09/03/2019 |
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ANDA #090528 |
SUPPL-19 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
TORRENT PHARMS |
Labeling |
Approval |
09/03/2019 |
LOSARTAN POTASSIUM ANDA #091129 |
SUPPL-8 |
LOSARTAN POTASSIUM |
WATSON LABS |
Labeling |
Approval |
09/03/2019 |
LOSARTAN POTASSIUM ANDA #200290 |
SUPPL-3 |
LOSARTAN POTASSIUM |
IPCA LABS LTD |
Labeling |
Approval |
09/03/2019 |
LOSARTAN POTASSIUM ANDA #200290 |
SUPPL-4 |
LOSARTAN POTASSIUM |
IPCA LABS LTD |
Labeling |
Approval |
09/03/2019 |
VALSARTAN ANDA #201677 |
SUPPL-3 |
VALSARTAN |
LUPIN LTD |
Labeling |
Approval |
09/03/2019 |
VALSARTAN ANDA #201677 |
SUPPL-4 |
VALSARTAN |
LUPIN LTD |
Labeling |
Approval |
09/03/2019 |
VALSARTAN ANDA #205347 |
SUPPL-1 |
VALSARTAN |
SQUARE PHARMS |
Labeling |
Approval |
09/03/2019 |
LATANOPROST ANDA #206519 |
ORIG-1 |
LATANOPROST |
EUGIA PHARMA |
|
Approval |
09/03/2019 |
METHYLPHENIDATE HYDROCHLORIDE ANDA #211009 |
ORIG-1 |
METHYLPHENIDATE HYDROCHLORIDE |
ASCENT PHARMS INC |
|
Approval |
09/04/2019 |
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #018916 |
SUPPL-63 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45% NDA #018916 |
SUPPL-63 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9% NDA #018916 |
SUPPL-63 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018916 |
SUPPL-63 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9% NDA #018916 |
SUPPL-63 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #018916 |
SUPPL-63 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER NDA #018916 |
SUPPL-63 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER NDA #018916 |
SUPPL-63 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45% NDA #018916 |
SUPPL-63 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% NDA #018916 |
SUPPL-63 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #019339 |
SUPPL-52 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #019339 |
SUPPL-52 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #019339 |
SUPPL-52 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #019805 |
SUPPL-34 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #019805 |
SUPPL-34 |
HEPARIN SODIUM |
HOSPIRA |
Labeling |
Approval |
09/04/2019 |
GLYCOPYRROLATE ANDA #089335 |
SUPPL-23 |
GLYCOPYRROLATE |
AM REGENT |
Labeling |
Approval |
09/04/2019 |
VALSARTAN ANDA #202696 |
SUPPL-13 |
VALSARTAN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/04/2019 |
UPTRAVI NDA #207947 |
SUPPL-7 |
SELEXIPAG |
ACTELION |
Labeling |
Approval |
09/04/2019 |
LURASIDONE HYDROCHLORIDE ANDA #208058 |
ORIG-1 |
LURASIDONE HYDROCHLORIDE |
AVET LIFESCIENCES |
|
Approval |
09/05/2019 |
SULFAMETHOXAZOLE AND TRIMETHOPRIM NDA #018598 |
SUPPL-52 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
FOSUN PHARMA |
Labeling |
Approval |
09/05/2019 |
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH NDA #018598 |
SUPPL-52 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
FOSUN PHARMA |
Labeling |
Approval |
09/05/2019 |
PARAGARD T 380A NDA #018680 |
SUPPL-69 |
COPPER |
COOPERSURGICAL |
Labeling |
Approval |
09/05/2019 |
PARAGARD T 380A NDA #018680 |
SUPPL-70 |
COPPER |
COOPERSURGICAL |
Labeling |
Approval |
09/05/2019 |
REMERON NDA #020415 |
SUPPL-35 |
MIRTAZAPINE |
ORGANON |
Labeling |
Approval |
09/05/2019 |
REMERON SOLTAB NDA #021208 |
SUPPL-25 |
MIRTAZAPINE |
ORGANON USA ORGANON |
Labeling |
Approval |
09/05/2019 |
METHYLPREDNISOLONE ANDA #040183 |
SUPPL-18 |
METHYLPREDNISOLONE |
ENDO OPERATIONS |
Labeling |
Approval |
09/05/2019 |
CLINDA-DERM ANDA #063329 |
SUPPL-6 |
CLINDAMYCIN PHOSPHATE |
PADAGIS US |
Labeling |
Approval |
09/05/2019 |
ANASTROZOLE ANDA #078921 |
SUPPL-8 |
ANASTROZOLE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
09/05/2019 |
VALSARTAN AND HYDROCHLOROTHIAZIDE ANDA #078946 |
SUPPL-6 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
LUPIN LTD |
Labeling |
Approval |
09/05/2019 |
VALSARTAN AND HYDROCHLOROTHIAZIDE ANDA #078946 |
SUPPL-7 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
LUPIN LTD |
Labeling |
Approval |
09/05/2019 |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) ANDA #079198 |
SUPPL-7 |
OCTREOTIDE ACETATE |
MYLAN INSTITUTIONAL |
Labeling |
Approval |
09/05/2019 |
METFORMIN HYDROCHLORIDE ANDA #091664 |
SUPPL-2 |
METFORMIN HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
09/05/2019 |
METFORMIN HYDROCHLORIDE ANDA #091664 |
SUPPL-6 |
METFORMIN HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
09/05/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #202410 |
SUPPL-1 |
DONEPEZIL HYDROCHLORIDE |
HISUN PHARM HANGZHOU |
Labeling |
Approval |
09/05/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #202656 |
SUPPL-2 |
DONEPEZIL HYDROCHLORIDE |
RISING |
Labeling |
Approval |
09/05/2019 |
FOSAPREPITANT DIMEGLUMINE ANDA #204015 |
ORIG-1 |
FOSAPREPITANT DIMEGLUMINE |
MYLAN LABS LTD |
|
Approval |
09/05/2019 |
FOSAPREPITANT DIMEGLUMINE ANDA #205020 |
ORIG-1 |
FOSAPREPITANT DIMEGLUMINE |
APOTEX |
|
Approval |
09/05/2019 |
BUSULFAN ANDA #205184 |
SUPPL-1 |
BUSULFAN |
MYLAN LABS LTD |
Labeling |
Approval |
09/05/2019 |
CASPOFUNGIN ACETATE ANDA #207092 |
SUPPL-1 |
CASPOFUNGIN ACETATE |
GLAND |
Labeling |
Approval |
09/05/2019 |
CASPOFUNGIN ACETATE ANDA #207092 |
SUPPL-3 |
CASPOFUNGIN ACETATE |
GLAND |
Labeling |
Approval |
09/05/2019 |
DOXYCYCLINE HYCLATE ANDA #207289 |
SUPPL-1 |
DOXYCYCLINE HYCLATE |
AMNEAL PHARMS |
Labeling |
Approval |
09/05/2019 |
DOXYCYCLINE HYCLATE ANDA #207289 |
SUPPL-3 |
DOXYCYCLINE HYCLATE |
AMNEAL PHARMS |
Labeling |
Approval |
09/05/2019 |
DOXYCYCLINE HYCLATE ANDA #207289 |
SUPPL-6 |
DOXYCYCLINE HYCLATE |
AMNEAL PHARMS |
Labeling |
Approval |
09/05/2019 |
DOXYCYCLINE HYCLATE ANDA #207774 |
SUPPL-1 |
DOXYCYCLINE HYCLATE |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
09/05/2019 |
DOCETAXEL ANDA #208859 |
SUPPL-2 |
DOCETAXEL |
MYLAN LABS LTD |
Labeling |
Approval |
09/05/2019 |
FOSAPREPITANT DIMEGLUMINE ANDA #209965 |
ORIG-1 |
FOSAPREPITANT DIMEGLUMINE |
MSN |
|
Approval |
09/05/2019 |
FOSAPREPITANT DIMEGLUMINE NDA #210064 |
ORIG-1 |
FOSAPREPITANT DIMEGLUMINE |
TEVA PHARMS USA |
Type 5 - New Formulation or New Manufacturer |
Approval |
09/05/2019 |
DOCETAXEL ANDA #210072 |
SUPPL-3 |
DOCETAXEL |
MYLAN LABS LTD |
Labeling |
Approval |
09/05/2019 |
FOSAPREPITANT DIMEGLUMINE ANDA #210689 |
ORIG-1 |
FOSAPREPITANT DIMEGLUMINE |
LUPIN LTD |
|
Approval |
09/05/2019 |
DOCETAXEL ANDA #210848 |
SUPPL-2 |
DOCETAXEL |
MYLAN LABS LTD |
Labeling |
Approval |
09/05/2019 |
DOXYCYCLINE HYCLATE ANDA #211012 |
SUPPL-1 |
DOXYCYCLINE HYCLATE |
AJANTA PHARMA LTD |
Labeling |
Approval |
09/05/2019 |
BUPROPION HYDROCHLORIDE ANDA #211200 |
ORIG-1 |
BUPROPION HYDROCHLORIDE |
ZHEJIANG JUTAI PHARM |
|
Approval |
09/05/2019 |
FOSAPREPITANT DIMEGLUMINE ANDA #211624 |
ORIG-1 |
