| 12/01/2015 |
RITALIN-SR
NDA #018029 |
SUPPL-52 |
METHYLPHENIDATE HYDROCHLORIDE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
| 12/01/2015 |
NOVOLIN R
BLA #019938 |
SUPPL-73 |
INSULIN RECOMBINANT HUMAN |
NOVO NORDISK INC |
|
Approval |
| 12/01/2015 |
ORTHO-CEPT
NDA #020301 |
SUPPL-36 |
DESOGESTREL; ETHINYL ESTRADIOL |
JANSSEN PHARMS |
Labeling |
Approval |
| 12/01/2015 |
THALOMID
NDA #020785 |
SUPPL-59 |
THALIDOMIDE |
BRISTOL-MYERS |
REMS |
Approval |
| 12/01/2015 |
REVLIMID
NDA #021880 |
SUPPL-46 |
LENALIDOMIDE |
BRISTOL MYERS SQUIBB |
REMS |
Approval |
| 12/01/2015 |
ARGATROBAN IN SODIUM CHLORIDE
NDA #022485 |
SUPPL-5 |
ARGATROBAN |
SANDOZ |
Manufacturing (CMC) |
Approval |
| 12/01/2015 |
VALPROIC ACID
ANDA #074060 |
SUPPL-4 |
VALPROIC ACID |
HIKMA |
Labeling |
Approval |
| 12/01/2015 |
VALPROIC ACID
ANDA #074060 |
SUPPL-6 |
VALPROIC ACID |
HIKMA |
Manufacturing (CMC) |
Approval |
| 12/01/2015 |
VALPROIC ACID
ANDA #074060 |
SUPPL-7 |
VALPROIC ACID |
HIKMA |
Labeling |
Approval |
| 12/01/2015 |
VALPROIC ACID
ANDA #074060 |
SUPPL-9 |
VALPROIC ACID |
HIKMA |
Labeling |
Approval |
| 12/01/2015 |
VALPROIC ACID
ANDA #074060 |
SUPPL-10 |
VALPROIC ACID |
HIKMA |
Labeling |
Approval |
| 12/01/2015 |
VALPROIC ACID
ANDA #074060 |
SUPPL-12 |
VALPROIC ACID |
HIKMA |
Labeling |
Approval |
| 12/01/2015 |
VALPROIC ACID
ANDA #074060 |
SUPPL-13 |
VALPROIC ACID |
HIKMA |
Labeling |
Approval |
| 12/01/2015 |
VALPROIC ACID
ANDA #074060 |
SUPPL-14 |
VALPROIC ACID |
HIKMA |
Labeling |
Approval |
| 12/01/2015 |
CIPROFLOXACIN
ANDA #076126 |
SUPPL-11 |
CIPROFLOXACIN |
CARLSBAD |
Labeling |
Approval |
| 12/01/2015 |
CIPROFLOXACIN
ANDA #076126 |
SUPPL-12 |
CIPROFLOXACIN |
CARLSBAD |
Labeling |
Approval |
| 12/01/2015 |
CIPROFLOXACIN HYDROCHLORIDE
ANDA #076126 |
SUPPL-11 |
CIPROFLOXACIN HYDROCHLORIDE |
CARLSBAD |
Labeling |
Approval |
| 12/01/2015 |
CIPROFLOXACIN HYDROCHLORIDE
ANDA #076126 |
SUPPL-12 |
CIPROFLOXACIN HYDROCHLORIDE |
CARLSBAD |
Labeling |
Approval |
| 12/01/2015 |
MODAFINIL
ANDA #076594 |
SUPPL-4 |
MODAFINIL |
NATCO PHARMA |
Labeling |
Approval |
| 12/01/2015 |
CITALOPRAM HYDROBROMIDE
ANDA #077042 |
SUPPL-24 |
CITALOPRAM HYDROBROMIDE |
MYLAN |
Labeling |
Approval |
| 12/01/2015 |
PRAVASTATIN SODIUM
ANDA #077491 |
SUPPL-3 |
PRAVASTATIN SODIUM |
APNAR PHARMA LP |
Labeling |
Approval |
| 12/01/2015 |
PRAVASTATIN SODIUM
ANDA #077491 |
SUPPL-4 |
PRAVASTATIN SODIUM |
APNAR PHARMA LP |
Labeling |
Approval |
| 12/01/2015 |
VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #078020 |
SUPPL-8 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
MYLAN PHARMS INC |
Labeling |
Approval |
| 12/01/2015 |
PRAVASTATIN SODIUM
ANDA #079187 |
SUPPL-2 |
PRAVASTATIN SODIUM |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
| 12/01/2015 |
ACETAMINOPHEN AND CODEINE PHOSPHATE
ANDA #087508 |
SUPPL-35 |
ACETAMINOPHEN; CODEINE PHOSPHATE |
GENUS LIFESCIENCES |
Labeling |
Approval |
| 12/01/2015 |
LEVETIRACETAM
ANDA #090601 |
SUPPL-2 |
LEVETIRACETAM |
HIKMA |
Labeling |
Approval |
