03/01/2019 |
ROBAXIN NDA #011011 |
SUPPL-79 |
METHOCARBAMOL |
ENDO OPERATIONS |
Labeling |
Approval |
03/01/2019 |
ROBAXIN-750 NDA #011011 |
SUPPL-79 |
METHOCARBAMOL |
ENDO OPERATIONS |
Labeling |
Approval |
03/01/2019 |
TRANSDERM SCOP NDA #017874 |
SUPPL-43 |
SCOPOLAMINE |
BAXTER HLTHCARE CORP |
Efficacy |
Approval |
03/01/2019 |
TRANSDERM SCOP NDA #017874 |
SUPPL-44 |
SCOPOLAMINE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
03/01/2019 |
ZOCOR NDA #019766 |
SUPPL-92 |
SIMVASTATIN |
ORGANON |
Labeling |
Approval |
03/01/2019 |
SUPRANE NDA #020118 |
SUPPL-22 |
DESFLURANE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
03/01/2019 |
SUPRANE NDA #020118 |
SUPPL-23 |
DESFLURANE |
BAXTER HLTHCARE |
Labeling |
Approval |
03/01/2019 |
CLARINEX NDA #021165 |
SUPPL-20 |
DESLORATADINE |
ORGANON |
Labeling |
Approval |
03/01/2019 |
FLECTOR NDA #021234 |
SUPPL-16 |
DICLOFENAC EPOLAMINE |
IBSA |
Efficacy |
Approval |
03/01/2019 |
FLECTOR NDA #021234 |
SUPPL-17 |
DICLOFENAC EPOLAMINE |
IBSA |
Labeling |
Approval |
03/01/2019 |
CLARINEX NDA #021300 |
SUPPL-17 |
DESLORATADINE |
MERCK SHARP DOHME |
Labeling |
Approval |
03/01/2019 |
CLARINEX NDA #021312 |
SUPPL-18 |
DESLORATADINE |
ORGANON |
Labeling |
Approval |
03/01/2019 |
CLARINEX NDA #021563 |
SUPPL-6 |
DESLORATADINE |
SCHERING |
Labeling |
Approval |
03/01/2019 |
FENOFIBRATE ANDA #076509 |
SUPPL-31 |
FENOFIBRATE |
IMPAX LABS |
Labeling |
Approval |
03/01/2019 |
METFORMIN HYDROCHLORIDE ANDA #076706 |
SUPPL-14 |
METFORMIN HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
03/01/2019 |
METFORMIN HYDROCHLORIDE ANDA #076706 |
SUPPL-16 |
METFORMIN HYDROCHLORIDE |
APOTEX |
Labeling |
Approval |
03/01/2019 |
METFORMIN HYDROCHLORIDE ANDA #076864 |
SUPPL-15 |
METFORMIN HYDROCHLORIDE |
TEVA |
Labeling |
Approval |
03/01/2019 |
METFORMIN HYDROCHLORIDE ANDA #076864 |
SUPPL-16 |
METFORMIN HYDROCHLORIDE |
TEVA |
Labeling |
Approval |
03/01/2019 |
METFORMIN HYDROCHLORIDE ANDA #077336 |
SUPPL-12 |
METFORMIN HYDROCHLORIDE |
SUN PHARM INDS (IN) |
Labeling |
Approval |
03/01/2019 |
METFORMIN HYDROCHLORIDE ANDA #077336 |
SUPPL-15 |
METFORMIN HYDROCHLORIDE |
SUN PHARM INDS (IN) |
Labeling |
Approval |
03/01/2019 |
BUSPIRONE HYDROCHLORIDE ANDA #204582 |
SUPPL-1 |
BUSPIRONE HYDROCHLORIDE |
HERITAGE PHARMA |
Labeling |
Approval |
03/01/2019 |
BUSPIRONE HYDROCHLORIDE ANDA #204582 |
SUPPL-2 |
BUSPIRONE HYDROCHLORIDE |
HERITAGE PHARMA |
Manufacturing (CMC) |
Approval |
03/01/2019 |
PERPHENAZINE ANDA #205056 |
ORIG-1 |
PERPHENAZINE |
RISING PHARMA |
|
Approval |
03/01/2019 |
ROSUVASTATIN CALCIUM ANDA #206513 |
ORIG-1 |
ROSUVASTATIN CALCIUM |
ZHEJIANG JINGXIN |
|
Approval |
03/01/2019 |
IMATINIB MESYLATE ANDA #207818 |
ORIG-1 |
IMATINIB MESYLATE |
NATCO PHARMA LTD |
|
Approval |
03/01/2019 |
PHENYLEPHRINE HYDROCHLORIDE NDA #207926 |
SUPPL-2 |
PHENYLEPHRINE HYDROCHLORIDE |
ALCON |
Labeling |
Approval |
03/01/2019 |
XHANCE NDA #209022 |
SUPPL-6 |
FLUTICASONE PROPIONATE |
OPTINOSE US INC |
Manufacturing (CMC) |
Approval |
03/01/2019 |
DAPSONE ANDA #209430 |
ORIG-1 |
DAPSONE |
TARO |
|
Approval |
03/01/2019 |
PANTOPRAZOLE SODIUM ANDA #211368 |
ORIG-1 |
PANTOPRAZOLE SODIUM |
INGENUS PHARMS LLC |
|
Approval |
03/04/2019 |
LUPRON DEPOT NDA #019732 |
SUPPL-44 |
LEUPROLIDE ACETATE |
ABBVIE ENDOCRINE INC |
Labeling |
Approval |
03/04/2019 |
LUPRON DEPOT NDA #020517 |
SUPPL-42 |
LEUPROLIDE ACETATE |
ABBVIE ENDOCRINE INC |
Labeling |
Approval |
03/04/2019 |
TELMISARTAN AND HYDROCHLOROTHIAZIDE ANDA #202544 |
ORIG-1 |
HYDROCHLOROTHIAZIDE; TELMISARTAN |
GLENMARK PHARMS LTD |
|
Approval |
03/04/2019 |
DESVENLAFAXINE SUCCINATE ANDA #204003 |
SUPPL-6 |
DESVENLAFAXINE SUCCINATE |