FOSAPREPITANT DIMEGLUMINE |
ARTHUR GRP |
|
Approval |
09/05/2019 |
FOSAPREPITANT DIMEGLUMINE ANDA #211860 |
ORIG-1 |
FOSAPREPITANT DIMEGLUMINE |
BAXTER HLTHCARE CORP |
|
Approval |
09/05/2019 |
FOSAPREPITANT DIMEGLUMINE ANDA #212309 |
ORIG-1 |
FOSAPREPITANT DIMEGLUMINE |
BE PHARMS |
|
Approval |
09/05/2019 |
ASPARLAS BLA #761102 |
SUPPL-2 |
CALASPARGASE PEGOL-MKNL |
SERVIER PHARMA LLC |
|
Approval |
09/06/2019 |
PULMICORT RESPULES NDA #020929 |
SUPPL-52 |
BUDESONIDE |
ASTRAZENECA |
Labeling |
Approval |
09/06/2019 |
VIVITROL NDA #021897 |
SUPPL-45 |
NALTREXONE |
ALKERMES |
Labeling |
Approval |
09/06/2019 |
PULMICORT FLEXHALER NDA #021949 |
SUPPL-13 |
BUDESONIDE |
ASTRAZENECA |
Labeling |
Approval |
09/06/2019 |
ADVIL ALLERGY AND CONGESTION RELIEF NDA #022113 |
SUPPL-8 |
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE |
HALEON US HOLDINGS |
Labeling |
Approval |
09/06/2019 |
ADVIL MULTI-SYMPTOM COLD & FLU NDA #022113 |
SUPPL-8 |
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE |
HALEON US HOLDINGS |
Labeling |
Approval |
09/06/2019 |
KEFLEX NDA #050405 |
SUPPL-110 |
CEPHALEXIN |
PRAGMA |
Labeling |
Approval |
09/06/2019 |
TEMAZEPAM ANDA #071427 |
SUPPL-30 |
TEMAZEPAM |
CHARTWELL RX |
Labeling |
Approval |
09/06/2019 |
TEMAZEPAM ANDA #071427 |
SUPPL-31 |
TEMAZEPAM |
CHARTWELL RX |
Labeling |
Approval |
09/06/2019 |
TEMAZEPAM ANDA #071428 |
SUPPL-30 |
TEMAZEPAM |
CHARTWELL RX |
Labeling |
Approval |
09/06/2019 |
TEMAZEPAM ANDA #071428 |
SUPPL-31 |
TEMAZEPAM |
CHARTWELL RX |
Labeling |
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #074248 |
SUPPL-24 |
CLOBETASOL PROPIONATE |
TARO |
Labeling |
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #074249 |
SUPPL-28 |
CLOBETASOL PROPIONATE |
TARO |
Labeling |
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #075279 |
SUPPL-13 |
CLOBETASOL PROPIONATE |
TARO |
Labeling |
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #075391 |
SUPPL-12 |
CLOBETASOL PROPIONATE |
FOUGERA PHARMS |
Labeling |
Approval |
09/06/2019 |
MESNA ANDA #075764 |
SUPPL-28 |
MESNA |
TEVA PHARMS USA |
Labeling |
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #076977 |
SUPPL-11 |
CLOBETASOL PROPIONATE |
ENCUBE |
Labeling |
Approval |
09/06/2019 |
VALSARTAN AND HYDROCHLOROTHIAZIDE ANDA #078020 |
SUPPL-13 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
MYLAN PHARMS INC |
Labeling |
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #090898 |
SUPPL-4 |
CLOBETASOL PROPIONATE |
PADAGIS US |
Labeling |
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #090898 |
SUPPL-6 |
CLOBETASOL PROPIONATE |
PADAGIS US |
Labeling |
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #090974 |
SUPPL-5 |
CLOBETASOL PROPIONATE |
PADAGIS ISRAEL |
Labeling |
Approval |
09/06/2019 |
CIMZIA BLA #125160 |
SUPPL-293 |
CERTOLIZUMAB PEGOL |
UCB INC |
|
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #200302 |
SUPPL-2 |
CLOBETASOL PROPIONATE |
TARO |
Labeling |
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #201402 |
SUPPL-2 |
CLOBETASOL PROPIONATE |
PADAGIS ISRAEL |
Labeling |
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #201402 |
SUPPL-13 |
CLOBETASOL PROPIONATE |
PADAGIS ISRAEL |
Labeling |
Approval |
09/06/2019 |
AUBAGIO NDA #202992 |
SUPPL-8 |
TERIFLUNOMIDE |
SANOFI AVENTIS US |
Labeling |
Approval |
09/06/2019 |
MEROPENEM ANDA #204139 |
SUPPL-1 |
MEROPENEM |
ACS DOBFAR SPA |
Labeling |
Approval |
09/06/2019 |
OFEV NDA #205832 |
SUPPL-12 |
NINTEDANIB ESYLATE |
BOEHRINGER INGELHEIM |
Efficacy |
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #206378 |
SUPPL-3 |
CLOBETASOL PROPIONATE |
ZYDUS PHARMS |
Labeling |
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #206805 |
SUPPL-1 |
CLOBETASOL PROPIONATE |
NOVAST LABS |
Labeling |
Approval |
09/06/2019 |
MESNA ANDA #206992 |
SUPPL-1 |
MESNA |
GLAND |
Labeling |
Approval |
09/06/2019 |
MESNA ANDA #206992 |
SUPPL-3 |
MESNA |
GLAND |
Labeling |
Approval |
09/06/2019 |
DOCETAXEL ANDA #207563 |
SUPPL-2 |
DOCETAXEL |
NOVAST LABS |
Labeling |
Approval |
09/06/2019 |
DOCETAXEL ANDA #207563 |
SUPPL-4 |
DOCETAXEL |
NOVAST LABS |
Labeling |
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #208125 |
SUPPL-1 |
CLOBETASOL PROPIONATE |
LUPIN LTD |
Labeling |
Approval |
09/06/2019 |
CLOBETASOL PROPIONATE ANDA #208667 |
SUPPL-1 |
CLOBETASOL PROPIONATE |
PAI HOLDINGS PHARM |
Labeling |
Approval |
09/06/2019 |
COLCHICINE ANDA #209876 |
ORIG-1 |
COLCHICINE |
DR REDDYS |
|
Approval |
09/06/2019 |
FENOFIBRATE ANDA #210670 |
ORIG-1 |
FENOFIBRATE |
DR REDDYS |
|
Approval |
09/06/2019 |
NICOTINE POLACRILEX ANDA #210712 |
ORIG-1 |
NICOTINE POLACRILEX |
P AND L |
|
Approval |
09/06/2019 |
ACYCLOVIR ANDA #210774 |
ORIG-1 |
ACYCLOVIR |
APOTEX |
|
Approval |
09/06/2019 |
ETHACRYNIC ACID ANDA #211719 |
ORIG-1 |
ETHACRYNIC ACID |
LUPIN LTD |
|
Approval |
09/06/2019 |
ALBUTEROL SULFATE ANDA #212197 |
ORIG-1 |
ALBUTEROL SULFATE |
QUAGEN |
|
Approval |
09/06/2019 |
CLOBAZAM ANDA #212714 |
ORIG-1 |
CLOBAZAM |
ALKEM LABS LTD |
|
Approval |
09/09/2019 |
PRAVASTATIN SODIUM ANDA #077491 |
SUPPL-5 |
PRAVASTATIN SODIUM |
APNAR PHARMA LP |
Labeling |
Approval |
09/09/2019 |
RALOXIFENE HYDROCHLORIDE ANDA #078193 |
SUPPL-5 |
RALOXIFENE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
09/09/2019 |
RALOXIFENE HYDROCHLORIDE ANDA #078193 |
SUPPL-8 |
RALOXIFENE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
09/09/2019 |
TAMSULOSIN HYDROCHLORIDE ANDA #078225 |
SUPPL-14 |
TAMSULOSIN HYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
09/09/2019 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ANDA #078267 |
SUPPL-9 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
AMNEAL PHARMS |
Labeling |
Approval |
09/09/2019 |
OXYBUTYNIN CHLORIDE ANDA #078503 |
SUPPL-7 |
OXYBUTYNIN CHLORIDE |
OSMOTICA PHARM US |
Labeling |
Approval |
09/09/2019 |
OXYBUTYNIN CHLORIDE ANDA #078503 |
SUPPL-9 |
OXYBUTYNIN CHLORIDE |
OSMOTICA PHARM US |
Labeling |
Approval |
09/09/2019 |
TAMSULOSIN HYDROCHLORIDE ANDA #090931 |
SUPPL-10 |
TAMSULOSIN HYDROCHLORIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
09/09/2019 |
TRAMADOL HYDROCHLORIDE ANDA #201384 |
SUPPL-10 |
TRAMADOL HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
09/09/2019 |
AZACITIDINE ANDA #201537 |
SUPPL-8 |
AZACITIDINE |
DR REDDYS |
Labeling |
Approval |
09/09/2019 |
GLUCAGON NDA #201849 |
SUPPL-5 |
GLUCAGON HYDROCHLORIDE |
FRESENIUS KABI USA |
Efficacy |
Approval |
09/09/2019 |
TAMSULOSIN HYDROCHLORIDE ANDA #202433 |
SUPPL-12 |
TAMSULOSIN HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/09/2019 |
TELMISARTAN AND AMLODIPINE ANDA #202516 |
SUPPL-4 |
AMLODIPINE BESYLATE; TELMISARTAN |
MYLAN |
Labeling |
Approval |
09/09/2019 |
TELMISARTAN AND AMLODIPINE ANDA #202516 |
SUPPL-6 |
AMLODIPINE BESYLATE; TELMISARTAN |
MYLAN |
Labeling |
Approval |