| 12/01/2015 |
LEVETIRACETAM
ANDA #090601 |
SUPPL-4 |
LEVETIRACETAM |
HIKMA |
Manufacturing (CMC) |
Approval |
| 12/01/2015 |
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #091155 |
SUPPL-2 |
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
| 12/01/2015 |
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #091155 |
SUPPL-4 |
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
| 12/01/2015 |
AVASTIN
BLA #125085 |
SUPPL-312 |
BEVACIZUMAB |
GENENTECH |
|
Approval |
| 12/01/2015 |
GLUCAGON
NDA #201849 |
SUPPL-2 |
GLUCAGON HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
| 12/01/2015 |
VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203026 |
SUPPL-2 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
APOTEX INC |
Labeling |
Approval |
| 12/01/2015 |
VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203026 |
SUPPL-3 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
APOTEX INC |
Labeling |
Approval |
| 12/01/2015 |
VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203026 |
SUPPL-4 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
APOTEX INC |
Labeling |
Approval |
| 12/01/2015 |
VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #203026 |
SUPPL-5 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
APOTEX INC |
Labeling |
Approval |
| 12/01/2015 |
ICLUSIG
NDA #203469 |
SUPPL-19 |
PONATINIB HYDROCHLORIDE |
TAKEDA PHARMS USA |
Manufacturing (CMC) |
Approval |
| 12/01/2015 |
DONEPEZIL HYDROCHLORIDE
ANDA #203907 |
SUPPL-5 |
DONEPEZIL HYDROCHLORIDE |
SCIEGEN PHARMS INC |
Labeling |
Approval |
| 12/01/2015 |
POMALYST
NDA #204026 |
SUPPL-11 |
POMALIDOMIDE |
BRISTOL |
REMS |
Approval |
| 12/01/2015 |
DEXAMETHASONE SODIUM PHOSPHATE
ANDA #206781 |
ORIG-1 |
DEXAMETHASONE SODIUM PHOSPHATE |
EUGIA PHARMA |
|
Approval |
| 12/02/2015 |
METHOTREXATE SODIUM
NDA #008085 |
SUPPL-65 |
METHOTREXATE SODIUM |
STRIDES PHARMA |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
HEPARIN SODIUM
NDA #017037 |
SUPPL-174 |
HEPARIN SODIUM |
HIKMA |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
NUTRILIPID 10%
NDA #019531 |
SUPPL-3 |
SOYBEAN OIL |
B BRAUN |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
NUTRILIPID 20%
NDA #019531 |
SUPPL-3 |
SOYBEAN OIL |
B BRAUN |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
IMODIUM MULTI-SYMPTOM RELIEF
NDA #021140 |
SUPPL-24 |
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE |
J AND J CONSUMER INC |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
STARLIX
NDA #021204 |
SUPPL-18 |
NATEGLINIDE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
INFUVITE PEDIATRIC
NDA #021265 |
SUPPL-31 |
ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K |
SANDOZ CANADA INC |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
NDA #021265 |
SUPPL-31 |
ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K |
SANDOZ CANADA INC |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
FUZEON
NDA #021481 |
SUPPL-30 |
ENFUVIRTIDE |
ROCHE |
Labeling |
Approval |
| 12/02/2015 |
ERAXIS
NDA #021632 |