ALEMBIC |
Labeling |
Approval |
03/04/2019 |
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE ANDA #205769 |
ORIG-1 |
ALISKIREN HEMIFUMARATE;HYDROCHLOROTHIAZIDE |
PAR PHARM INC |
|
Tentative Approval |
03/04/2019 |
RIVASTIGMINE ANDA #206318 |
ORIG-1 |
RIVASTIGMINE |
ZYDUS PHARMS |
|
Approval |
03/04/2019 |
NUPLAZID NDA #207318 |
SUPPL-6 |
PIMAVANSERIN TARTRATE |
ACADIA PHARMS INC |
Labeling |
Approval |
03/04/2019 |
FULVESTRANT ANDA #210044 |
ORIG-1 |
FULVESTRANT |
AMNEAL |
|
Approval |
03/04/2019 |
NUPLAZID NDA #210793 |
SUPPL-1 |
PIMAVANSERIN TARTRATE |
ACADIA PHARMS INC |
Labeling |
Approval |
03/04/2019 |
CLOBETASOL PROPIONATE ANDA #211800 |
ORIG-1 |
CLOBETASOL PROPIONATE |
ALEMBIC |
|
Approval |
03/05/2019 |
LAMIVUDINE ANDA #078545 |
ORIG-1 |
LAMIVUDINE |
MYLAN LABS LTD |
|
Approval |
03/05/2019 |
MOXIFLOXACIN HYDROCHLORIDE NDA #205572 |
SUPPL-5 |
MOXIFLOXACIN HYDROCHLORIDE |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
03/05/2019 |
ZYKADIA NDA #205755 |
SUPPL-16 |
CERITINIB |
NOVARTIS |
Labeling |
Approval |
03/05/2019 |
BEPOTASTINE BESILATE ANDA #206066 |
ORIG-1 |
BEPOTASTINE BESILATE |
APOTEX |
|
Approval |
03/05/2019 |
ESOMEPRAZOLE MAGNESIUM ANDA #209202 |
ORIG-1 |
ESOMEPRAZOLE MAGNESIUM |
P AND L |
|
Approval |
03/05/2019 |
CLONIDINE HYDROCHLORIDE ANDA #209675 |
ORIG-1 |
CLONIDINE HYDROCHLORIDE |
NOVAST LABS |
|
Approval |
03/05/2019 |
PREVYMIS NDA #209939 |
SUPPL-3 |
LETERMOVIR |
MERCK SHARP DOHME |
Labeling |
Approval |
03/05/2019 |
PREVYMIS NDA #209940 |
SUPPL-1 |
LETERMOVIR |
MERCK SHARP DOHME |
Labeling |
Approval |
03/05/2019 |
SPRAVATO NDA #211243 |
ORIG-1 |
ESKETAMINE HYDROCHLORIDE |
JANSSEN PHARMS |
Type 2 - New Active Ingredient |
Approval |
03/06/2019 |
SIMVASTATIN ANDA #078034 |
SUPPL-12 |
SIMVASTATIN |
BIOCON PHARMA |
Labeling |
Approval |
03/06/2019 |
CARVEDILOL ANDA #078251 |
SUPPL-18 |
CARVEDILOL |
GLENMARK PHARMS LTD |
Labeling |
Approval |
03/06/2019 |
TRANEXAMIC ACID ANDA #201885 |
SUPPL-6 |
TRANEXAMIC ACID |
AM REGENT |
Labeling |
Approval |
03/06/2019 |
BUMETANIDE ANDA #202900 |
SUPPL-1 |
BUMETANIDE |
ZYDUS PHARMS |
Labeling |
Approval |
03/06/2019 |
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE ANDA #204802 |
SUPPL-5 |
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
03/06/2019 |
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE ANDA #204802 |
SUPPL-8 |
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
03/06/2019 |
ATORVASTATIN CALCIUM ANDA #204991 |
ORIG-1 |
ATORVASTATIN CALCIUM |
LUPIN LTD |
|
Approval |
03/06/2019 |
SIVEXTRO NDA #205435 |
SUPPL-10 |
TEDIZOLID PHOSPHATE |
CUBIST PHARMS LLC |
Efficacy |
Approval |
03/06/2019 |
SIVEXTRO NDA #205436 |
SUPPL-5 |
TEDIZOLID PHOSPHATE |
CUBIST PHARMS LLC |
Efficacy |
Approval |
03/07/2019 |
IMODIUM A-D NDA #019860 |
SUPPL-33 |
LOPERAMIDE HYDROCHLORIDE |
J AND J CONSUMER INC |
Labeling |
Approval |
03/07/2019 |
OPDIVO BLA #125554 |
SUPPL-42 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
03/07/2019 |
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE ANDA #210899 |
ORIG-1 |
ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE |
LAURUS LABS LTD |
|
Tentative Approval |
03/08/2019 |
HALDOL NDA #015923 |
SUPPL-95 |
HALOPERIDOL LACTATE |
JANSSEN PHARMS |
Labeling |
Approval |
03/08/2019 |
HALDOL NDA #018701 |
SUPPL-73 |
HALOPERIDOL DECANOATE |
JANSSEN PHARMS |
Labeling |
Approval |
03/08/2019 |
SPORANOX NDA #020083 |
SUPPL-63 |
ITRACONAZOLE |
JANSSEN PHARMS |
Labeling |
Approval |
03/08/2019 |
SPORANOX NDA #020657 |
SUPPL-37 |
ITRACONAZOLE |
JANSSEN PHARMS |
Labeling |
Approval |
03/08/2019 |
PARSABIV NDA #208325 |
SUPPL-2 |
ETELCALCETIDE |
KAI PHARMS INC |