09/09/2019 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #203863 |
SUPPL-2 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
EPIC PHARMA LLC |
Labeling |
Approval |
09/09/2019 |
PROCHLORPERAZINE EDISYLATE ANDA #204147 |
SUPPL-21 |
PROCHLORPERAZINE EDISYLATE |
AVET LIFESCIENCES |
Manufacturing (CMC) |
Approval |
09/09/2019 |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE ANDA #205397 |
ORIG-1 |
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE |
PADAGIS ISRAEL |
|
Approval |
09/09/2019 |
SIVEXTRO NDA #205435 |
SUPPL-11 |
TEDIZOLID PHOSPHATE |
CUBIST PHARMS LLC |
Labeling |
Approval |
09/09/2019 |
SIVEXTRO NDA #205436 |
SUPPL-6 |
TEDIZOLID PHOSPHATE |
CUBIST PHARMS LLC |
Labeling |
Approval |
09/09/2019 |
MIBELAS 24 FE ANDA #206287 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
LUPIN |
Labeling |
Approval |
09/09/2019 |
MIBELAS 24 FE ANDA #206287 |
SUPPL-6 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
LUPIN |
Labeling |
Approval |
09/09/2019 |
MIBELAS 24 FE ANDA #206287 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
LUPIN |
Manufacturing (CMC) |
Approval |
09/09/2019 |
CELECOXIB ANDA #206827 |
SUPPL-6 |
CELECOXIB |
AUROBINDO PHARMA |
Labeling |
Approval |
09/09/2019 |
IBRANCE NDA #207103 |
SUPPL-11 |
PALBOCICLIB |
PFIZER |
Efficacy |
Approval |
09/09/2019 |
IBRANCE NDA #207103 |
SUPPL-12 |
PALBOCICLIB |
PFIZER |
Labeling |
Approval |
09/09/2019 |
VERZENIO NDA #208716 |
SUPPL-3 |
ABEMACICLIB |
ELI LILLY AND CO |
Labeling |
Approval |
09/09/2019 |
KISQALI NDA #209092 |
SUPPL-4 |
RIBOCICLIB SUCCINATE |
NOVARTIS |
Labeling |
Approval |
09/09/2019 |
CARFILZOMIB ANDA #209422 |
ORIG-1 |
CARFILZOMIB |
DR REDDYS |
|
Approval |
09/09/2019 |
KISQALI FEMARA CO-PACK (COPACKAGED) NDA #209935 |
SUPPL-7 |
LETROZOLE; RIBOCICLIB SUCCINATE |
NOVARTIS |
Labeling |
Approval |
09/09/2019 |
CLOBETASOL PROPIONATE ANDA #211450 |
ORIG-1 |
CLOBETASOL PROPIONATE |
GLENMARK PHARMS LTD |
|
Approval |
09/10/2019 |
ALTABAX NDA #022055 |
SUPPL-7 |
RETAPAMULIN |
ALMIRALL |
Labeling |
Approval |
09/10/2019 |
MYCOPHENOLATE MOFETIL ANDA #065491 |
SUPPL-17 |
MYCOPHENOLATE MOFETIL |
TEVA PHARMS |
Labeling |
Approval |
09/10/2019 |
MYCOPHENOLATE MOFETIL ANDA #065491 |
SUPPL-18 |
MYCOPHENOLATE MOFETIL |
TEVA PHARMS |
Labeling |
Approval |
09/10/2019 |
MYCOPHENOLATE MOFETIL ANDA #091249 |
SUPPL-14 |
MYCOPHENOLATE MOFETIL |
ALKEM LABS LTD |
Labeling |
Approval |
09/10/2019 |
MYCOPHENOLATE MOFETIL ANDA #091249 |
SUPPL-16 |
MYCOPHENOLATE MOFETIL |
ALKEM LABS LTD |
Labeling |
Approval |
09/10/2019 |
MYCOPHENOLATE MOFETIL ANDA #200197 |
SUPPL-11 |
MYCOPHENOLATE MOFETIL |
ALKEM LABS LTD |
Labeling |
Approval |
09/10/2019 |
MYCOPHENOLATE MOFETIL ANDA #200197 |
SUPPL-13 |
MYCOPHENOLATE MOFETIL |
ALKEM LABS LTD |
Labeling |
Approval |
09/10/2019 |
VALSARTAN AND HYDROCHLOROTHIAZIDE ANDA #201662 |
SUPPL-19 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
ALEMBIC |
Labeling |
Approval |
09/10/2019 |
ACZONE NDA #207154 |
SUPPL-4 |
DAPSONE |
ALMIRALL |
Efficacy |
Approval |
09/10/2019 |
APIXABAN ANDA #209944 |
ORIG-1 |
APIXABAN |
SUNSHINE LAKE |
|
Tentative Approval |
09/10/2019 |
VORTIOXETINE ANDA #210953 |
ORIG-1 |
VORTIOXETINE |
AMNEAL PHARMS CO |
|
Tentative Approval |
09/10/2019 |
GVOKE HYPOPEN NDA #212097 |
ORIG-1 |
GLUCAGON |
XERIS |
Type 3 - New Dosage Form |
Approval |
09/10/2019 |
GVOKE KIT NDA #212097 |
ORIG-1 |
GLUCAGON |
XERIS |
Type 3 - New Dosage Form |
Approval |
09/10/2019 |
GVOKE PFS NDA #212097 |
ORIG-1 |
GLUCAGON |
XERIS |
Type 3 - New Dosage Form |
Approval |
09/10/2019 |
ACETAMINOPHEN AND CODEINE PHOSPHATE ANDA #212418 |
ORIG-1 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
ELITE LABS INC |
|
Approval |
09/11/2019 |
PAXIL CR NDA #020936 |
SUPPL-47 |
PAROXETINE HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
09/11/2019 |
MYCOPHENOLATE MOFETIL ANDA #065379 |
SUPPL-22 |
MYCOPHENOLATE MOFETIL |
SANDOZ |
Labeling |
Approval |
09/11/2019 |
MYCOPHENOLATE MOFETIL ANDA #065379 |
SUPPL-24 |
MYCOPHENOLATE MOFETIL |
SANDOZ |
Labeling |
Approval |
09/11/2019 |
MYCOPHENOLATE MOFETIL ANDA #065416 |
SUPPL-16 |
MYCOPHENOLATE MOFETIL |
ACCORD HLTHCARE |
Labeling |
Approval |
09/11/2019 |
MYCOPHENOLATE MOFETIL ANDA #065451 |
SUPPL-22 |
MYCOPHENOLATE MOFETIL |
SANDOZ |
Labeling |
Approval |
09/11/2019 |
MYCOPHENOLATE MOFETIL ANDA #065451 |
SUPPL-25 |
MYCOPHENOLATE MOFETIL |
SANDOZ |
Labeling |
Approval |
09/11/2019 |
MYCOPHENOLATE MOFETIL ANDA #065520 |
SUPPL-20 |
MYCOPHENOLATE MOFETIL |
MYLAN |
Labeling |
Approval |
09/11/2019 |
MYCOPHENOLATE MOFETIL ANDA #065520 |
SUPPL-22 |
MYCOPHENOLATE MOFETIL |
MYLAN |
Labeling |
Approval |
09/11/2019 |
MYCOPHENOLATE MOFETIL ANDA #065521 |
SUPPL-18 |
MYCOPHENOLATE MOFETIL |
MYLAN |
Labeling |
Approval |
09/11/2019 |
MYCOPHENOLATE MOFETIL ANDA #065521 |
SUPPL-20 |
MYCOPHENOLATE MOFETIL |
MYLAN |
Labeling |
Approval |
09/11/2019 |
AMANTADINE HYDROCHLORIDE ANDA #071293 |
SUPPL-38 |
AMANTADINE HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
09/11/2019 |
AMANTADINE HYDROCHLORIDE ANDA #071293 |
SUPPL-40 |
AMANTADINE HYDROCHLORIDE |
SANDOZ |
Manufacturing (CMC) |
Approval |
09/11/2019 |
INDOMETHACIN ANDA #073314 |
SUPPL-22 |
INDOMETHACIN |
COSETTE |
Labeling |
Approval |
09/11/2019 |
INDOMETHACIN ANDA #073314 |
SUPPL-23 |
INDOMETHACIN |
COSETTE |
Labeling |
Approval |
09/11/2019 |
OXAPROZIN ANDA #075855 |
SUPPL-8 |
OXAPROZIN |
DR REDDYS LABS LTD |
Labeling |
Approval |
09/11/2019 |
OXAPROZIN ANDA #075855 |
SUPPL-9 |
OXAPROZIN |
DR REDDYS LABS LTD |
Labeling |
Approval |
09/11/2019 |
MYCOPHENOLATE MOFETIL ANDA #090253 |
SUPPL-16 |
MYCOPHENOLATE MOFETIL |
ACCORD HLTHCARE |
Labeling |
Approval |
09/11/2019 |
FAMOTIDINE ANDA #206531 |
SUPPL-1 |
FAMOTIDINE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/11/2019 |
FAMOTIDINE ANDA #206531 |
SUPPL-7 |
FAMOTIDINE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/11/2019 |
BACLOFEN ANDA #210048 |
ORIG-1 |
BACLOFEN |
MAIA PHARMS INC |
|
Approval |
09/11/2019 |
DOLUTEGAVIR; LAMIVUDINE; TENOFOVIR ALAFENAMIDE FUMARATE NDA #210865 |
ORIG-1 |
DOLUTEGAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE FUMARATE |
MYLAN LABS LTD |
Type 4 - New Combination |
Tentative Approval |
09/11/2019 |
DAPAGLIFLOZIN ANDA #211482 |
ORIG-1 |
DAPAGLIFLOZIN |
AJANTA PHARMA LTD |
|
Tentative Approval |
09/12/2019 |
SABRIL NDA #020427 |
SUPPL-22 |
VIGABATRIN |
LUNDBECK PHARMS LLC |
REMS |
Approval |
09/12/2019 |
DITROPAN XL NDA #020897 |
SUPPL-37 |
OXYBUTYNIN CHLORIDE |
JANSSEN PHARMS |
Labeling |
Approval |
09/12/2019 |
SABRIL NDA #022006 |
SUPPL-24 |
VIGABATRIN |
LUNDBECK PHARMS LLC |
REMS |
Approval |
09/12/2019 |
NUCALA BLA #125526 |
SUPPL-12 |
MEPOLIZUMAB |
GLAXOSMITHKLINE LLC |
|
Approval |
09/12/2019 |
CLOPIDOGREL BISULFATE ANDA #203751 |
SUPPL-2 |
CLOPIDOGREL BISULFATE |
AMNEAL PHARMS |