SUPPL-21 |
ANIDULAFUNGIN |
VICURON HOLDINGS |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
KALETRA
NDA #021906 |
SUPPL-45 |
LOPINAVIR; RITONAVIR |
ABBVIE |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
KARBINAL ER
NDA #022556 |
SUPPL-2 |
CARBINOXAMINE MALEATE |
AYTU |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
VIREAD
NDA #022577 |
SUPPL-8 |
TENOFOVIR DISOPROXIL FUMARATE |
GILEAD SCIENCES INC |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
RIFADIN
NDA #050627 |
SUPPL-16 |
RIFAMPIN |
SANOFI AVENTIS US |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
DESMOPRESSIN ACETATE
ANDA #076470 |
SUPPL-21 |
DESMOPRESSIN ACETATE |
ACTAVIS LABS FL INC |
Labeling |
Approval |
| 12/02/2015 |
GEMCITABINE HYDROCHLORIDE
ANDA #078759 |
SUPPL-1 |
GEMCITABINE HYDROCHLORIDE |
TEYRO LABS |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
DULOXETINE HYDROCHLORIDE
ANDA #090694 |
SUPPL-3 |
DULOXETINE HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
| 12/02/2015 |
DULOXETINE HYDROCHLORIDE
ANDA #090694 |
SUPPL-4 |
DULOXETINE HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
| 12/02/2015 |
DULOXETINE HYDROCHLORIDE
ANDA #090694 |
SUPPL-5 |
DULOXETINE HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
| 12/02/2015 |
DULOXETINE HYDROCHLORIDE
ANDA #090694 |
SUPPL-6 |
DULOXETINE HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
| 12/02/2015 |
DULOXETINE HYDROCHLORIDE
ANDA #090694 |
SUPPL-7 |
DULOXETINE HYDROCHLORIDE |
LUPIN LTD |
Labeling |
Approval |
| 12/02/2015 |
RAMIPRIL
ANDA #091069 |
ORIG-1 |
RAMIPRIL |
APOTEX |
|
Approval |
| 12/02/2015 |
SPIRONOLACTONE
ANDA #091426 |
SUPPL-3 |
SPIRONOLACTONE |
AMNEAL PHARMS |
Labeling |
Approval |
| 12/02/2015 |
SPIRONOLACTONE
ANDA #091426 |
SUPPL-4 |
SPIRONOLACTONE |
AMNEAL PHARMS |
Labeling |
Approval |
| 12/02/2015 |
SPIRONOLACTONE
ANDA #091426 |
SUPPL-5 |
SPIRONOLACTONE |
AMNEAL PHARMS |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
SPIRONOLACTONE
ANDA #091426 |
SUPPL-6 |
SPIRONOLACTONE |
AMNEAL PHARMS |
Labeling |
Approval |
| 12/02/2015 |
SPIRONOLACTONE
ANDA #091426 |
SUPPL-7 |
SPIRONOLACTONE |
AMNEAL PHARMS |
Labeling |
Approval |
| 12/02/2015 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202164 |
SUPPL-4 |
PRAMIPEXOLE DIHYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 12/02/2015 |
PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202164 |
SUPPL-6 |
PRAMIPEXOLE DIHYDROCHLORIDE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 12/02/2015 |
JAKAFI
NDA #202192 |
SUPPL-10 |
RUXOLITINIB PHOSPHATE |
INCYTE CORP |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
PROLENSA
NDA #203168 |
SUPPL-3 |
BROMFENAC SODIUM |
BAUSCH AND LOMB |
Manufacturing (CMC) |
Approval |
| 12/02/2015 |
ICLUSIG
NDA #203469 |
SUPPL-20 |
PONATINIB HYDROCHLORIDE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 12/02/2015 |
DICLOFENAC SODIUM
ANDA #206493 |
ORIG-1 |
DICLOFENAC SODIUM |
ACTAVIS MID ATLANTIC |
|
Approval |
| 12/03/2015 |
NOR-QD
NDA #017060 |
SUPPL-83 |
NORETHINDRONE |