Labeling |
Approval |
03/08/2019 |
TOFACITINIB ANDA #209790 |
ORIG-1 |
TOFACITINIB |
SUN PHARM INDS LTD |
|
Tentative Approval |
03/08/2019 |
ATENOLOL AND CHLORTHALIDONE ANDA #210028 |
ORIG-1 |
ATENOLOL; CHLORTHALIDONE |
ZYDUS PHARMS |
|
Approval |
03/08/2019 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #211023 |
ORIG-1 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
WES PHARMA INC |
|
Approval |
03/08/2019 |
FOLIC ACID ANDA #211064 |
ORIG-1 |
FOLIC ACID |
ATHEM |
|
Approval |
03/08/2019 |
PYRIDOSTIGMINE BROMIDE ANDA #211694 |
ORIG-1 |
PYRIDOSTIGMINE BROMIDE |
NOVITIUM PHARMA |
|
Approval |
03/08/2019 |
TECENTRIQ BLA #761034 |
SUPPL-18 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
03/10/2019 |
TORSEMIDE ANDA #076110 |
SUPPL-6 |
TORSEMIDE |
TEVA |
Labeling |
Approval |
03/10/2019 |
ENTECAVIR ANDA #206217 |
SUPPL-2 |
ENTECAVIR |
AUROBINDO PHARMA |
Labeling |
Approval |
03/10/2019 |
ENTECAVIR ANDA #206217 |
SUPPL-5 |
ENTECAVIR |
AUROBINDO PHARMA |
Labeling |
Approval |
03/10/2019 |
ENTECAVIR ANDA #206217 |
SUPPL-6 |
ENTECAVIR |
AUROBINDO PHARMA |
Labeling |
Approval |
03/10/2019 |
ENTECAVIR ANDA #206217 |
SUPPL-7 |
ENTECAVIR |
AUROBINDO PHARMA |
Labeling |
Approval |
03/10/2019 |
ASPIRIN AND DIPYRIDAMOLE ANDA #206753 |
SUPPL-2 |
ASPIRIN; DIPYRIDAMOLE |
ZYDUS PHARMS |
Labeling |
Approval |
03/10/2019 |
ASPIRIN AND DIPYRIDAMOLE ANDA #209048 |
SUPPL-1 |
ASPIRIN; DIPYRIDAMOLE |
DR REDDYS |
Labeling |
Approval |
03/11/2019 |
FASLODEX NDA #021344 |
SUPPL-37 |
FULVESTRANT |
ASTRAZENECA |
Efficacy |
Approval |
03/11/2019 |
NOXAFIL NDA #022003 |
SUPPL-24 |
POSACONAZOLE |
SCHERING |
Labeling |
Approval |
03/11/2019 |
PROCHLORPERAZINE EDISYLATE ANDA #040540 |
SUPPL-16 |
PROCHLORPERAZINE EDISYLATE |
SAGENT |
Manufacturing (CMC) |
Approval |
03/11/2019 |
NIKKI ANDA #201661 |
SUPPL-1 |
DROSPIRENONE; ETHINYL ESTRADIOL |
LUPIN LTD |
Labeling |
Approval |
03/11/2019 |
NIKKI ANDA #201661 |
SUPPL-4 |
DROSPIRENONE; ETHINYL ESTRADIOL |
LUPIN LTD |
Labeling |
Approval |
03/11/2019 |
NIKKI ANDA #201661 |
SUPPL-6 |
DROSPIRENONE; ETHINYL ESTRADIOL |
LUPIN LTD |
Manufacturing (CMC) |
Approval |
03/11/2019 |
MAGNESIUM SULFATE ANDA #202411 |
SUPPL-2 |
MAGNESIUM SULFATE |
HOSPIRA |
Manufacturing (CMC) |
Approval |
03/11/2019 |
EPTIFIBATIDE ANDA #204362 |
ORIG-1 |
EPTIFIBATIDE |
USV |
|
Approval |
03/11/2019 |
NOXAFIL NDA #205053 |
SUPPL-8 |
POSACONAZOLE |
MERCK SHARP DOHME |
Labeling |
Approval |
03/11/2019 |
NOXAFIL NDA #205596 |
SUPPL-7 |
POSACONAZOLE |
MERCK SHARP DOHME |
Labeling |
Approval |
03/11/2019 |
POTASSIUM CHLORIDE ANDA #208445 |
ORIG-1 |
POTASSIUM CHLORIDE |
ZYDUS PHARMS |
|
Approval |
03/11/2019 |
BRIMONIDINE TARTRATE ANDA #208992 |
ORIG-1 |
BRIMONIDINE TARTRATE |
SOMERSET THERAPS LLC |
|
Approval |
03/11/2019 |
BLEOMYCIN SULFATE ANDA #209439 |
ORIG-1 |
BLEOMYCIN SULFATE |
CIPLA |
|
Approval |
03/11/2019 |
DALFAMPRIDINE ANDA #210158 |
ORIG-1 |
DALFAMPRIDINE |
MICRO LABS |
|
Approval |
03/11/2019 |
DUPIXENT BLA #761055 |
SUPPL-12 |
DUPILUMAB |
REGENERON PHARMACEUTICALS |
|
Approval |
03/11/2019 |
AIMOVIG BLA #761077 |
SUPPL-1 |
ERENUMAB-AOOE |
AMGEN INC |
|
Approval |
03/11/2019 |
TRAZIMERA BLA #761081 |
ORIG-1 |
TRASTUZUMAB-QYYP |
PFIZER INC |
|
Approval |
03/12/2019 |
VISIPAQUE 270 NDA #020351 |
SUPPL-48 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
03/12/2019 |
VISIPAQUE 320 NDA #020351 |
SUPPL-48 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
03/12/2019 |
BIDIL NDA #020727 |
SUPPL-10 |
HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE |
AZURITY |
Labeling |
Approval |
03/12/2019 |
VISIPAQUE 270 NDA #020808 |
SUPPL-28 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