Labeling |
Approval |
09/12/2019 |
CLOPIDOGREL BISULFATE ANDA #203751 |
SUPPL-3 |
CLOPIDOGREL BISULFATE |
AMNEAL PHARMS |
Labeling |
Approval |
09/12/2019 |
CLOPIDOGREL BISULFATE ANDA #203751 |
SUPPL-4 |
CLOPIDOGREL BISULFATE |
AMNEAL PHARMS |
Labeling |
Approval |
09/12/2019 |
CLOPIDOGREL BISULFATE ANDA #203751 |
SUPPL-5 |
CLOPIDOGREL BISULFATE |
AMNEAL PHARMS |
Labeling |
Approval |
09/12/2019 |
VIGABATRIN ANDA #208218 |
SUPPL-7 |
VIGABATRIN |
ENDO OPERATIONS |
REMS |
Approval |
09/12/2019 |
VIGABATRIN ANDA #209822 |
SUPPL-4 |
VIGABATRIN |
TEVA PHARMS USA |
REMS |
Approval |
09/12/2019 |
VIGABATRIN ANDA #209824 |
SUPPL-5 |
VIGABATRIN |
TEVA PHARMS USA |
REMS |
Approval |
09/12/2019 |
VIGABATRIN ANDA #210155 |
SUPPL-4 |
VIGABATRIN |
AMNEAL PHARMS |
REMS |
Approval |
09/12/2019 |
VIGADRONE ANDA #210196 |
SUPPL-3 |
VIGABATRIN |
AUCTA |
REMS |
Approval |
09/12/2019 |
VIGABATRIN ANDA #211481 |
SUPPL-2 |
VIGABATRIN |
DR REDDYS |
REMS |
Approval |
09/12/2019 |
IBSRELA NDA #211801 |
ORIG-1 |
TENAPANOR HYDROCHLORIDE |
ARDELYX INC |
Type 1 - New Molecular Entity |
Approval |
09/12/2019 |
CHLORZOXAZONE ANDA #212254 |
ORIG-1 |
CHLORZOXAZONE |
NOVITIUM PHARMA |
|
Approval |
09/12/2019 |
NUCALA BLA #761122 |
SUPPL-2 |
MEPOLIZUMAB |
GLAXOSMITHKLINE |
|
Approval |
09/12/2019 |
NUCALA BLA #761122 |
SUPPL-3 |
MEPOLIZUMAB |
GLAXOSMITHKLINE |
|
Approval |
09/13/2019 |
MYDAYIS NDA #022063 |
SUPPL-1 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
TAKEDA PHARMS USA |
Efficacy |
Approval |
09/13/2019 |
ANASTROZOLE ANDA #091051 |
SUPPL-7 |
ANASTROZOLE |
MYLAN |
Labeling |
Approval |
09/13/2019 |
VALSARTAN ANDA #091367 |
SUPPL-5 |
VALSARTAN |
ALEMBIC |
Labeling |
Approval |
09/13/2019 |
VALSARTAN ANDA #091367 |
SUPPL-11 |
VALSARTAN |
ALEMBIC |
Labeling |
Approval |
09/13/2019 |
BENLYSTA BLA #125370 |
SUPPL-67 |
BELIMUMAB |
HUMAN GENOME SCIENCES INC. |
|
Approval |
09/13/2019 |
TEFLARO NDA #200327 |
SUPPL-22 |
CEFTAROLINE FOSAMIL |
ABBVIE |
Efficacy |
Approval |
09/13/2019 |
PANTOPRAZOLE SODIUM ANDA #200821 |
SUPPL-8 |
PANTOPRAZOLE SODIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/13/2019 |
PANTOPRAZOLE SODIUM ANDA #200821 |
SUPPL-10 |
PANTOPRAZOLE SODIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/13/2019 |
PANTOPRAZOLE SODIUM ANDA #200821 |
SUPPL-12 |
PANTOPRAZOLE SODIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/13/2019 |
PANTOPRAZOLE SODIUM ANDA #200821 |
SUPPL-15 |
PANTOPRAZOLE SODIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/13/2019 |
PANTOPRAZOLE SODIUM ANDA #200821 |
SUPPL-19 |
PANTOPRAZOLE SODIUM |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/13/2019 |
TRANEXAMIC ACID ANDA #202436 |
SUPPL-3 |
TRANEXAMIC ACID |
ACIC PHARMS |
Labeling |
Approval |
09/13/2019 |
LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #205564 |
SUPPL-5 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/13/2019 |
LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #205564 |
SUPPL-10 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/13/2019 |
LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #205564 |
SUPPL-13 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/13/2019 |
COLESEVELAM HYDROCHLORIDE ANDA #208670 |
ORIG-1 |
COLESEVELAM HYDROCHLORIDE |
BIONPHARMA |
|
Approval |
09/13/2019 |
IVERMECTIN ANDA #210019 |
ORIG-1 |
IVERMECTIN |
TEVA PHARMS USA |
|
Approval |
09/13/2019 |
ZULRESSO NDA #211371 |
SUPPL-2 |
BREXANOLONE |
SAGE THERAP |
Labeling |
Approval |
09/13/2019 |
MELPHALAN HYDROCHLORIDE ANDA #211463 |
ORIG-1 |
MELPHALAN HYDROCHLORIDE |
ARTHUR GRP |
|
Approval |
09/13/2019 |
DOLUTEGRAVIR SODIUM ANDA #212179 |
ORIG-1 |
DOLUTEGRAVIR SODIUM |
MICRO LABS LTD |
|
Tentative Approval |
09/13/2019 |
DOXEPIN HYDROCHLORIDE ANDA #212624 |
ORIG-1 |
DOXEPIN HYDROCHLORIDE |
AJANTA PHARMA LTD |
|
Approval |
09/13/2019 |
NADOLOL ANDA #212856 |
ORIG-1 |
NADOLOL |
RK PHARMA |
|
Approval |
09/13/2019 |
BENLYSTA BLA #761043 |
SUPPL-5 |
BELIMUMAB |
GLAXOSMITHKLINE LLC |
|
Approval |
09/13/2019 |
CYLTEZO BLA #761058 |
SUPPL-3 |
ADALIMUMAB-ADBM |
BOEHRINGER INGELHEIM |
|
Approval |
09/15/2019 |
MESNA ANDA #075811 |
SUPPL-14 |
MESNA |
FRESENIUS KABI USA |
Labeling |
Approval |
09/16/2019 |
CLEOCIN NDA #050767 |
SUPPL-16 |
CLINDAMYCIN PHOSPHATE |
PFIZER |
Labeling |
Approval |
09/16/2019 |
PANTOPRAZOLE SODIUM ANDA #090296 |
SUPPL-2 |
PANTOPRAZOLE SODIUM |
SANDOZ |
Labeling |
Approval |
09/16/2019 |
PANTOPRAZOLE SODIUM ANDA #090296 |
SUPPL-3 |
PANTOPRAZOLE SODIUM |
SANDOZ |
Labeling |
Approval |
09/16/2019 |
PANTOPRAZOLE SODIUM ANDA #090296 |
SUPPL-5 |
PANTOPRAZOLE SODIUM |
SANDOZ |
Labeling |
Approval |
09/16/2019 |
PANTOPRAZOLE SODIUM ANDA #090296 |
SUPPL-6 |
PANTOPRAZOLE SODIUM |
SANDOZ |
Labeling |
Approval |
09/16/2019 |
PANTOPRAZOLE SODIUM ANDA #090970 |
SUPPL-12 |
PANTOPRAZOLE SODIUM |
MYLAN PHARMS INC |
Labeling |
Approval |
09/16/2019 |
PANTOPRAZOLE SODIUM ANDA #090970 |
SUPPL-14 |
PANTOPRAZOLE SODIUM |
MYLAN PHARMS INC |
Labeling |
Approval |
09/16/2019 |
PANTOPRAZOLE SODIUM ANDA #090970 |
SUPPL-15 |
PANTOPRAZOLE SODIUM |
MYLAN PHARMS INC |
Labeling |
Approval |
09/16/2019 |
PANTOPRAZOLE SODIUM ANDA #090970 |
SUPPL-17 |
PANTOPRAZOLE SODIUM |
MYLAN PHARMS INC |
Labeling |
Approval |
09/16/2019 |
PANTOPRAZOLE SODIUM ANDA #090970 |
SUPPL-18 |
PANTOPRAZOLE SODIUM |
MYLAN PHARMS INC |
Labeling |
Approval |
09/16/2019 |
EZETIMIBE AND SIMVASTATIN ANDA #202968 |
SUPPL-2 |
EZETIMIBE; SIMVASTATIN |
WATSON LABS INC |
Labeling |
Approval |
09/16/2019 |
EZETIMIBE AND SIMVASTATIN ANDA #202968 |
SUPPL-3 |
EZETIMIBE; SIMVASTATIN |
WATSON LABS INC |
Labeling |
Approval |
09/16/2019 |
PANTOPRAZOLE SODIUM ANDA #205119 |
SUPPL-2 |
PANTOPRAZOLE SODIUM |
AMNEAL PHARMS |
Labeling |
Approval |
09/16/2019 |
PANTOPRAZOLE SODIUM ANDA #205119 |
SUPPL-3 |
PANTOPRAZOLE SODIUM |
AMNEAL PHARMS |
Labeling |
Approval |
09/16/2019 |
PANTOPRAZOLE SODIUM ANDA #205119 |
SUPPL-4 |
PANTOPRAZOLE SODIUM |
AMNEAL PHARMS |
Labeling |
Approval |
09/16/2019 |
PANTOPRAZOLE SODIUM ANDA #205119 |
SUPPL-5 |
PANTOPRAZOLE SODIUM |
AMNEAL PHARMS |
Labeling |
Approval |
09/16/2019 |
PANTOPRAZOLE SODIUM ANDA #205119 |
SUPPL-7 |
PANTOPRAZOLE SODIUM |
AMNEAL PHARMS |
Labeling |
Approval |
09/16/2019 |
TRIENTINE HYDROCHLORIDE ANDA #209415 |
ORIG-1 |
TRIENTINE HYDROCHLORIDE |
CHARTWELL RX |
|
Approval |
09/16/2019 |
COLCHICINE ANDA #209470 |
ORIG-1 |
COLCHICINE |
MYLAN |
|
Approval |
09/16/2019 |
ONPATTRO NDA #210922 |
SUPPL-4 |
PATISIRAN SODIUM |
ALNYLAM PHARMS INC |
Labeling |
Approval |
09/16/2019 |
DECITABINE ANDA #210984 |
ORIG-1 |
DECITABINE |
NOVAST LABS |
|
Approval |
09/16/2019 |
ALOSETRON HYDROCHLORIDE ANDA #211621 |
ORIG-1 |
ALOSETRON HYDROCHLORIDE |
EYWA PHARMA |
|
Approval |
09/17/2019 |
THALITONE NDA #019574 |
SUPPL-17 |
CHLORTHALIDONE |
CASPER PHARMA LLC |
Labeling |
Approval |
09/17/2019 |
TACROLIMUS ANDA #065461 |
