMIDE MESYLATE |
MDD US |
Labeling |
Approval |
11/25/2019 |
DEFERASIROX ANDA #209223 |
ORIG-1 |
DEFERASIROX |
TEVA PHARMS USA |
|
Approval |
11/25/2019 |
MYCOPHENOLATE MOFETIL ANDA #210181 |
SUPPL-1 |
MYCOPHENOLATE MOFETIL |
CONCORD BIOTECH LTD |
Labeling |
Approval |
11/25/2019 |
MYCOPHENOLATE MOFETIL ANDA #210370 |
SUPPL-2 |
MYCOPHENOLATE MOFETIL |
VISTAPHARM |
Labeling |
Approval |
11/25/2019 |
PILOCARPINE HYDROCHLORIDE ANDA #210384 |
ORIG-1 |
PILOCARPINE HYDROCHLORIDE |
SOMERSET THERAPS LLC |
|
Approval |
11/25/2019 |
CLADRIBINE ANDA #210856 |
ORIG-1 |
CLADRIBINE |
HISUN PHARM HANGZHOU |
|
Approval |
11/25/2019 |
METFORMIN HYDROCHLORIDE ANDA #212969 |
ORIG-1 |
METFORMIN HYDROCHLORIDE |
GLENMARK PHARMS LTD |
|
Approval |
11/25/2019 |
OXBRYTA NDA #213137 |
ORIG-1 |
VOXELOTOR |
GLOBAL BLOOD THERAPS |
Type 1 - New Molecular Entity |
Approval |
11/26/2019 |
MAGNESIUM SULFATE ANDA #075151 |
SUPPL-15 |
MAGNESIUM SULFATE |
HOSPIRA |
Labeling |
Approval |
11/26/2019 |
NAPROXEN ANDA #076494 |
SUPPL-15 |
NAPROXEN |
HIKMA INTL PHARMS |
Labeling |
Approval |
11/26/2019 |
NAPROXEN ANDA #076494 |
SUPPL-16 |
NAPROXEN |
HIKMA INTL PHARMS |
Labeling |
Approval |
11/26/2019 |
NAPROXEN ANDA #076494 |
SUPPL-17 |
NAPROXEN |
HIKMA INTL PHARMS |
Labeling |
Approval |
11/26/2019 |
GEMFIBROZIL ANDA #077836 |
SUPPL-14 |
GEMFIBROZIL |
INVAGEN PHARMS |
Labeling |
Approval |
11/26/2019 |
RISPERIDONE ANDA #078516 |
SUPPL-13 |
RISPERIDONE |
ZYDUS PHARMS USA |
Labeling |
Approval |
11/26/2019 |
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE ANDA #078959 |
SUPPL-6 |
EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE |
SEPTODONT INC |
Labeling |
Approval |
11/26/2019 |
CAMPATH BLA #103948 |
SUPPL-5171 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
11/26/2019 |
LEMTRADA BLA #103948 |
SUPPL-5171 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
11/26/2019 |
ELIQUIS NDA #202155 |
SUPPL-24 |
APIXABAN |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
11/26/2019 |
SYNRIBO NDA #203585 |
SUPPL-7 |
OMACETAXINE MEPESUCCINATE |
TEVA PHARMS INTL |
Labeling |
Approval |
11/26/2019 |
TOUJEO MAX SOLOSTAR BLA #206538 |
SUPPL-12 |
INSULIN GLARGINE RECOMBINANT |
SANOFI US SERVICES |
|
Approval |
11/26/2019 |
TOUJEO SOLOSTAR BLA #206538 |
SUPPL-12 |
INSULIN GLARGINE RECOMBINANT |
SANOFI US SERVICES |
|
Approval |
11/26/2019 |
RIVASTIGMINE ANDA #209063 |
ORIG-1 |
RIVASTIGMINE |
BRECKENRIDGE |
|
Approval |
11/26/2019 |
AMINOCAPROIC ACID ANDA #212492 |
ORIG-1 |
AMINOCAPROIC ACID |
AMNEAL |
|
Approval |
11/26/2019 |
POTASSIUM PHOSPHATES NDA #212832 |
ORIG-1 |
POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC |
FRESENIUS KABI USA |
Type 5 - New Formulation or New Manufacturer |
Approval |
11/26/2019 |
FLUOCINONIDE ANDA #212976 |
ORIG-1 |
FLUOCINONIDE |
XIROMED |
|
Approval |
11/27/2019 |
LIPITOR NDA #020702 |
SUPPL-74 |
ATORVASTATIN CALCIUM |
UPJOHN |
Labeling |
Approval |
11/27/2019 |
TRIAMCINOLONE ACETONIDE ANDA #040039 |
SUPPL-17 |
TRIAMCINOLONE ACETONIDE |
TARO |