03/12/2019 |
VISIPAQUE 320 NDA #020808 |
SUPPL-28 |
IODIXANOL |
GE HEALTHCARE |
Labeling |
Approval |
03/12/2019 |
APRISO NDA #022301 |
SUPPL-14 |
MESALAMINE |
SALIX |
Labeling |
Approval |
03/12/2019 |
VALSARTAN ANDA #205536 |
ORIG-1 |
VALSARTAN |
ALKEM LABS LTD |
|
Approval |
03/12/2019 |
LORATADINE ANDA #207569 |
ORIG-1 |
LORATADINE |
GUARDIAN DRUG |
|
Approval |
03/12/2019 |
ROCKLATAN NDA #208259 |
ORIG-1 |
LATANOPROST; NETARSUDIL DIMESYLATE |
ALCON LABS INC |
New Combination and New Formulation or New Manufacturer |
Approval |
03/12/2019 |
TIZANIDINE HYDROCHLORIDE ANDA #210267 |
ORIG-1 |
TIZANIDINE HYDROCHLORIDE |
NOVAST LABS |
|
Approval |
03/12/2019 |
NIFEDIPINE ANDA #210614 |
ORIG-1 |
NIFEDIPINE |
NOVAST LABS |
|
Approval |
03/12/2019 |
TETRACAINE HYDROCHLORIDE NDA #210821 |
ORIG-1 |
TETRACAINE HYDROCHLORIDE |
BAUSCH LOMB IRELAND |
Type 5 - New Formulation or New Manufacturer |
Approval |
03/12/2019 |
ALLOPURINOL ANDA #211820 |
ORIG-1 |
ALLOPURINOL |
UNICHEM |
|
Approval |
03/12/2019 |
DESONIDE ANDA #212002 |
ORIG-1 |
DESONIDE |
PAI HOLDINGS PHARM |
|
Approval |
03/13/2019 |
NORDETTE-28 NDA #018782 |
SUPPL-39 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
TEVA BRANDED PHARM |
Labeling |
Approval |
03/13/2019 |
FENOGLIDE NDA #022118 |
SUPPL-9 |
FENOFIBRATE |
SALIX |
Labeling |
Approval |
03/13/2019 |
KEMEYA ANDA #202138 |
ORIG-1 |
DROSPIRENONE; ETHINYL ESTRADIOL |
SUN PHARM |
|
Approval |
03/13/2019 |
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER ANDA #209476 |
ORIG-1 |
SODIUM CHLORIDE |
FRESENIUS KABI USA |
|
Approval |
03/13/2019 |
METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE ANDA #209573 |
ORIG-1 |
METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE |
ZYDUS PHARMS USA INC |
|
Tentative Approval |
03/13/2019 |
DOCETAXEL ANDA #209634 |
SUPPL-2 |
DOCETAXEL |
MEITHEAL |
Labeling |
Approval |
03/13/2019 |
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY ANDA #210622 |
ORIG-1 |
CETIRIZINE HYDROCHLORIDE |
HETERO LABS LTD III |
|
Approval |
03/14/2019 |
HELIDAC NDA #050719 |
SUPPL-22 |
BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
CASPER PHARMA LLC |
Labeling |
Approval |
03/14/2019 |
EPTIFIBATIDE ANDA #204361 |
ORIG-1 |
EPTIFIBATIDE |
USV |
|
Approval |
03/14/2019 |
AVYCAZ NDA #206494 |
SUPPL-5 |
AVIBACTAM SODIUM; CEFTAZIDIME |
ALLERGAN |
Efficacy |
Approval |
03/14/2019 |
AVYCAZ NDA #206494 |
SUPPL-6 |
AVIBACTAM SODIUM; CEFTAZIDIME |
ALLERGAN |
Efficacy |
Approval |
03/14/2019 |
ENOXAPARIN SODIUM ANDA #208600 |
ORIG-1 |
ENOXAPARIN SODIUM |
AMPHASTAR PHARMS INC |
|
Approval |
03/14/2019 |
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE ANDA #209252 |
ORIG-1 |
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE |
GLENMARK SPECLT |
|
Approval |
03/15/2019 |
CLARINEX NDA #021165 |
SUPPL-22 |
DESLORATADINE |
ORGANON |
Labeling |
Approval |
03/15/2019 |
CLARINEX NDA #021300 |
SUPPL-19 |
DESLORATADINE |
MERCK SHARP DOHME |
Labeling |
Approval |
03/15/2019 |
CLARINEX NDA #021312 |
SUPPL-20 |
DESLORATADINE |
ORGANON |
Labeling |
Approval |
03/15/2019 |
CLARINEX-D 12 HOUR NDA #021313 |
SUPPL-12 |
DESLORATADINE; PSEUDOEPHEDRINE SULFATE |
ORGANON LLC |
Labeling |
Approval |
03/15/2019 |
CLARINEX NDA #021563 |
SUPPL-8 |
DESLORATADINE |
SCHERING |
Labeling |
Approval |
03/15/2019 |
CLARINEX D 24 HOUR NDA #021605 |
SUPPL-17 |
DESLORATADINE; PSEUDOEPHEDRINE SULFATE |
ORGANON |
Labeling |
Approval |
03/15/2019 |
APTIOM NDA #022416 |
SUPPL-11 |
ESLICARBAZEPINE ACETATE |
SUMITOMO PHARMA AM |
Efficacy |
Approval |
03/15/2019 |
CASPORYN HC NDA #060613 |
SUPPL-14 |
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
CASPER PHARMA LLC |