SUPPL-32 |
TACROLIMUS |
SANDOZ |
Labeling |
Approval |
09/17/2019 |
KEYTRUDA BLA #125514 |
SUPPL-65 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
09/17/2019 |
PANTOPRAZOLE SODIUM ANDA #205675 |
SUPPL-1 |
PANTOPRAZOLE SODIUM |
EUGIA PHARMA |
Labeling |
Approval |
09/17/2019 |
PANTOPRAZOLE SODIUM ANDA #205675 |
SUPPL-5 |
PANTOPRAZOLE SODIUM |
EUGIA PHARMA |
Labeling |
Approval |
09/17/2019 |
PANTOPRAZOLE SODIUM ANDA #205675 |
SUPPL-6 |
PANTOPRAZOLE SODIUM |
EUGIA PHARMA |
Labeling |
Approval |
09/17/2019 |
PANTOPRAZOLE SODIUM ANDA #205675 |
SUPPL-8 |
PANTOPRAZOLE SODIUM |
EUGIA PHARMA |
Labeling |
Approval |
09/17/2019 |
PANTOPRAZOLE SODIUM ANDA #205675 |
SUPPL-11 |
PANTOPRAZOLE SODIUM |
EUGIA PHARMA |
Labeling |
Approval |
09/17/2019 |
OLMESARTAN MEDOXOMIL ANDA #206372 |
ORIG-1 |
OLMESARTAN MEDOXOMIL |
MICRO LABS |
|
Approval |
09/17/2019 |
LENVIMA NDA #206947 |
SUPPL-11 |
LENVATINIB MESYLATE |
EISAI INC |
Efficacy |
Approval |
09/17/2019 |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE ANDA #208847 |
ORIG-1 |
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL |
UMEDICA |
|
Approval |
09/17/2019 |
ERLEADA NDA #210951 |
SUPPL-1 |
APALUTAMIDE |
JANSSEN BIOTECH |
Efficacy |
Approval |
09/18/2019 |
ZANTAC 75 NDA #020520 |
SUPPL-38 |
RANITIDINE HYDROCHLORIDE |
CHATTEM SANOFI |
Labeling |
Approval |
09/18/2019 |
ZANTAC 150 NDA #021698 |
SUPPL-31 |
RANITIDINE HYDROCHLORIDE |
CHATTEM SANOFI |
Labeling |
Approval |
09/18/2019 |
BIAXIN NDA #050662 |
SUPPL-61 |
CLARITHROMYCIN |
ABBVIE |
Labeling |
Approval |
09/18/2019 |
BIAXIN NDA #050698 |
SUPPL-41 |
CLARITHROMYCIN |
ABBVIE |
Labeling |
Approval |
09/18/2019 |
BIAXIN XL NDA #050775 |
SUPPL-29 |
CLARITHROMYCIN |
ABBVIE |
Labeling |
Approval |
09/18/2019 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE ANDA #077179 |
SUPPL-26 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
TEVA PHARMS |
Labeling |
Approval |
09/18/2019 |
INDOMETHACIN ANDA #090403 |
SUPPL-3 |
INDOMETHACIN |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
09/18/2019 |
INDOMETHACIN ANDA #090403 |
SUPPL-5 |
INDOMETHACIN |
ZYDUS LIFESCIENCES |
Labeling |
Approval |
09/18/2019 |
EPINEPHRINE (AUTOINJECTOR) ANDA #090589 |
SUPPL-4 |
EPINEPHRINE |
TEVA PHARMS USA |
Labeling |
Approval |
09/18/2019 |
INDOMETHACIN ANDA #091549 |
SUPPL-3 |
INDOMETHACIN |
AMNEAL PHARMS |
Labeling |
Approval |
09/18/2019 |
INDOMETHACIN ANDA #091549 |
SUPPL-5 |
INDOMETHACIN |
AMNEAL PHARMS |
Labeling |
Approval |
09/18/2019 |
INDOMETHACIN ANDA #091549 |
SUPPL-7 |
INDOMETHACIN |
AMNEAL PHARMS |
Labeling |
Approval |
09/18/2019 |
OPDIVO BLA #125554 |
SUPPL-75 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
09/18/2019 |
INDOMETHACIN ANDA #202711 |
SUPPL-1 |
INDOMETHACIN |
ZYDUS PHARMS |
Labeling |
Approval |
09/18/2019 |
CELECOXIB ANDA #204519 |
SUPPL-5 |
CELECOXIB |
ALEMBIC |
Labeling |
Approval |
09/18/2019 |
CELECOXIB ANDA #204519 |
SUPPL-7 |
CELECOXIB |
ALEMBIC |
Labeling |
Approval |
09/18/2019 |
OZOBAX NDA #208193 |
ORIG-1 |
BACLOFEN |
METACEL PHARMS LLC |
Type 3 - New Dosage Form |
Approval |
09/18/2019 |
OZOBAX DS NDA #208193 |
ORIG-1 |
BACLOFEN |
METACEL PHARMS LLC |
Type 3 - New Dosage Form |
Approval |
09/18/2019 |
DAPTOMYCIN NDA #209949 |
SUPPL-3 |
DAPTOMYCIN |
XELLIA PHARMS APS |
Labeling |
Approval |
09/19/2019 |
SOMAVERT BLA #021106 |
SUPPL-64 |
PEGVISOMANT |
PHARMACIA |
|
Approval |
09/19/2019 |
ZOLPIDEM TARTRATE ANDA #078413 |
SUPPL-12 |
ZOLPIDEM TARTRATE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/19/2019 |
ZOLPIDEM TARTRATE ANDA #078413 |
SUPPL-13 |
ZOLPIDEM TARTRATE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/19/2019 |
ZOLPIDEM TARTRATE ANDA #078413 |
SUPPL-14 |
ZOLPIDEM TARTRATE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/19/2019 |
ZOLPIDEM TARTRATE ANDA #078413 |
SUPPL-15 |
ZOLPIDEM TARTRATE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/19/2019 |
ZOLPIDEM TARTRATE ANDA #078413 |
SUPPL-16 |
ZOLPIDEM TARTRATE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/19/2019 |
ZOLPIDEM TARTRATE ANDA #078413 |
SUPPL-19 |
ZOLPIDEM TARTRATE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/19/2019 |
FENOFIBRIC ACID ANDA #200750 |
SUPPL-9 |
CHOLINE FENOFIBRATE |
CHARTWELL RX |
Labeling |
Approval |
09/19/2019 |
FENOFIBRIC ACID ANDA #200750 |
SUPPL-10 |
CHOLINE FENOFIBRATE |
CHARTWELL RX |
Labeling |
Approval |
09/19/2019 |
FENOFIBRIC ACID ANDA #200750 |
SUPPL-11 |
CHOLINE FENOFIBRATE |
CHARTWELL RX |
Labeling |
Approval |
09/19/2019 |
FENOFIBRIC ACID ANDA #200750 |
SUPPL-14 |
CHOLINE FENOFIBRATE |
CHARTWELL RX |
Labeling |
Approval |
09/19/2019 |
FENOFIBRIC ACID ANDA #200913 |
SUPPL-5 |
CHOLINE FENOFIBRATE |
MYLAN PHARMS INC |
Labeling |
Approval |
09/19/2019 |
FENOFIBRIC ACID ANDA #200913 |
SUPPL-6 |
CHOLINE FENOFIBRATE |
MYLAN PHARMS INC |
Labeling |
Approval |
09/19/2019 |
HEPARIN SODIUM NDA #201370 |
SUPPL-13 |
HEPARIN SODIUM |
PFIZER |
Labeling |
Approval |
09/19/2019 |
HEPARIN SODIUM NDA #201370 |
SUPPL-14 |
HEPARIN SODIUM |
PFIZER |
Labeling |
Approval |
09/19/2019 |
HEPARIN SODIUM PRESERVATIVE FREE NDA #201370 |
SUPPL-13 |
HEPARIN SODIUM |
PFIZER |
Labeling |
Approval |
09/19/2019 |
HEPARIN SODIUM PRESERVATIVE FREE NDA #201370 |
SUPPL-14 |
HEPARIN SODIUM |
PFIZER |
Labeling |
Approval |
09/19/2019 |
SOVALDI NDA #204671 |
SUPPL-16 |
SOFOSBUVIR |
GILEAD SCIENCES INC |
Labeling |
Approval |
09/19/2019 |
HARVONI NDA #205834 |
SUPPL-31 |
LEDIPASVIR; SOFOSBUVIR |
GILEAD SCIENCES INC |
Labeling |
Approval |
09/19/2019 |
FENOFIBRATE (MICRONIZED) ANDA #207564 |
SUPPL-1 |
FENOFIBRATE |
NOVAST LABS |
Labeling |
Approval |
09/19/2019 |
EPCLUSA NDA #208341 |
SUPPL-13 |
SOFOSBUVIR; VELPATASVIR |
GILEAD SCIENCES INC |
Labeling |
Approval |
09/19/2019 |
FENOFIBRIC ACID ANDA #208705 |
SUPPL-7 |
CHOLINE FENOFIBRATE |
ALEMBIC |
Labeling |
Approval |
09/19/2019 |
FENOFIBRIC ACID ANDA #208705 |
SUPPL-9 |
CHOLINE FENOFIBRATE |
ALEMBIC |
Labeling |
Approval |
09/19/2019 |
FENOFIBRIC ACID ANDA #208705 |
SUPPL-11 |
CHOLINE FENOFIBRATE |
ALEMBIC |
Labeling |
Approval |
09/19/2019 |
FENOFIBRATE ANDA #208709 |
SUPPL-2 |
FENOFIBRATE |
CIPLA |
Labeling |
Approval |
09/19/2019 |
FENOFIBRATE ANDA #208709 |
SUPPL-3 |
FENOFIBRATE |
CIPLA |
Labeling |
Approval |
09/19/2019 |
FENOFIBRATE ANDA #208709 |
SUPPL-5 |
FENOFIBRATE |
CIPLA |
Labeling |
Approval |
09/19/2019 |
ATOVAQUONE ANDA #209105 |
SUPPL-3 |
ATOVAQUONE |
LUPIN LTD |
Labeling |
Approval |
09/19/2019 |
ATOVAQUONE ANDA #209105 |
SUPPL-5 |
ATOVAQUONE |
LUPIN LTD |
Labeling |
Approval |
09/19/2019 |
PIFELTRO NDA #210806 |
SUPPL-2 |
DORAVIRINE |
MSD MERCK CO |
Efficacy |
Approval |
09/19/2019 |
DELSTRIGO NDA #210807 |
SUPPL-2 |
DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
MSD MERCK CO |
Efficacy |
Approval |
09/19/2019 |
POTASSIUM PHOSPHATES NDA #212121 |
ORIG-1 |
POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC |
CMP DEV LLC |
Type 5 - New Formulation or New Manufacturer |
Approval |
09/19/2019 |
HARVONI NDA #212477 |
SUPPL-1 |
LEDIPASVIR; SOFOSBUVIR |
GILEAD SCIENCES INC |
Labeling |
Approval |
09/19/2019 |
SOVALDI NDA #212480 |
SUPPL-1 |
SOFOSBUVIR |
GILEAD SCIENCES INC |
Labeling |
Approval |
09/20/2019 |
INVANZ NDA #021337 |
SUPPL-48 |
ERTAPENEM SODIUM |
MSD SUB MERCK |
Labeling |
Approval |
09/20/2019 |
JANTOVEN ANDA #040416 |
SUPPL-31 |
WARFARIN SODIUM |
UPSHER SMITH LABS |
Labeling |
Approval |
09/20/2019 |
JANTOVEN ANDA #040416 |
SUPPL-33 |
WARFARIN SODIUM |
UPSHER SMITH LABS |
Labeling |
Approval |
09/20/2019 |
TEMAZEPAM ANDA #071456 |
SUPPL-12 |
TEMAZEPAM |
NOVEL LABS INC |
Labeling |
Approval |
09/20/2019 |
CLOPIDOGREL BISULFATE ANDA #090540 |
SUPPL-19 |
CLOPIDOGREL BISULFATE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/20/2019 |
PREGABALIN ANDA #091228 |
ORIG-1 |
PREGABALIN |
MYLAN |
|
Approval |
09/20/2019 |
SOLIFENACIN SUCCINATE ANDA #091464 |
SUPPL-1 |
SOLIFENACIN SUCCINATE |
TEVA PHARMS USA |
Labeling |
Approval |
09/20/2019 |
YERVOY BLA #125377 |
SUPPL-104 |
IPILIMUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
09/20/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #202415 |
SUPPL-4 |
DONEPEZIL HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
09/20/2019 |
ZOLMITRIPTAN ANDA #202855 |
ORIG-1 |
ZOLMITRIPTAN |
RISING |
|
Approval |
09/20/2019 |
CLOPIDOGREL BISULFATE ANDA #202925 |
SUPPL-11 |
CLOPIDOGREL BISULFATE |
ACCORD HLTHCARE |
Labeling |
Approval |
09/20/2019 |
CLOPIDOGREL BISULFATE ANDA #202928 |
SUPPL-20 |
CLOPIDOGREL BISULFATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/20/2019 |
ATOVAQUONE ANDA #202960 |
SUPPL-7 |
ATOVAQUONE |
AMNEAL PHARMS |
Labeling |
Approval |
09/20/2019 |
ATOVAQUONE ANDA #202960 |
SUPPL-9 |
ATOVAQUONE |
AMNEAL PHARMS |
Labeling |
Approval |
09/20/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #203162 |
SUPPL-1 |
DONEPEZIL HYDROCHLORIDE |
ZYDUS PHARMS |
Labeling |
Approval |
09/20/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #203713 |
SUPPL-3 |
DONEPEZIL HYDROCHLORIDE |
DEXCEL |
Labeling |
Approval |
09/20/2019 |
VALSARTAN ANDA #204011 |
SUPPL-1 |
VALSARTAN |
AMNEAL PHARMS |
Labeling |
Approval |
09/20/2019 |
VALSARTAN ANDA #204011 |
SUPPL-2 |
VALSARTAN |
AMNEAL PHARMS |
Labeling |
Approval |
09/20/2019 |
ATOVAQUONE ANDA #209750 |
SUPPL-3 |
ATOVAQUONE |
APOTEX |
Labeling |
Approval |
09/20/2019 |
ATOVAQUONE ANDA #209750 |
SUPPL-4 |
ATOVAQUONE |
APOTEX |
Labeling |
Approval |
09/20/2019 |
CEQUA NDA #210913 |
SUPPL-2 |
CYCLOSPORINE |
SUN PHARM |
Labeling |
Approval |
09/20/2019 |
RYBELSUS NDA #213051 |
ORIG-1 |
SEMAGLUTIDE |
NOVO |
Type 3 - New Dosage Form |
Approval |
09/23/2019 |
DELSYM NDA #018658 |
SUPPL-31 |
DEXTROMETHORPHAN POLISTIREX |
RB HLTH |
Manufacturing (CMC) |
Approval |
09/23/2019 |
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE ANDA #040163 |
SUPPL-3 |
MEPERIDINE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
09/23/2019 |
VINCRISTINE SULFATE PFS ANDA #071484 |
SUPPL-44 |
VINCRISTINE SULFATE |
HOSPIRA |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #076520 |
SUPPL-12 |
FENOFIBRATE |
MYLAN |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #076520 |
SUPPL-15 |
FENOFIBRATE |
MYLAN |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #076520 |
SUPPL-16 |
FENOFIBRATE |
MYLAN |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #076520 |
SUPPL-17 |
FENOFIBRATE |
MYLAN |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #076520 |
SUPPL-18 |
FENOFIBRATE |
MYLAN |
Labeling |
Approval |
09/23/2019 |
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE ANDA #081002 |
SUPPL-9 |
MEPERIDINE HYDROCHLORIDE |
WEST-WARD PHARMS INT |
Labeling |
Approval |
09/23/2019 |
BUPRENORPHINE HYDROCHLORIDE ANDA #090819 |
SUPPL-14 |
BUPRENORPHINE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #090856 |
SUPPL-10 |
FENOFIBRATE |
LUPIN LTD |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #090856 |
SUPPL-12 |
FENOFIBRATE |
LUPIN LTD |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #090856 |
SUPPL-13 |
FENOFIBRATE |
LUPIN LTD |
Labeling |
Approval |
09/23/2019 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #091422 |
SUPPL-25 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
ACTAVIS ELIZABETH |
Labeling |
Approval |
09/23/2019 |
BIVALIRUDIN ANDA #091602 |
SUPPL-1 |
BIVALIRUDIN |
MEITHEAL |
Labeling |
Approval |
09/23/2019 |
BIVALIRUDIN ANDA #091602 |
SUPPL-5 |
BIVALIRUDIN |
MEITHEAL |
Labeling |
Approval |
09/23/2019 |
FENOFIBRIC ACID ANDA #200264 |
SUPPL-2 |
CHOLINE FENOFIBRATE |
IMPAX LABS INC |
Labeling |
Approval |
09/23/2019 |
FENOFIBRIC ACID ANDA #200264 |
SUPPL-3 |
CHOLINE FENOFIBRATE |
IMPAX LABS INC |
Labeling |
Approval |
09/23/2019 |
BIVALIRUDIN ANDA #202471 |
SUPPL-3 |
BIVALIRUDIN |
MYLAN INSTITUTIONAL |
Labeling |
Approval |
09/23/2019 |
METAXALONE ANDA #203399 |
SUPPL-6 |
METAXALONE |
AMNEAL PHARMS |
Labeling |
Approval |
09/23/2019 |
TAMSULOSIN HYDROCHLORIDE ANDA #204645 |
SUPPL-9 |
TAMSULOSIN HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
09/23/2019 |
PALIPERIDONE ANDA #204707 |
ORIG-1 |
PALIPERIDONE |
AMNEAL PHARMS |
|
Approval |
09/23/2019 |
METAXALONE ANDA #204770 |
SUPPL-4 |
METAXALONE |
LANNETT CO INC |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #205118 |
SUPPL-3 |
FENOFIBRATE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #205118 |
SUPPL-5 |
FENOFIBRATE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #205118 |
SUPPL-8 |
FENOFIBRATE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/23/2019 |
BIVALIRUDIN ANDA #205962 |
SUPPL-1 |
BIVALIRUDIN |
EUGIA PHARMA |
Labeling |
Approval |
09/23/2019 |
VALGANCICLOVIR HYDROCHLORIDE ANDA #206876 |
SUPPL-1 |
VALGANCICLOVIR HYDROCHLORIDE |
DR REDDYS |
Labeling |
Approval |
09/23/2019 |
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE ANDA #207000 |
SUPPL-2 |
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
SPECGX LLC |
Labeling |
Approval |
09/23/2019 |
OXYBUTYNIN CHLORIDE ANDA #207138 |
SUPPL-5 |
OXYBUTYNIN CHLORIDE |
ACCORD HLTHCARE |
Labeling |
Approval |
09/23/2019 |
TAMSULOSIN HYDROCHLORIDE ANDA #207405 |
SUPPL-3 |
TAMSULOSIN HYDROCHLORIDE |
ALKEM LABS LTD |
Labeling |
Approval |
09/23/2019 |
OXYCODONE AND ACETAMINOPHEN ANDA #207510 |
SUPPL-2 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
WES PHARMA INC |
Labeling |
Approval |
09/23/2019 |
NARCAN NDA #208411 |
SUPPL-2 |
NALOXONE HYDROCHLORIDE |
EMERGENT |
Manufacturing (CMC) |
Approval |
09/23/2019 |
TESTOSTERONE ANDA #209390 |
ORIG-1 |
TESTOSTERONE |
TWI PHARMS |
|
Approval |
09/23/2019 |
FENOFIBRATE ANDA #209951 |
SUPPL-1 |
FENOFIBRATE |
AMNEAL |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #209951 |
SUPPL-2 |
FENOFIBRATE |