Labeling |
Approval |
11/27/2019 |
MYCOPHENOLATE MOFETIL ANDA #065410 |
SUPPL-12 |
MYCOPHENOLATE MOFETIL |
HIKMA |
Labeling |
Approval |
11/27/2019 |
MYCOPHENOLATE MOFETIL ANDA #065413 |
SUPPL-13 |
MYCOPHENOLATE MOFETIL |
HIKMA |
Labeling |
Approval |
11/27/2019 |
DIVALPROEX SODIUM ANDA #077615 |
SUPPL-11 |
DIVALPROEX SODIUM |
APOTEX |
Labeling |
Approval |
11/27/2019 |
DIVALPROEX SODIUM ANDA #077615 |
SUPPL-12 |
DIVALPROEX SODIUM |
APOTEX |
Labeling |
Approval |
11/27/2019 |
DIVALPROEX SODIUM ANDA #077615 |
SUPPL-13 |
DIVALPROEX SODIUM |
APOTEX |
Labeling |
Approval |
11/27/2019 |
DIVALPROEX SODIUM ANDA #077615 |
SUPPL-14 |
DIVALPROEX SODIUM |
APOTEX |
Labeling |
Approval |
11/27/2019 |
DIVALPROEX SODIUM ANDA #077615 |
SUPPL-15 |
DIVALPROEX SODIUM |
APOTEX |
Labeling |
Approval |
11/27/2019 |
DIVALPROEX SODIUM ANDA #077615 |
SUPPL-16 |
DIVALPROEX SODIUM |
APOTEX |
Labeling |
Approval |
11/27/2019 |
DIVALPROEX SODIUM ANDA #077615 |
SUPPL-17 |
DIVALPROEX SODIUM |
APOTEX |
Labeling |
Approval |
11/27/2019 |
FLUTICASONE PROPIONATE ANDA #091553 |
SUPPL-4 |
FLUTICASONE PROPIONATE |
PADAGIS ISRAEL |
Labeling |
Approval |
11/27/2019 |
FLUTICASONE PROPIONATE ANDA #091553 |
SUPPL-9 |
FLUTICASONE PROPIONATE |
PADAGIS ISRAEL |
Labeling |
Approval |
11/27/2019 |
COMPLERA NDA #202123 |
SUPPL-31 |
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
11/27/2019 |
MOXIFLOXACIN HYDROCHLORIDE ANDA #202525 |
SUPPL-1 |
MOXIFLOXACIN HYDROCHLORIDE |
ADAPTIS |
Labeling |
Approval |
11/27/2019 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE ANDA #204043 |
SUPPL-1 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
RISING |
Labeling |
Approval |
11/27/2019 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE ANDA #204043 |
SUPPL-3 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
RISING |
Labeling |
Approval |
11/27/2019 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE ANDA #204043 |
SUPPL-4 |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
RISING |
Labeling |
Approval |
11/27/2019 |
MACRILEN NDA #205598 |
SUPPL-3 |
MACIMORELIN ACETATE |
NOVO |
Labeling |
Approval |
11/27/2019 |
MAGNESIUM SULFATE ANDA #206039 |
SUPPL-3 |
MAGNESIUM SULFATE |
EXELA PHARMA |
Labeling |
Approval |
11/27/2019 |
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #207349 |
SUPPL-5 |
MAGNESIUM SULFATE |
HQ SPCLT PHARMA |
Labeling |
Approval |
11/27/2019 |
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #207349 |
SUPPL-7 |
MAGNESIUM SULFATE |
HQ SPCLT PHARMA |
Labeling |
Approval |
11/27/2019 |
FLUTICASONE PROPIONATE ANDA #207957 |
SUPPL-4 |
FLUTICASONE PROPIONATE |
HIKMA |
Labeling |
Approval |
11/27/2019 |
OZEMPIC NDA #209637 |
SUPPL-4 |
SEMAGLUTIDE |
NOVO |
Labeling |
Approval |
11/27/2019 |
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #209932 |
SUPPL-1 |
MAGNESIUM SULFATE |
MYLAN LABS LTD |
Labeling |
Approval |
11/27/2019 |
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER ANDA #209932 |
SUPPL-2 |
MAGNESIUM SULFATE |
MYLAN LABS LTD |
Labeling |