TEVA BRANDED PHARM |
Manufacturing (CMC) |
Approval |
| 12/03/2015 |
COPAXONE
NDA #020622 |
SUPPL-95 |
GLATIRAMER ACETATE |
TEVA PHARMS USA |
Manufacturing (CMC) |
Approval |
| 12/03/2015 |
AMOXIL
NDA #050542 |
SUPPL-30 |
AMOXICILLIN |
US ANTIBIOTICS |
Labeling |
Approval |
| 12/03/2015 |
AMOXIL
NDA #050754 |
SUPPL-20 |
AMOXICILLIN |
US ANTIBIOTICS |
Labeling |
Approval |
| 12/03/2015 |
AMOXIL
NDA #050760 |
SUPPL-20 |
AMOXICILLIN |
US ANTIBIOTICS |
Labeling |
Approval |
| 12/03/2015 |
AMOXIL
NDA #050761 |
SUPPL-17 |
AMOXICILLIN |
US ANTIBIOTICS |
Labeling |
Approval |
| 12/03/2015 |
ETODOLAC
ANDA #075104 |
SUPPL-8 |
ETODOLAC |
NATCO PHARMA |
Labeling |
Approval |
| 12/03/2015 |
MIRTAZAPINE
ANDA #077666 |
SUPPL-9 |
MIRTAZAPINE |
APOTEX INC |
Labeling |
Approval |
| 12/03/2015 |
OXCARBAZEPINE
ANDA #078069 |
SUPPL-8 |
OXCARBAZEPINE |
BRECKENRIDGE PHARM |
Labeling |
Approval |
| 12/03/2015 |
OXCARBAZEPINE
ANDA #078069 |
SUPPL-9 |
OXCARBAZEPINE |
BRECKENRIDGE PHARM |
Labeling |
Approval |
| 12/03/2015 |
IMATINIB MESYLATE
ANDA #078340 |
ORIG-1 |
IMATINIB MESYLATE |
SUN PHARM |
|
Approval |
| 12/03/2015 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #078466 |
SUPPL-13 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
LUPIN PHARMS |
Labeling |
Approval |
| 12/03/2015 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #078466 |
SUPPL-14 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
LUPIN PHARMS |
Labeling |
Approval |
| 12/03/2015 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
ANDA #078466 |
SUPPL-17 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
LUPIN PHARMS |
Labeling |
Approval |
| 12/03/2015 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
ANDA #078466 |
SUPPL-13 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
LUPIN PHARMS |
Labeling |
Approval |
| 12/03/2015 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
ANDA #078466 |
SUPPL-14 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
LUPIN PHARMS |
Labeling |
Approval |
| 12/03/2015 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
ANDA #078466 |
SUPPL-17 |
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE |
LUPIN PHARMS |
Labeling |
Approval |
| 12/03/2015 |
LAX-LYTE WITH FLAVOR PACKS
ANDA #079232 |
SUPPL-2 |
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
L PERRIGO CO |
Labeling |
Approval |
| 12/03/2015 |
TOPOTECAN HYDROCHLORIDE
ANDA #091542 |
SUPPL-1 |
TOPOTECAN HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 12/03/2015 |
TOPOTECAN HYDROCHLORIDE
ANDA #091542 |
SUPPL-4 |
TOPOTECAN HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 12/03/2015 |
XOLAIR
BLA #103976 |
SUPPL-5224 |
OMALIZUMAB |
GENENTECH |
|
Approval |
| 12/03/2015 |
SOLIRIS
BLA #125166 |
SUPPL-412 |
ECULIZUMAB |
ALEXION PHARM |
|
Approval |
| 12/03/2015 |
SOLIRIS
BLA #125166 |
SUPPL-413 |
ECULIZUMAB |
ALEXION PHARM |
|
Approval |
| 12/03/2015 |
AMLODIPINE BESYLATE
ANDA #201380 |
SUPPL-5 |
AMLODIPINE BESYLATE |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 12/03/2015 |