Manufacturing (CMC) |
Approval |
03/15/2019 |
DIFICID NDA #201699 |
SUPPL-10 |
FIDAXOMICIN |
CUBIST PHARMS LLC |
Labeling |
Approval |
03/15/2019 |
VALSARTAN AND HYDROCHLOROTHIAZIDE ANDA #203000 |
ORIG-1 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
ZYDUS LIFESCIENCES |
|
Approval |
03/15/2019 |
ACYCLOVIR ANDA #205974 |
ORIG-1 |
ACYCLOVIR |
ZYDUS LIFESCIENCES |
|
Approval |
03/15/2019 |
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE NDA #210649 |
ORIG-1 |
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
MACLEODS PHARMS LTD |
Type 5 - New Formulation or New Manufacturer |
Approval |
03/15/2019 |
ALBUTEROL SULFATE ANDA #210948 |
ORIG-1 |
ALBUTEROL SULFATE |
AIZANT |
|
Approval |
03/15/2019 |
AZELAIC ACID ANDA #211077 |
ORIG-1 |
AZELAIC ACID |
PERRIGO PHARMA INTL |
|
Tentative Approval |
03/15/2019 |
AXITINIB ANDA #211650 |
ORIG-1 |
AXITINIB |
APOTEX INC |
|
Tentative Approval |
03/18/2019 |
KYNAMRO NDA #203568 |
SUPPL-11 |
MIPOMERSEN SODIUM |
KASTLE THERAPS LLC |
Labeling |
Approval |
03/18/2019 |
BEPOTASTINE BESILATE ANDA #206220 |
ORIG-1 |
BEPOTASTINE BESILATE |
MYLAN |
|
Approval |
03/18/2019 |
FLUOCINONIDE ANDA #207554 |
ORIG-1 |
FLUOCINONIDE |
PAI HOLDINGS PHARM |
|
Approval |
03/18/2019 |
GENVOYA NDA #207561 |
SUPPL-23 |
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
03/18/2019 |
DIAZEPAM ANDA #210363 |
ORIG-1 |
DIAZEPAM |
BELOTECA |
|
Approval |
03/18/2019 |
ZYKADIA NDA #211225 |
ORIG-1 |
CERITINIB |
NOVARTIS |
|
Approval |
03/18/2019 |
TECENTRIQ BLA #761034 |
SUPPL-19 |
ATEZOLIZUMAB |
GENENTECH INC |
|
Approval |
03/19/2019 |
ALLOPURINOL ANDA #077353 |
SUPPL-6 |
ALLOPURINOL |
CHARTWELL |
Labeling |
Approval |
03/19/2019 |
AMITRIPTYLINE HYDROCHLORIDE ANDA #089399 |
SUPPL-45 |
AMITRIPTYLINE HYDROCHLORIDE |
SUN PHARM INDS INC |
Manufacturing (CMC) |
Approval |
03/19/2019 |
ERTAPENEM SODIUM ANDA #207647 |
ORIG-1 |
ERTAPENEM SODIUM |
SAVIOR LIFETEC CORP |
|
Approval |
03/19/2019 |
LURASIDONE HYDROCHLORIDE ANDA #208052 |
ORIG-1 |
LURASIDONE HYDROCHLORIDE |
ZYDUS PHARMS |
|
Approval |
03/19/2019 |
GLEOLAN NDA #208630 |
SUPPL-4 |
AMINOLEVULINIC ACID HYDROCHLORIDE |
NXDC |
Labeling |
Approval |
03/19/2019 |
ZULRESSO NDA #211371 |
ORIG-1 |
BREXANOLONE |
SAGE THERAP |
Type 1 - New Molecular Entity |
Approval |
03/20/2019 |
ASPIRIN AND DIPYRIDAMOLE ANDA #204552 |
ORIG-1 |
ASPIRIN; DIPYRIDAMOLE |
CHARTWELL MOLECULAR |
|
Approval |
03/20/2019 |
NAFTIFINE HYDROCHLORIDE ANDA #206165 |
ORIG-1 |
NAFTIFINE HYDROCHLORIDE |
AMNEAL |
|
Approval |
03/20/2019 |
AZELASTINE HYDROCHLORIDE ANDA #209620 |
ORIG-1 |
AZELASTINE HYDROCHLORIDE |
ALEMBIC |
|
Approval |
03/20/2019 |
FLUOXETINE HYDROCHLORIDE ANDA #210935 |
ORIG-1 |
FLUOXETINE HYDROCHLORIDE |
SCIEGEN PHARMS INC |
|
Approval |
03/20/2019 |
SUNOSI NDA #211230 |
ORIG-1 |
SOLRIAMFETOL HYDROCHLORIDE |
AXSOME MALTA |
Type 1 - New Molecular Entity |
Approval |
03/20/2019 |
SUNOSI NDA #211230 |
ORIG-2 |
SOLRIAMFETOL HYDROCHLORIDE |
AXSOME MALTA |
Efficacy |
Approval |
03/20/2019 |
METHYLERGONOVINE MALEATE ANDA #211455 |
ORIG-1 |
METHYLERGONOVINE MALEATE |
TEVA PHARMS USA |
|
Approval |
03/20/2019 |
GLYCOPYRROLATE ANDA #211705 |
ORIG-1 |
GLYCOPYRROLATE |
CAPLIN |
|
Approval |
03/20/2019 |
LIBTAYO BLA #761097 |
SUPPL-1 |
CEMIPLIMAB-RWLC |
REGENERON PHARMACEUTICALS |
|
Approval |
03/21/2019 |
PREZISTA NDA #021976 |
SUPPL-53 |
DARUNAVIR |
JANSSEN PRODS |
Efficacy |
Approval |
03/21/2019 |
IBUPROFEN ANDA #071265 |
SUPPL-46 |
IBUPROFEN |
CONTRACT PHARMACAL |
Labeling |
Approval |
03/21/2019 |
IBUPROFEN ANDA #071265 |
SUPPL-48 |
IBUPROFEN |
CONTRACT PHARMACAL |
Labeling |
Approval |
03/21/2019 |
IBUPROFEN ANDA #071265 |
SUPPL-49 |