Approval |
11/27/2019 |
ALOGLIPTIN AND METFORMIN HYDROCHLORIDE ANDA #210212 |
ORIG-1 |
ALOGLIPTIN AND METFORMIN HYDROCHLORIDE |
MSN LABORATORIES PRIVATE LTD |
|
Tentative Approval |
11/27/2019 |
CELECOXIB ANDA #210628 |
ORIG-1 |
CELECOXIB |
UMEDICA |
|
Approval |
11/27/2019 |
REDITREX NDA #210737 |
ORIG-1 |
METHOTREXATE |
NORDIC GRP |
Type 5 - New Formulation or New Manufacturer |
Approval |
11/27/2019 |
REDITREX NDA #210737 |
ORIG-2 |
METHOTREXATE |
NORDIC GRP |
Efficacy |
Approval |
11/27/2019 |
SILDENAFIL CITRATE ANDA #211092 |
ORIG-1 |
SILDENAFIL CITRATE |
AMNEAL PHARMS |
|
Approval |
11/27/2019 |
QUZYTTIR NDA #211415 |
SUPPL-1 |
CETIRIZINE HYDROCHLORIDE |
JDP |
Labeling |
Approval |
11/27/2019 |
CHLORZOXAZONE ANDA #212253 |
ORIG-1 |
CHLORZOXAZONE |
NOVITIUM PHARMA |
|
Approval |
11/27/2019 |
SILDENAFIL CITRATE ANDA #212440 |
ORIG-1 |
SILDENAFIL CITRATE |
ALKEM LABS LTD |
|
Approval |
11/27/2019 |
SILDENAFIL CITRATE ANDA #212883 |
ORIG-1 |
SILDENAFIL CITRATE |
AJANTA PHARMA LTD |
|
Approval |
11/28/2019 |
BANZEL NDA #021911 |
SUPPL-17 |
RUFINAMIDE |
EISAI INC |
Labeling |
Approval |
11/28/2019 |
BANZEL NDA #201367 |
SUPPL-8 |
RUFINAMIDE |
EISAI INC |
Labeling |
Approval |
11/29/2019 |
ZIPRASIDONE HYDROCHLORIDE ANDA #077562 |
SUPPL-12 |
ZIPRASIDONE HYDROCHLORIDE |
SANDOZ INC |
Labeling |
Approval |
11/29/2019 |
ZIPRASIDONE HYDROCHLORIDE ANDA #077562 |
SUPPL-14 |
ZIPRASIDONE HYDROCHLORIDE |
SANDOZ INC |
Labeling |
Approval |
11/29/2019 |
ZIPRASIDONE HYDROCHLORIDE ANDA #077565 |
SUPPL-11 |
ZIPRASIDONE HYDROCHLORIDE |
DR REDDYS LABS INC |
Labeling |
Approval |
11/29/2019 |
ZIPRASIDONE HYDROCHLORIDE ANDA #077565 |
SUPPL-12 |
ZIPRASIDONE HYDROCHLORIDE |
DR REDDYS LABS INC |
Labeling |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #077903 |
SUPPL-23 |
ZOLPIDEM TARTRATE |
TORRENT PHARMS |
Labeling |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #077903 |
SUPPL-24 |
ZOLPIDEM TARTRATE |
TORRENT PHARMS |
Labeling |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #077903 |
SUPPL-25 |
ZOLPIDEM TARTRATE |
TORRENT PHARMS |
Labeling |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #077903 |
SUPPL-27 |
ZOLPIDEM TARTRATE |
TORRENT PHARMS |
Labeling |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #077903 |
SUPPL-28 |
ZOLPIDEM TARTRATE |
TORRENT PHARMS |
Labeling |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #077903 |
SUPPL-29 |
ZOLPIDEM TARTRATE |
TORRENT PHARMS |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #078908 |
SUPPL-8 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #078908 |
SUPPL-13 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #078970 |
SUPPL-5 |
ZOLPIDEM TARTRATE |
LUPIN LTD |
Labeling |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #078970 |
SUPPL-6 |
ZOLPIDEM TARTRATE |
LUPIN LTD |
Labeling |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #078970 |
SUPPL-7 |
ZOLPIDEM TARTRATE |
LUPIN LTD |
Labeling |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #078970 |
SUPPL-9 |
ZOLPIDEM TARTRATE |