INJECTAFER
NDA #203565 |
SUPPL-3 |
FERRIC CARBOXYMALTOSE |
AM REGENT |
Manufacturing (CMC) |
Approval |
| 12/03/2015 |
EPINEPHRINE
NDA #205029 |
SUPPL-3 |
EPINEPHRINE |
BPI LABS |
Manufacturing (CMC) |
Approval |
| 12/04/2015 |
AN-SULFUR COLLOID
NDA #017858 |
SUPPL-45 |
TECHNETIUM TC-99M SULFUR COLLOID KIT |
SUN PHARM INDS INC |
Manufacturing (CMC) |
Approval |
| 12/04/2015 |
CHILDREN'S MOTRIN
NDA #020603 |
SUPPL-18 |
IBUPROFEN |
J AND J CONSUMER INC |
Manufacturing (CMC) |
Approval |
| 12/04/2015 |
FOCALIN
NDA #021278 |
SUPPL-20 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
SANDOZ |
Manufacturing (CMC) |
Approval |
| 12/04/2015 |
TRACLEER
NDA #021290 |
SUPPL-27 |
BOSENTAN |
ACTELION |
REMS |
Approval |
| 12/04/2015 |
TRACLEER
NDA #021290 |
SUPPL-29 |
BOSENTAN |
ACTELION |
Labeling |
Approval |
| 12/04/2015 |
FOCALIN XR
NDA #021802 |
SUPPL-31 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
SANDOZ |
Manufacturing (CMC) |
Approval |
| 12/04/2015 |
VYVANSE
NDA #021977 |
SUPPL-40 |
LISDEXAMFETAMINE DIMESYLATE |
TAKEDA PHARMS USA |
Manufacturing (CMC) |
Approval |
| 12/04/2015 |
ZIPRASIDONE HYDROCHLORIDE
ANDA #077562 |
SUPPL-11 |
ZIPRASIDONE HYDROCHLORIDE |
SANDOZ INC |
Labeling |
Approval |
| 12/04/2015 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078211 |
SUPPL-8 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 12/04/2015 |
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ANDA #078211 |
SUPPL-9 |
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 12/04/2015 |
FARXIGA
NDA #202293 |
SUPPL-8 |
DAPAGLIFLOZIN |
ASTRAZENECA AB |
Labeling |
Approval |
| 12/04/2015 |
ELIFEMME
ANDA #202507 |
ORIG-1 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
XIROMED |
|
Approval |
| 12/04/2015 |
QUININE SULFATE
ANDA #202581 |
SUPPL-4 |
QUININE SULFATE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 12/04/2015 |
OXTELLAR XR
NDA #202810 |
SUPPL-5 |
OXCARBAZEPINE |
SUPERNUS PHARMS |
Labeling |
Approval |
| 12/04/2015 |
TELMISARTAN
ANDA #203325 |
SUPPL-1 |
TELMISARTAN |
ZYDUS PHARMS |
Labeling |
Approval |
| 12/04/2015 |
ALLZITAL
ANDA #203484 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL |
LARKEN LABS INC |
|
Approval |
| 12/04/2015 |
BUTALBITAL AND ACETAMINOPHEN
ANDA #203484 |
ORIG-1 |
ACETAMINOPHEN; BUTALBITAL |
LARKEN LABS INC |
|
Approval |
| 12/04/2015 |
INVOKANA
NDA #204042 |
SUPPL-13 |
CANAGLIFLOZIN |
JANSSEN PHARMS |
Labeling |
Approval |
| 12/04/2015 |
INVOKAMET
NDA #204353 |
SUPPL-12 |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
JANSSEN PHARMS |
Labeling |
Approval |
| 12/04/2015 |
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #204534 |
ORIG-1 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
NOVEL LABS INC |
|
Approval |
| 12/04/2015 |
JARDIANCE
NDA #204629 |
SUPPL-7 |
EMPAGLIFLOZIN |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 12/04/2015 |
ADEMPAS
NDA #204819 |
SUPPL-4 |
RIOCIGUAT |
BAYER HLTHCARE |
REMS |
Approval |
| 12/04/2015 |
XIGDUO XR
NDA #205649 |
SUPPL-3 |
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