AMNEAL |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #209951 |
SUPPL-3 |
FENOFIBRATE |
AMNEAL |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #210606 |
SUPPL-1 |
FENOFIBRATE |
GRAVITI PHARMS |
Labeling |
Approval |
09/23/2019 |
FENOFIBRATE ANDA #210606 |
SUPPL-2 |
FENOFIBRATE |
GRAVITI PHARMS |
Labeling |
Approval |
09/23/2019 |
SOLIFENACIN SUCCINATE ANDA #210688 |
SUPPL-1 |
SOLIFENACIN SUCCINATE |
MSN |
Labeling |
Approval |
09/23/2019 |
LEVOCETIRIZINE HYDROCHLORIDE ANDA #210914 |
SUPPL-1 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
HETERO LABS LTD III |
Labeling |
Approval |
09/24/2019 |
MANNITOL 10% IN PLASTIC CONTAINER NDA #020006 |
SUPPL-28 |
MANNITOL |
B BRAUN |
Efficacy |
Approval |
09/24/2019 |
MANNITOL 15% IN PLASTIC CONTAINER NDA #020006 |
SUPPL-28 |
MANNITOL |
B BRAUN |
Efficacy |
Approval |
09/24/2019 |
MANNITOL 20% IN PLASTIC CONTAINER NDA #020006 |
SUPPL-28 |
MANNITOL |
B BRAUN |
Efficacy |
Approval |
09/24/2019 |
MANNITOL 5% IN PLASTIC CONTAINER NDA #020006 |
SUPPL-28 |
MANNITOL |
B BRAUN |
Efficacy |
Approval |
09/24/2019 |
SOMAVERT BLA #021106 |
SUPPL-45 |
PEGVISOMANT |
PHARMACIA |
|
Approval |
09/24/2019 |
ZEGERID NDA #021636 |
SUPPL-20 |
OMEPRAZOLE; SODIUM BICARBONATE |
SALIX |
Labeling |
Approval |
09/24/2019 |
ZEGERID NDA #021849 |
SUPPL-15 |
OMEPRAZOLE; SODIUM BICARBONATE |
SALIX |
Labeling |
Approval |
09/24/2019 |
VERAPAMIL HYDROCHLORIDE ANDA #074587 |
SUPPL-39 |
VERAPAMIL HYDROCHLORIDE |
RISING |
Labeling |
Approval |
09/24/2019 |
VERAPAMIL HYDROCHLORIDE ANDA #074587 |
SUPPL-40 |
VERAPAMIL HYDROCHLORIDE |
RISING |
Labeling |
Approval |
09/24/2019 |
VERAPAMIL HYDROCHLORIDE ANDA #090529 |
SUPPL-11 |
VERAPAMIL HYDROCHLORIDE |
SUN PHARM INDS INC |
Labeling |
Approval |
09/24/2019 |
VERAPAMIL HYDROCHLORIDE ANDA #090529 |
SUPPL-13 |
VERAPAMIL HYDROCHLORIDE |
SUN PHARM INDS INC |
Labeling |
Approval |
09/24/2019 |
SIMPONI BLA #125289 |
SUPPL-146 |
GOLIMUMAB |
CENTOCOR ORTHO BIOTECH INC |
|
Approval |
09/24/2019 |
SIMPONI ARIA BLA #125433 |
SUPPL-28 |
GOLIMUMAB |
JANSSEN BIOTECH |
|
Approval |
09/24/2019 |
LAMIVUDINE ANDA #202032 |
SUPPL-6 |
LAMIVUDINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/24/2019 |
LAMIVUDINE ANDA #202032 |
SUPPL-7 |
LAMIVUDINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/24/2019 |
LAMIVUDINE ANDA #202032 |
SUPPL-8 |
LAMIVUDINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/24/2019 |
LAMIVUDINE ANDA #202032 |
SUPPL-10 |
LAMIVUDINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/24/2019 |
LAMIVUDINE ANDA #202032 |
SUPPL-11 |
LAMIVUDINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/24/2019 |
LAMIVUDINE ANDA #202032 |
SUPPL-13 |
LAMIVUDINE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
09/24/2019 |
DONEPEZIL HYDROCHLORIDE ANDA #203104 |
SUPPL-5 |
DONEPEZIL HYDROCHLORIDE |
TWI PHARMS |
Labeling |
Approval |
09/24/2019 |
CLOBETASOL PROPIONATE ANDA #205249 |
ORIG-1 |
CLOBETASOL PROPIONATE |
ZYDUS LIFESCIENCES |
|
Approval |
09/24/2019 |
LAMIVUDINE AND ZIDOVUDINE ANDA #206375 |
SUPPL-1 |
LAMIVUDINE; ZIDOVUDINE |
ANDA REPOSITORY |
Labeling |
Approval |
09/24/2019 |
LAMIVUDINE AND ZIDOVUDINE ANDA #206375 |
SUPPL-2 |
LAMIVUDINE; ZIDOVUDINE |
ANDA REPOSITORY |
Labeling |
Approval |
09/24/2019 |
TREPROSTINIL ANDA #209382 |
ORIG-1 |
TREPROSTINIL |
ENDO OPERATIONS |
|
Approval |
09/24/2019 |
TALZENNA NDA #211651 |
SUPPL-2 |
TALAZOPARIB TOSYLATE |
PFIZER |
Efficacy |
Approval |
09/25/2019 |
LAMICTAL NDA #020241 |
SUPPL-60 |
LAMOTRIGINE |
GLAXOSMITHKLINE LLC |
Labeling |
Approval |
09/25/2019 |
FRAGMIN NDA #020287 |
SUPPL-60 |
DALTEPARIN SODIUM |
PFIZER |
Labeling |
Approval |
09/25/2019 |
LAMICTAL CD NDA #020764 |
SUPPL-53 |
LAMOTRIGINE |
GLAXOSMITHKLINE LLC |
Labeling |
Approval |
09/25/2019 |
EMEND NDA #021549 |
SUPPL-31 |
APREPITANT |
MERCK |
Labeling |
Approval |
09/25/2019 |
TASIGNA NDA #022068 |
SUPPL-31 |
NILOTINIB HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
09/25/2019 |
LAMICTAL XR NDA #022115 |
SUPPL-26 |
LAMOTRIGINE |
GLAXOSMITHKLINE LLC |
Labeling |
Approval |
09/25/2019 |
LAMICTAL ODT NDA #022251 |
SUPPL-24 |
LAMOTRIGINE |
GLAXOSMITHKLINE LLC |
Labeling |
Approval |
09/25/2019 |
ACARBOSE ANDA #077532 |
SUPPL-8 |
ACARBOSE |
WATSON LABS |
Labeling |
Approval |
09/25/2019 |
DYSPORT BLA #125274 |
SUPPL-115 |
abobotulinumtoxinA |
IPSEN BIOPHARM LTD |
|
Approval |
09/25/2019 |
VERAPAMIL HYDROCHLORIDE ANDA #206173 |
SUPPL-1 |
VERAPAMIL HYDROCHLORIDE |
CADILA PHARMS LTD |
Labeling |
Approval |
09/25/2019 |
EMEND NDA #207865 |
SUPPL-4 |
APREPITANT |
MSD MERCK CO |
Labeling |
Approval |
09/25/2019 |
TRIENTINE HYDROCHLORIDE ANDA #210096 |
ORIG-1 |
TRIENTINE HYDROCHLORIDE |
ENDO OPERATIONS |
|
Approval |
09/25/2019 |
ENTECAVIR ANDA #212126 |
ORIG-1 |
ENTECAVIR |
BRIGHTGENE |
|
Approval |
09/26/2019 |
LISINOPRIL ANDA #076164 |
SUPPL-19 |
LISINOPRIL |
PRINSTON INC |
Labeling |
Approval |
09/26/2019 |
LAMIVUDINE ANDA #077464 |
SUPPL-13 |
LAMIVUDINE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/26/2019 |
LAMIVUDINE ANDA #077464 |
SUPPL-14 |
LAMIVUDINE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/26/2019 |
LAMIVUDINE ANDA #077464 |
SUPPL-16 |
LAMIVUDINE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/26/2019 |
VERAPAMIL HYDROCHLORIDE ANDA #078306 |
SUPPL-10 |
VERAPAMIL HYDROCHLORIDE |
RISING |
Labeling |
Approval |
09/26/2019 |
VERAPAMIL HYDROCHLORIDE ANDA #078906 |
SUPPL-7 |
VERAPAMIL HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
09/26/2019 |
VERAPAMIL HYDROCHLORIDE ANDA #078906 |
SUPPL-9 |
VERAPAMIL HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
09/26/2019 |
LAMIVUDINE ANDA #090457 |
SUPPL-10 |
LAMIVUDINE |
STRIDES PHARMA |
Labeling |
Approval |
09/26/2019 |
LAMIVUDINE ANDA #090457 |
SUPPL-12 |
LAMIVUDINE |
STRIDES PHARMA |
Labeling |
Approval |
09/26/2019 |
VERAPAMIL HYDROCHLORIDE ANDA #090700 |
SUPPL-4 |
VERAPAMIL HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
09/26/2019 |
VERAPAMIL HYDROCHLORIDE ANDA #090700 |
SUPPL-6 |
VERAPAMIL HYDROCHLORIDE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
09/26/2019 |
WARFARIN SODIUM ANDA #090935 |
SUPPL-3 |
WARFARIN SODIUM |
INVAGEN PHARMS |
Labeling |
Approval |
09/26/2019 |
WARFARIN SODIUM ANDA #090935 |
SUPPL-5 |
WARFARIN SODIUM |
INVAGEN PHARMS |
Labeling |
Approval |
09/26/2019 |
WARFARIN SODIUM ANDA #090935 |
SUPPL-9 |
WARFARIN SODIUM |
INVAGEN PHARMS |
Labeling |
Approval |
09/26/2019 |
TOPOTECAN HYDROCHLORIDE ANDA #091199 |
SUPPL-3 |
TOPOTECAN HYDROCHLORIDE |
TEYRO LABS |
Labeling |
Approval |
09/26/2019 |
LAMIVUDINE ANDA #203277 |
SUPPL-1 |
LAMIVUDINE |
HETERO LABS LTD V |
Labeling |
Approval |
09/26/2019 |
LAMIVUDINE ANDA #203277 |
SUPPL-2 |
LAMIVUDINE |
HETERO LABS LTD V |
Labeling |
Approval |
09/26/2019 |
LAMIVUDINE ANDA #203277 |
SUPPL-3 |
LAMIVUDINE |
HETERO LABS LTD V |
Labeling |