IBUPROFEN |
CONTRACT PHARMACAL |
Labeling |
Approval |
03/21/2019 |
ORENCIA BLA #125118 |
SUPPL-224 |
ABATACEPT |
BRISTOL MYERS SQUIBB |
|
Approval |
03/21/2019 |
PREZISTA NDA #202895 |
SUPPL-24 |
DARUNAVIR |
JANSSEN PRODS |
Efficacy |
Approval |
03/21/2019 |
RIVASTIGMINE ANDA #207308 |
SUPPL-1 |
RIVASTIGMINE |
AMNEAL PHARMS |
Labeling |
Approval |
03/21/2019 |
DOPTELET NDA #210238 |
SUPPL-2 |
AVATROMBOPAG MALEATE |
AKARX INC |
Labeling |
Approval |
03/21/2019 |
LAMIVUDINE ANDA #211306 |
ORIG-1 |
LAMIVUDINE |
ANNORA |
|
Approval |
03/21/2019 |
RENFLEXIS BLA #761054 |
SUPPL-4 |
INFLIXIMAB-ABDA |
SAMSUNG BIOEPIS CO LTD |
|
Approval |
03/21/2019 |
FULPHILA BLA #761075 |
SUPPL-1 |
PEGFILGRASTIM-JMDB |
MYLAN GMBH |
|
Approval |
03/22/2019 |
PHENDIMETRAZINE TARTRATE NDA #018074 |
SUPPL-36 |
PHENDIMETRAZINE TARTRATE |
VIRTUS |
Labeling |
Approval |
03/22/2019 |
MOMETASONE FUROATE ANDA #076788 |
SUPPL-10 |
MOMETASONE FUROATE |
TARO |
Labeling |
Approval |
03/22/2019 |
AMLODIPINE BESYLATE ANDA #078573 |
SUPPL-17 |
AMLODIPINE BESYLATE |
TORRENT PHARMS |
Labeling |
Approval |
03/22/2019 |
PROPRANOLOL HYDROCHLORIDE ANDA #078703 |
SUPPL-9 |
PROPRANOLOL HYDROCHLORIDE |
ADARE PHARMS INC |
Manufacturing (CMC) |
Approval |
03/22/2019 |
LEVALBUTEROL HYDROCHLORIDE ANDA #090297 |
SUPPL-8 |
LEVALBUTEROL HYDROCHLORIDE |
TEVA PHARMS USA |
Manufacturing (CMC) |
Approval |
03/22/2019 |
PIRMELLA 7/7/7 ANDA #201510 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORETHINDRONE |
LUPIN LTD |
Labeling |
Approval |
03/22/2019 |
PIRMELLA 1/35 ANDA #201512 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORETHINDRONE |
LUPIN LTD |
Labeling |
Approval |
03/22/2019 |
BIMATOPROST ANDA #203604 |
ORIG-1 |
BIMATOPROST |
HI-TECH PHARMACAL |
|
Tentative Approval |
03/22/2019 |
RANITIDINE HYDROCHLORIDE ANDA #205512 |
SUPPL-8 |
RANITIDINE HYDROCHLORIDE |
STRIDES PHARMA |
Manufacturing (CMC) |
Approval |
03/22/2019 |
ALISKIREN HEMIFUMARATE ANDA #206665 |
ORIG-1 |
ALISKIREN HEMIFUMARATE |
ENDO OPERATIONS |
|
Approval |
03/22/2019 |
ROFLUMILAST ANDA #208180 |
ORIG-1 |
ROFLUMILAST |
MICRO LABS |
|
Approval |
03/22/2019 |
RHOPRESSA NDA #208254 |
SUPPL-3 |
NETARSUDIL MESYLATE |
ALCON LABS INC |
Labeling |
Approval |
03/22/2019 |
EZETIMIBE AND SIMVASTATIN ANDA #208831 |
SUPPL-1 |
EZETIMIBE; SIMVASTATIN |
AMNEAL PHARMS CO |
Labeling |
Approval |
03/22/2019 |
BIMATOPROST ANDA #210126 |
ORIG-1 |
BIMATOPROST |
GLAND PHARMA LTD |
|
Approval |
03/22/2019 |
DROSPIRENONE AND ETHINYL ESTRADIOL ANDA #211944 |
ORIG-1 |
DROSPIRENONE; ETHINYL ESTRADIOL |
HETERO LABS |
|
Approval |
03/22/2019 |
SILDENAFIL CITRATE ANDA #212051 |
ORIG-1 |
SILDENAFIL CITRATE |
CHARTWELL RX |
|
Approval |
03/25/2019 |
TACROLIMUS ANDA #065461 |
SUPPL-29 |
TACROLIMUS |
SANDOZ |
Labeling |
Approval |
03/25/2019 |
TACROLIMUS ANDA #065461 |
SUPPL-30 |
TACROLIMUS |
SANDOZ |
Labeling |
Approval |
03/25/2019 |
TRAZODONE HYDROCHLORIDE ANDA #071406 |
SUPPL-6 |
TRAZODONE HYDROCHLORIDE |
NATCO |
Labeling |
Approval |
03/25/2019 |
SILDENAFIL CITRATE ANDA #201171 |
ORIG-1 |
SILDENAFIL CITRATE |
MYLAN |
|
Approval |
03/25/2019 |
ARMODAFINIL ANDA #201514 |
ORIG-1 |
ARMODAFINIL |
COREPHARMA |
|
Approval |
03/25/2019 |
AZELASTINE HYDROCHLORIDE ANDA #204660 |
SUPPL-1 |
AZELASTINE HYDROCHLORIDE |
AMNEAL |
Labeling |
Approval |
03/25/2019 |
AZACITIDINE ANDA #207518 |
SUPPL-4 |
AZACITIDINE |
SHILPA MEDICARE |
Labeling |
Approval |
03/25/2019 |
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE NDA #210796 |
ORIG-1 |
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE |
MACLEODS PHARMS LTD |
Type 4 - New Combination |
Tentative Approval |
03/26/2019 |
ACTHAR GEL NDA #008372 |