ASTRAZENECA AB |
Labeling |
Approval |
| 12/04/2015 |
GLYXAMBI
NDA #206073 |
SUPPL-3 |
EMPAGLIFLOZIN; LINAGLIPTIN |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 12/04/2015 |
SYNJARDY
NDA #206111 |
SUPPL-2 |
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 12/04/2015 |
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #206931 |
ORIG-1 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
ABHAI INC |
|
Approval |
| 12/04/2015 |
TUZISTRA XR
NDA #207768 |
SUPPL-1 |
CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX |
TRIS PHARMA INC |
Manufacturing (CMC) |
Approval |
| 12/04/2015 |
QUILLICHEW ER
NDA #207960 |
ORIG-1 |
METHYLPHENIDATE HYDROCHLORIDE |
NEXTWAVE PHARMS |
Type 3 - New Dosage Form |
Approval |
| 12/07/2015 |
MAGNEVIST
NDA #019596 |
SUPPL-58 |
GADOPENTETATE DIMEGLUMINE |
BAYER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 12/07/2015 |
CHILDREN'S MOTRIN
NDA #020516 |
SUPPL-31 |
IBUPROFEN |
J AND J CONSUMER INC |
Manufacturing (CMC) |
Approval |
| 12/07/2015 |
ONDANSETRON
ANDA #078139 |
SUPPL-5 |
ONDANSETRON |
MYLAN |
Labeling |
Approval |
| 12/07/2015 |
OLOPATADINE HYDROCHLORIDE
ANDA #078350 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
APOTEX |
|
Approval |
| 12/07/2015 |
METHOCARBAMOL
ANDA #085159 |
SUPPL-51 |
METHOCARBAMOL |
HIKMA INTL PHARMS |
Labeling |
Approval |
| 12/07/2015 |
PANTOPRAZOLE SODIUM
ANDA #090901 |
SUPPL-12 |
PANTOPRAZOLE SODIUM |
JUBILANT GENERICS |
Labeling |
Approval |
| 12/07/2015 |
AMPICILLIN AND SULBACTAM
ANDA #201406 |
ORIG-1 |
AMPICILLIN SODIUM; SULBACTAM SODIUM |
ANTIBIOTICE |
|
Approval |
| 12/07/2015 |
ZIPRASIDONE HYDROCHLORIDE
ANDA #202395 |
SUPPL-2 |
ZIPRASIDONE HYDROCHLORIDE |
MYLAN |
Labeling |
Approval |
| 12/07/2015 |
XALKORI
NDA #202570 |
SUPPL-15 |
CRIZOTINIB |
PF PRISM CV |
Manufacturing (CMC) |
Approval |
| 12/07/2015 |
IRBESARTAN
ANDA #203020 |
ORIG-1 |
IRBESARTAN |
UNICHEM |
|
Approval |
| 12/07/2015 |
OLOPATADINE HYDROCHLORIDE
ANDA #203152 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
USV |
|
Approval |
| 12/07/2015 |
MONTELUKAST SODIUM
ANDA #203795 |
SUPPL-1 |
MONTELUKAST SODIUM |
JUBILANT GENERICS |
Labeling |
Approval |
| 12/07/2015 |
OLOPATADINE HYDROCHLORIDE
ANDA #204706 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
ZAMBON SPA |
|
Approval |
| 12/07/2015 |
IRBESARTAN
ANDA #204774 |
ORIG-1 |
IRBESARTAN |
SCIEGEN PHARMS INC |
|
Approval |
| 12/07/2015 |
LEVOTHYROXINE SODIUM
ANDA #205366 |
ORIG-1 |
LEVOTHYROXINE SODIUM |
ENDO OPERATIONS |
|
Approval |
| 12/07/2015 |
LEVOTHYROXINE SODIUM
ANDA #205366 |
ORIG-2 |
LEVOTHYROXINE SODIUM |
ENDO OPERATIONS |
|
Tentative Approval |
| 12/07/2015 |
MEMANTINE HYDROCHLORIDE
ANDA #205446 |
ORIG-1 |
MEMANTINE HYDROCHLORIDE |
SCIEGEN PHARMS INC |
|
Approval |
| 12/07/2015 |
OLOPATADINE HYDROCHLORIDE
ANDA #206306 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
SOMERSET THERAPS LLC |
|
Approval |
| 12/07/2015 |
BENDEKA
NDA #208194 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