Approval |
09/26/2019 |
LAMIVUDINE ANDA #203277 |
SUPPL-4 |
LAMIVUDINE |
HETERO LABS LTD V |
Labeling |
Approval |
09/26/2019 |
LAMIVUDINE ANDA #203277 |
SUPPL-5 |
LAMIVUDINE |
HETERO LABS LTD V |
Labeling |
Approval |
09/26/2019 |
CYCLOPHOSPHAMIDE NDA #203856 |
SUPPL-3 |
CYCLOPHOSPHAMIDE |
HIKMA |
Labeling |
Approval |
09/26/2019 |
OMEPRAZOLE ANDA #204012 |
ORIG-1 |
OMEPRAZOLE |
HETERO LABS LTD III |
|
Approval |
09/26/2019 |
TREPROSTINIL ANDA #206648 |
ORIG-1 |
TREPROSTINIL |
TEVA PHARMS USA |
|
Approval |
09/26/2019 |
EZETIMIBE AND SIMVASTATIN ANDA #208831 |
SUPPL-2 |
EZETIMIBE; SIMVASTATIN |
AMNEAL PHARMS CO |
Labeling |
Approval |
09/26/2019 |
EZETIMIBE AND SIMVASTATIN ANDA #209222 |
SUPPL-5 |
EZETIMIBE; SIMVASTATIN |
ALKEM LABS LTD |
Labeling |
Approval |
09/26/2019 |
OLOPATADINE HYDROCHLORIDE ANDA #209282 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
FDC LTD |
|
Approval |
09/26/2019 |
MAVYRET NDA #209394 |
SUPPL-7 |
GLECAPREVIR; PIBRENTASVIR |
ABBVIE |
Efficacy |
Approval |
09/26/2019 |
MAVYRET NDA #209394 |
SUPPL-8 |
GLECAPREVIR; PIBRENTASVIR |
ABBVIE |
Efficacy |
Approval |
09/26/2019 |
DOXERCALCIFEROL ANDA #210452 |
ORIG-1 |
DOXERCALCIFEROL |
GLAND PHARMA LTD |
|
Approval |
09/26/2019 |
COPIKTRA NDA #211155 |
SUPPL-1 |
DUVELISIB |
SECURA |
Labeling |
Approval |
09/26/2019 |
SOLIFENACIN SUCCINATE ANDA #212214 |
ORIG-1 |
SOLIFENACIN SUCCINATE |
STRIDES PHARMA |
|
Approval |
09/26/2019 |
DARZALEX BLA #761036 |
SUPPL-24 |
DARATUMUMAB |
JANSSEN BIOTECH |
|
Approval |
09/27/2019 |
WARFARIN SODIUM ANDA #040301 |
SUPPL-34 |
WARFARIN SODIUM |
TARO |
Labeling |
Approval |
09/27/2019 |
WARFARIN SODIUM ANDA #040301 |
SUPPL-36 |
WARFARIN SODIUM |
TARO |
Labeling |
Approval |
09/27/2019 |
WARFARIN SODIUM ANDA #040301 |
SUPPL-38 |
WARFARIN SODIUM |
TARO |
Labeling |
Approval |
09/27/2019 |
RIFAMATE ANDA #061884 |
SUPPL-18 |
ISONIAZID; RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
09/27/2019 |
RIFAMATE ANDA #061884 |
SUPPL-19 |
ISONIAZID; RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
09/27/2019 |
RIFAMATE ANDA #061884 |
SUPPL-20 |
ISONIAZID; RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
09/27/2019 |
RIFAMATE ANDA #061884 |
SUPPL-22 |
ISONIAZID; RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
09/27/2019 |
RIFAMATE ANDA #061884 |
SUPPL-25 |
ISONIAZID; RIFAMPIN |
SANOFI AVENTIS US |
Labeling |
Approval |
09/27/2019 |
VERAPAMIL HYDROCHLORIDE ANDA #071483 |
SUPPL-26 |
VERAPAMIL HYDROCHLORIDE |
RISING |
Labeling |
Approval |
09/27/2019 |
VERAPAMIL HYDROCHLORIDE ANDA #071483 |
SUPPL-27 |
VERAPAMIL HYDROCHLORIDE |
RISING |
Labeling |
Approval |
09/27/2019 |
DESIPRAMINE HYDROCHLORIDE ANDA #072103 |
SUPPL-30 |
DESIPRAMINE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
09/27/2019 |
VERAPAMIL HYDROCHLORIDE ANDA #075138 |
SUPPL-17 |
VERAPAMIL HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
09/27/2019 |
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE ANDA #081309 |
SUPPL-9 |
MEPERIDINE HYDROCHLORIDE |
INTL MEDICATION |
Labeling |
Approval |
09/27/2019 |
RITUXAN BLA #103705 |
SUPPL-5457 |
RITUXIMAB |
GENENTECH |
|
Approval |
09/27/2019 |
OXYCODONE AND ACETAMINOPHEN ANDA #203864 |
SUPPL-3 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
09/27/2019 |
INVOKANA NDA #204042 |
SUPPL-32 |
CANAGLIFLOZIN |
JANSSEN PHARMS |
Efficacy |
Approval |
09/27/2019 |
METHYLPHENIDATE HYDROCHLORIDE ANDA #204772 |
SUPPL-7 |
METHYLPHENIDATE HYDROCHLORIDE |
ALVOGEN |
Manufacturing (CMC) |
Approval |
09/27/2019 |
DALFAMPRIDINE ANDA #206811 |
SUPPL-2 |
DALFAMPRIDINE |
AUROBINDO PHARMA |
Labeling |
Approval |
09/27/2019 |
NUPLAZID NDA #207318 |
SUPPL-9 |
PIMAVANSERIN TARTRATE |
ACADIA PHARMS INC |
Labeling |
Approval |
09/27/2019 |
METAXALONE ANDA #207466 |
SUPPL-5 |
METAXALONE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
09/27/2019 |
MOXIFLOXACIN HYDROCHLORIDE ANDA #208682 |
SUPPL-1 |
MOXIFLOXACIN HYDROCHLORIDE |
MSN |
Manufacturing (CMC) |
Approval |
09/27/2019 |
VOSEVI NDA #209195 |
SUPPL-4 |
SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR |
GILEAD SCIENCES INC |
Labeling |
Approval |
09/27/2019 |
DAPSONE ANDA #209506 |
SUPPL-1 |
DAPSONE |
TARO |
Labeling |
Approval |
09/27/2019 |
IDHIFA NDA #209606 |
SUPPL-2 |
ENASIDENIB MESYLATE |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
09/27/2019 |
NUPLAZID NDA #210793 |
SUPPL-3 |
PIMAVANSERIN TARTRATE |
ACADIA PHARMS INC |
Labeling |
Approval |
09/27/2019 |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE ANDA #211491 |
ORIG-1 |
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE |
SUN PHARM INDS LTD |
|
Tentative Approval |
09/27/2019 |
EMPAGLIFLOZIN ANDA #212358 |
ORIG-1 |
EMPAGLIFLOZIN |
MSN LABS PVT LTD |
|
Tentative Approval |
09/27/2019 |
ABIRATERONE ACETATE ANDA #212462 |
ORIG-1 |
ABIRATERONE ACETATE |
QILU |
|
Approval |
09/27/2019 |
CRYSVITA BLA #761068 |
SUPPL-3 |
BUROSUMAB-TWZA |
KYOWA KIRIN |
|
Approval |
09/27/2019 |
CRYSVITA BLA #761068 |
SUPPL-4 |
BUROSUMAB-TWZA |
KYOWA KIRIN |
|
Approval |
09/28/2019 |
AUVI-Q NDA #201739 |
SUPPL-15 |
EPINEPHRINE |
KALEO INC |
Labeling |
Approval |
09/30/2019 |
NEXIUM IV NDA #021689 |
SUPPL-34 |
ESOMEPRAZOLE SODIUM |
ASTRAZENECA |
Labeling |
Approval |
09/30/2019 |
FIBRICOR NDA #022418 |
SUPPL-16 |
FENOFIBRIC ACID |
ATHENA |
Labeling |
Approval |
09/30/2019 |
TEMAZEPAM ANDA #071620 |
SUPPL-37 |
TEMAZEPAM |
ACTAVIS ELIZABETH |
Labeling |
Approval |
09/30/2019 |
TEMAZEPAM ANDA #071620 |
SUPPL-38 |
TEMAZEPAM |
ACTAVIS ELIZABETH |
Labeling |
Approval |
09/30/2019 |
LAMIVUDINE ANDA #077221 |
SUPPL-1 |
LAMIVUDINE |
CIPLA |
Labeling |
Approval |
09/30/2019 |
LAMIVUDINE ANDA #077221 |
SUPPL-2 |
LAMIVUDINE |
CIPLA |
Labeling |
Approval |
09/30/2019 |
LAMIVUDINE ANDA #077221 |
SUPPL-3 |
LAMIVUDINE |
CIPLA |
Labeling |
Approval |
09/30/2019 |
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE ANDA #201615 |
SUPPL-9 |
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE |
CHARTWELL RX |
Labeling |
Approval |
09/30/2019 |
DESIPRAMINE HYDROCHLORIDE ANDA #204963 |
SUPPL-2 |
DESIPRAMINE HYDROCHLORIDE |
NOVAST LABS |
Labeling |
Approval |
09/30/2019 |
VILAZODONE HYDROCHLORIDE ANDA #208212 |
ORIG-1 |
VILAZODONE HYDROCHLORIDE |
TEVA PHARMS USA |
|
Approval |
09/30/2019 |
DESFLURANE ANDA #208234 |
SUPPL-4 |
DESFLURANE |
SHANGHAI HENGRUI |
Labeling |
Approval |
09/30/2019 |
PREGABALIN ANDA #210891 |
ORIG-1 |
PREGABALIN |
YILING |
|
Approval |
09/30/2019 |
ZULRESSO NDA #211371 |
SUPPL-3 |
BREXANOLONE |
SAGE THERAP |
REMS |
Approval |
09/30/2019 |
EXTENDED PHENYTOIN SODIUM ANDA #211633 |
ORIG-1 |
PHENYTOIN SODIUM |
LUPIN LTD |
|
Approval |
09/30/2019 |
POTASSIUM CHLORIDE ANDA #212561 |
ORIG-1 |
POTASSIUM CHLORIDE |
YICHANG HUMANWELL |
|
Approval |
09/30/2019 |
GLYCOPYRROLATE ANDA #212612 |
ORIG-1 |
GLYCOPYRROLATE |
GLAND PHARMA LTD |
|
Approval |