LUPIN LTD |
Labeling |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #078970 |
SUPPL-10 |
ZOLPIDEM TARTRATE |
LUPIN LTD |
Labeling |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #078970 |
SUPPL-11 |
ZOLPIDEM TARTRATE |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #078970 |
SUPPL-12 |
ZOLPIDEM TARTRATE |
LUPIN LTD |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #078992 |
SUPPL-3 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
INTELLIPHARMACEUTICS |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #078992 |
SUPPL-4 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
INTELLIPHARMACEUTICS |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #079108 |
SUPPL-4 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
IMPAX LABS INC |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #079108 |
SUPPL-6 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
IMPAX LABS INC |
Labeling |
Approval |
11/29/2019 |
PREGABALIN ANDA #091157 |
ORIG-1 |
PREGABALIN |
SUN PHARM |
|
Approval |
11/29/2019 |
ANTHIM BLA #125509 |
SUPPL-15 |
OBILTOXAXIMAB |
ELUSYS THERAPEUTICS INC |
|
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #201231 |
SUPPL-3 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #201231 |
SUPPL-9 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
11/29/2019 |
TEMOZOLOMIDE ANDA #201528 |
SUPPL-3 |
TEMOZOLOMIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
11/29/2019 |
TEMOZOLOMIDE ANDA #201742 |
SUPPL-11 |
TEMOZOLOMIDE |
SUN PHARM |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #202580 |
SUPPL-4 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #202580 |
SUPPL-5 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #202731 |
SUPPL-5 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #202731 |
SUPPL-10 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #202842 |
SUPPL-1 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #202842 |
SUPPL-4 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
11/29/2019 |
RIZATRIPTAN BENZOATE ANDA #203146 |
SUPPL-17 |
RIZATRIPTAN BENZOATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/29/2019 |
RIZATRIPTAN BENZOATE ANDA #203147 |
SUPPL-15 |
RIZATRIPTAN BENZOATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
11/29/2019 |
TEMOZOLOMIDE ANDA #203490 |
SUPPL-3 |
TEMOZOLOMIDE |
ANI PHARMS |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #203614 |
SUPPL-2 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
IMPAX LABS INC |
Labeling |
Approval |
11/29/2019 |
DESVENLAFAXINE SUCCINATE ANDA #204065 |
SUPPL-2 |
DESVENLAFAXINE SUCCINATE |
ACTAVIS LABS FL |
Labeling |
Approval |
11/29/2019 |
DESVENLAFAXINE SUCCINATE ANDA #204065 |
SUPPL-5 |
DESVENLAFAXINE SUCCINATE |
ACTAVIS LABS FL |
Labeling |
Approval |
11/29/2019 |
RIZATRIPTAN BENZOATE ANDA #204090 |
SUPPL-1 |
RIZATRIPTAN BENZOATE |
AVET LIFESCIENCES |
Labeling |
Approval |
11/29/2019 |
RIZATRIPTAN BENZOATE ANDA #204090 |
SUPPL-2 |
RIZATRIPTAN BENZOATE |
AVET LIFESCIENCES |
Labeling |
Approval |
11/29/2019 |