SUPPL-61 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Labeling |
Approval |
03/26/2019 |
ACTHAR GEL (AUTOINJECTOR) NDA #008372 |
SUPPL-61 |
CORTICOTROPIN |
MALLINCKRODT ARD |
Labeling |
Approval |
03/26/2019 |
INDOCIN NDA #016059 |
SUPPL-100 |
INDOMETHACIN |
ZYLA LIFE SCIENCES |
Labeling |
Approval |
03/26/2019 |
INDOCIN NDA #017814 |
SUPPL-43 |
INDOMETHACIN |
ZYLA LIFE SCIENCES |
Labeling |
Approval |
03/26/2019 |
INDOCIN SR NDA #018185 |
SUPPL-57 |
INDOMETHACIN |
ZYLA |
Labeling |
Approval |
03/26/2019 |
INDOCIN NDA #018332 |
SUPPL-40 |
INDOMETHACIN |
ZYLA |
Labeling |
Approval |
03/26/2019 |
TAGAMET HB NDA #020238 |
SUPPL-23 |
CIMETIDINE |
MEDTECH PRODUCTS |
Labeling |
Approval |
03/26/2019 |
ERIVEDGE NDA #203388 |
SUPPL-14 |
VISMODEGIB |
GENENTECH |
Labeling |
Approval |
03/26/2019 |
TIVORBEX NDA #204768 |
SUPPL-6 |
INDOMETHACIN |
GENUS |
Labeling |
Approval |
03/26/2019 |
TADALAFIL ANDA #204809 |
ORIG-1 |
TADALAFIL |
ALEMBIC |
|
Approval |
03/26/2019 |
ENTECAVIR ANDA #206226 |
ORIG-1 |
ENTECAVIR |
RISING |
|
Approval |
03/26/2019 |
TADALAFIL ANDA #206285 |
ORIG-1 |
TADALAFIL |
AUROBINDO PHARMA LTD |
|
Approval |
03/26/2019 |
TADALAFIL ANDA #206693 |
ORIG-1 |
TADALAFIL |
ZYDUS PHARMS |
|
Approval |
03/26/2019 |
TADALAFIL ANDA #208934 |
ORIG-1 |
TADALAFIL |
SUN PHARM |
|
Approval |
03/26/2019 |
TADALAFIL ANDA #209167 |
ORIG-1 |
TADALAFIL |
ACCORD HLTHCARE |
|
Approval |
03/26/2019 |
TADALAFIL ANDA #209250 |
ORIG-1 |
TADALAFIL |
UNICHEM |
|
Approval |
03/26/2019 |
TADALAFIL ANDA #209539 |
ORIG-1 |
TADALAFIL |
CIPLA |
|
Approval |
03/26/2019 |
TADALAFIL ANDA #209654 |
ORIG-1 |
TADALAFIL |
AJANTA PHARMA LTD |
|
Approval |
03/26/2019 |
TADALAFIL ANDA #209744 |
ORIG-1 |
TADALAFIL |
AMNEAL PHARMS CO |
|
Approval |
03/26/2019 |
MAYZENT NDA #209884 |
ORIG-1 |
SIPONIMOD |
NOVARTIS |
Type 1 - New Molecular Entity |
Approval |
03/26/2019 |
TADALAFIL ANDA #209908 |
ORIG-1 |
TADALAFIL |
HETERO LABS LTD III |
|
Approval |
03/26/2019 |
TIZANIDINE HYDROCHLORIDE ANDA #210021 |
ORIG-1 |
TIZANIDINE HYDROCHLORIDE |
CADILA PHARMS LTD |
|
Approval |
03/26/2019 |
TADALAFIL ANDA #210069 |
ORIG-1 |
TADALAFIL |
DR REDDYS |
|
Approval |
03/26/2019 |
CEPHALEXIN ANDA #210221 |
ORIG-1 |
CEPHALEXIN |
ALKEM LABS LTD |
|
Approval |
03/26/2019 |
TADALAFIL ANDA #210420 |
ORIG-1 |
TADALAFIL |
QILU PHARM HAINAN |
|
Approval |
03/26/2019 |
TADALAFIL ANDA #210567 |
ORIG-1 |
TADALAFIL |
LUPIN LTD |
|
Approval |
03/26/2019 |
TADALAFIL ANDA #211335 |
ORIG-1 |
TADALAFIL |
SUNSHINE |
|
Approval |
03/26/2019 |
TADALAFIL ANDA #211839 |
ORIG-1 |
TADALAFIL |
TORRENT |
|
Approval |
03/26/2019 |
TADALAFIL ANDA #212062 |
ORIG-1 |
TADALAFIL |
TORRENT |
|
Approval |
03/27/2019 |
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #020255 |
SUPPL-20 |
DOBUTAMINE HYDROCHLORIDE |
BAXTER HLTHCARE |
Labeling |
Approval |
03/27/2019 |
DOCETAXEL NDA #201525 |
SUPPL-16 |
DOCETAXEL |
SANDOZ |
Labeling |
Approval |
03/27/2019 |
DOCETAXEL NDA #201525 |
SUPPL-17 |
DOCETAXEL |
SANDOZ |
Labeling |
Approval |
03/27/2019 |
JATENZO NDA #206089 |
ORIG-1 |
TESTOSTERONE UNDECANOATE |
TOLMAR |
Type 3 - New Dosage Form |
Approval |
03/27/2019 |
EZALLOR SPRINKLE NDA #208647 |
SUPPL-1 |
ROSUVASTATIN CALCIUM |
SUN PHARM |
Labeling |
Approval |
03/27/2019 |
ATAZANAVIR; COBICISTAT ANDA #211124 |
ORIG-1 |
ATAZANAVIR;COBICISTAT |
MYLAN PHARMS INC |
|
Tentative Approval |
03/27/2019 |
DOXEPIN HYDROCHLORIDE ANDA #211603 |
ORIG-1 |
DOXEPIN HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
|
Approval |
03/27/2019 |
TIZANIDINE HYDROCHLORIDE ANDA #212196 |
ORIG-1 |
TIZANIDINE HYDROCHLORIDE |
ALKEM LABS LTD |
|
Approval |
03/28/2019 |
INVIRASE NDA #020628 |