ZIPRASIDONE HYDROCHLORIDE ANDA #204117 |
SUPPL-1 |
ZIPRASIDONE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/29/2019 |
ZIPRASIDONE HYDROCHLORIDE ANDA #204117 |
SUPPL-3 |
ZIPRASIDONE HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/29/2019 |
RABEPRAZOLE SODIUM ANDA #204237 |
SUPPL-2 |
RABEPRAZOLE SODIUM |
RUBICON |
Labeling |
Approval |
11/29/2019 |
RABEPRAZOLE SODIUM ANDA #204237 |
SUPPL-6 |
RABEPRAZOLE SODIUM |
RUBICON |
Labeling |
Approval |
11/29/2019 |
RABEPRAZOLE SODIUM ANDA #204237 |
SUPPL-8 |
RABEPRAZOLE SODIUM |
RUBICON |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #204266 |
SUPPL-3 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #204266 |
SUPPL-5 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
Labeling |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #204299 |
SUPPL-1 |
ZOLPIDEM TARTRATE |
NOVEL LABS INC |
Labeling |
Approval |
11/29/2019 |
ZOLPIDEM TARTRATE ANDA #204299 |
SUPPL-7 |
ZOLPIDEM TARTRATE |
NOVEL LABS INC |
Labeling |
Approval |
11/29/2019 |
RIZATRIPTAN BENZOATE ANDA #204339 |
SUPPL-3 |
RIZATRIPTAN BENZOATE |
INVAGEN PHARMS |
Labeling |
Approval |
11/29/2019 |
RIZATRIPTAN BENZOATE ANDA #204339 |
SUPPL-9 |
RIZATRIPTAN BENZOATE |
INVAGEN PHARMS |
Labeling |
Approval |
11/29/2019 |
TEMOZOLOMIDE ANDA #206413 |
SUPPL-1 |
TEMOZOLOMIDE |
CHARTWELL |
Labeling |
Approval |
11/29/2019 |
TEMOZOLOMIDE ANDA #206750 |
SUPPL-1 |
TEMOZOLOMIDE |
ZYDUS PHARMS |
Labeling |
Approval |
11/29/2019 |
ENOXAPARIN SODIUM (PRESERVATIVE FREE) ANDA #206834 |
ORIG-1 |
ENOXAPARIN SODIUM |
NANJING KING-FRIEND |
|
Approval |
11/29/2019 |
RIZATRIPTAN BENZOATE ANDA #207836 |
SUPPL-1 |
RIZATRIPTAN BENZOATE |
UNICHEM |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #207901 |
SUPPL-3 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TRIS PHARMA INC |
Labeling |
Approval |
11/29/2019 |
AMBRISENTAN ANDA #208252 |
SUPPL-1 |
AMBRISENTAN |
WATSON LABS INC |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #209468 |
SUPPL-2 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
LANNETT CO INC |
Labeling |
Approval |
11/29/2019 |
AMBRISENTAN ANDA #209509 |
SUPPL-1 |
AMBRISENTAN |
ENDO OPERATIONS |
Labeling |
Approval |
11/29/2019 |
TERIFLUNOMIDE ANDA #209613 |
SUPPL-1 |
TERIFLUNOMIDE |
AMNEAL PHARMS CO |
Labeling |
Approval |
11/29/2019 |
TERIFLUNOMIDE ANDA #209638 |
SUPPL-1 |
TERIFLUNOMIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/29/2019 |
TERIFLUNOMIDE ANDA #209638 |
SUPPL-2 |
TERIFLUNOMIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
11/29/2019 |
TERIFLUNOMIDE ANDA #209663 |
SUPPL-1 |
TERIFLUNOMIDE |
GLENMARK SPECLT |
Labeling |
Approval |
11/29/2019 |
DEXMETHYLPHENIDATE HYDROCHLORIDE ANDA #210279 |
SUPPL-2 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
ADARE PHARMS INC |
Labeling |
Approval |
11/29/2019 |
SODIUM NITROPRUSSIDE ANDA #211016 |
ORIG-1 |
SODIUM NITROPRUSSIDE |
CAPLIN |
|
Approval |
11/29/2019 |
TRIAMCINOLONE ACETONIDE ANDA #212384 |
ORIG-1 |
TRIAMCINOLONE ACETONIDE |
ENCUBE |
|
Approval |