SUPPL-47 |
SAQUINAVIR MESYLATE |
HOFFMANN LA ROCHE |
Labeling |
Approval |
03/28/2019 |
TRICOR NDA #021203 |
SUPPL-9 |
FENOFIBRATE |
ABBVIE |
Labeling |
Approval |
03/28/2019 |
LEXIVA NDA #021548 |
SUPPL-41 |
FOSAMPRENAVIR CALCIUM |
VIIV HLTHCARE |
Labeling |
Approval |
03/28/2019 |
TRICOR NDA #021656 |
SUPPL-29 |
FENOFIBRATE |
ABBVIE |
Labeling |
Approval |
03/28/2019 |
INVIRASE NDA #021785 |
SUPPL-23 |
SAQUINAVIR MESYLATE |
HOFFMANN-LA ROCHE |
Labeling |
Approval |
03/28/2019 |
LETAIRIS NDA #022081 |
SUPPL-39 |
AMBRISENTAN |
GILEAD |
REMS |
Approval |
03/28/2019 |
LEXIVA NDA #022116 |
SUPPL-25 |
FOSAMPRENAVIR CALCIUM |
VIIV HLTHCARE |
Labeling |
Approval |
03/28/2019 |
TRILIPIX NDA #022224 |
SUPPL-15 |
CHOLINE FENOFIBRATE |
ABBVIE |
Labeling |
Approval |
03/28/2019 |
EFFIENT NDA #022307 |
SUPPL-16 |
PRASUGREL HYDROCHLORIDE |
COSETTE |
Labeling |
Approval |
03/28/2019 |
CIMZIA BLA #125160 |
SUPPL-237 |
CERTOLIZUMAB PEGOL |
UCB INC |
|
Approval |
03/28/2019 |
GRANIX BLA #125294 |
SUPPL-46 |
TBO-FILGRASTIM |
SICOR BIOTECH |
|
Approval |
03/28/2019 |
AMBRISENTAN ANDA #208252 |
ORIG-1 |
AMBRISENTAN |
WATSON LABS INC |
|
Approval |
03/28/2019 |
AMBRISENTAN ANDA #208441 |
ORIG-1 |
AMBRISENTAN |
MYLAN |
|
Approval |
03/28/2019 |
AMBRISENTAN ANDA #210058 |
ORIG-1 |
AMBRISENTAN |
ZYDUS PHARMS |
|
Approval |
03/28/2019 |
AMBRISENTAN ANDA #210784 |
ORIG-1 |
AMBRISENTAN |
SUN PHARM |
|
Approval |
03/28/2019 |
LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #211983 |
ORIG-1 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
PERRIGO R AND D |
|
Approval |
03/29/2019 |
LAMISIL NDA #020539 |
SUPPL-33 |
TERBINAFINE HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
03/29/2019 |
ZELNORM NDA #021200 |
SUPPL-15 |
TEGASEROD MALEATE |
ALFASIGMA |
Efficacy |
Approval |
03/29/2019 |
SENSIPAR NDA #021688 |
SUPPL-25 |
CINACALCET HYDROCHLORIDE |
AMGEN |
Labeling |
Approval |
03/29/2019 |
SENSIPAR NDA #021688 |
SUPPL-26 |
CINACALCET HYDROCHLORIDE |
AMGEN |
Labeling |
Approval |
03/29/2019 |
LAMISIL NDA #022071 |
SUPPL-15 |
TERBINAFINE HYDROCHLORIDE |
NOVARTIS |
Labeling |
Approval |
03/29/2019 |
MAVENCLAD NDA #022561 |
ORIG-1 |
CLADRIBINE |
EMD SERONO INC |
Type 3 - New Dosage Form |
Approval |
03/29/2019 |
POLYMYXIN B SULFATE ANDA #060716 |
SUPPL-26 |
POLYMYXIN B SULFATE |
HIKMA |
Manufacturing (CMC) |
Approval |
03/29/2019 |
VENLAFAXINE HYDROCHLORIDE ANDA #091272 |
SUPPL-14 |
VENLAFAXINE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
03/29/2019 |
VENLAFAXINE HYDROCHLORIDE ANDA #091272 |
SUPPL-15 |
VENLAFAXINE HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
03/29/2019 |
VENLAFAXINE HYDROCHLORIDE ANDA #091272 |
SUPPL-18 |
VENLAFAXINE HYDROCHLORIDE |
SUN PHARM |
Manufacturing (CMC) |
Approval |
03/29/2019 |
AVACLYR NDA #202408 |
ORIG-1 |
ACYCLOVIR |
FERA PHARMS LLC |
Type 3 - New Dosage Form |
Approval |
03/29/2019 |
TUDORZA PRESSAIR NDA #202450 |
SUPPL-12 |
ACLIDINIUM BROMIDE |
COVIS |
Efficacy |
Approval |
03/29/2019 |
TADALAFIL ANDA #205885 |
ORIG-1 |
TADALAFIL |
WATSON LABS INC |
|
Approval |
03/29/2019 |
POTASSIUM CHLORIDE ANDA #206630 |
ORIG-1 |
POTASSIUM CHLORIDE |
CHARTWELL RX |
|
Approval |
03/29/2019 |
RASAGILINE MESYLATE ANDA #207004 |
ORIG-1 |
RASAGILINE MESYLATE |
MICRO LABS |
|
Approval |
03/29/2019 |
AZELASTINE HYDROCHLORIDE ANDA #207411 |
ORIG-1 |
AZELASTINE HYDROCHLORIDE |
SOMERSET THERAPS LLC |
|
Approval |
03/29/2019 |
DUAKLIR PRESSAIR NDA #210595 |
ORIG-1 |
ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE |
COVIS |
Type 4 - New Combination |
Approval |
03/29/2019 |
POTASSIUM CHLORIDE ANDA #210766 |
ORIG-1 |
POTASSIUM CHLORIDE |
PHARM ASSOC |
|
Approval |