EAGLE PHARMS |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 12/08/2015 |
METRO I.V. IN PLASTIC CONTAINER
NDA #018900 |
SUPPL-31 |
METRONIDAZOLE |
B BRAUN |
Labeling |
Approval |
| 12/08/2015 |
VIVITROL
NDA #021897 |
SUPPL-29 |
NALTREXONE |
ALKERMES |
Manufacturing (CMC) |
Approval |
| 12/08/2015 |
TAMSULOSIN HYDROCHLORIDE
ANDA #077630 |
SUPPL-6 |
TAMSULOSIN HYDROCHLORIDE |
TEVA PHARMS |
Labeling |
Approval |
| 12/08/2015 |
TAMSULOSIN HYDROCHLORIDE
ANDA #077630 |
SUPPL-7 |
TAMSULOSIN HYDROCHLORIDE |
TEVA PHARMS |
Labeling |
Approval |
| 12/08/2015 |
KANUMA
BLA #125561 |
ORIG-1 |
SEBELIPASE ALFA |
ALEXION PHARM |
|
Approval |
| 12/08/2015 |
MONTELUKAST SODIUM
ANDA #202096 |
SUPPL-10 |
MONTELUKAST SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/08/2015 |
MONTELUKAST SODIUM
ANDA #202096 |
SUPPL-13 |
MONTELUKAST SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/08/2015 |
MONTELUKAST SODIUM
ANDA #202468 |
SUPPL-11 |
MONTELUKAST SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/08/2015 |
MONTELUKAST SODIUM
ANDA #202468 |
SUPPL-14 |
MONTELUKAST SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 12/08/2015 |
MONTELUKAST SODIUM
ANDA #202859 |
SUPPL-5 |
MONTELUKAST SODIUM |
UNIMARK REMEDIES LTD |
Labeling |
Approval |
| 12/08/2015 |
MONTELUKAST SODIUM
ANDA #203037 |
SUPPL-5 |
MONTELUKAST SODIUM |
UNIMARK REMEDIES LTD |
Labeling |
Approval |
| 12/08/2015 |
POTASSIUM CHLORIDE
ANDA #205549 |
ORIG-1 |
POTASSIUM CHLORIDE |
STRIDES PHARMA |
|
Approval |
| 12/08/2015 |
EPTIFIBATIDE
ANDA #206127 |
ORIG-1 |
EPTIFIBATIDE |
EUGIA PHARMA |
|
Approval |
| 12/08/2015 |
ATHENTIA NEXT
ANDA #206867 |
ORIG-1 |
LEVONORGESTREL |
AUROBINDO PHARMA |
|
Approval |
| 12/09/2015 |
HIBICLENS
NDA #017768 |
SUPPL-42 |
CHLORHEXIDINE GLUCONATE |
MOLNLYCKE HLTH |
Manufacturing (CMC) |
Approval |
| 12/09/2015 |
AZILECT
NDA #021641 |
SUPPL-19 |
RASAGILINE MESYLATE |
TEVA |
Manufacturing (CMC) |
Approval |
| 12/09/2015 |
CLARITIN
NDA #021952 |
SUPPL-12 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
| 12/09/2015 |
CEFOTAN
NDA #050588 |
SUPPL-31 |
CEFOTETAN DISODIUM |
PAI HOLDINGS PHARM |
Manufacturing (CMC) |
Approval |
| 12/09/2015 |
CARISOPRODOL AND ASPIRIN
ANDA #089594 |
SUPPL-8 |
ASPIRIN; CARISOPRODOL |
CHARTWELL RX |
Manufacturing (CMC) |
Approval |
| 12/09/2015 |
METRONIDAZOLE
ANDA #090903 |
SUPPL-2 |
METRONIDAZOLE |
CHARTWELL RX |
Manufacturing (CMC) |
Approval |
| 12/09/2015 |
VARDENAFIL HYDROCHLORIDE
ANDA #091347 |
SUPPL-2 |
VARDENAFIL HYDROCHLORIDE |
TEVA PHARMS |
Labeling |
Approval |
| 12/09/2015 |
LATANOPROST
ANDA #201006 |
SUPPL-6 |
LATANOPROST |
BAUSCH AND LOMB |
Labeling |
Approval |
| 12/09/2015 |
RISEDRONATE SODIUM
ANDA #203533 |
ORIG-1 |
RISEDRONATE SODIUM |
MACLEODS PHARMS LTD |
|
Approval |
| 12/09/2015 |
SIRTURO
NDA #204384 |
SUPPL-6 |
BEDAQUILINE FUMARATE |
JANSSEN THERAP |
Labeling |
Approval |
| 12/09/2015 |
AMIKACIN SULFATE
ANDA #205604 |
ORIG-1 |
AMIKACIN SULFATE |
FRESENIUS KABI USA |
|
Approval |
| 12/09/2015 |
AMIKACIN SULFATE
ANDA #205605 |
ORIG-1 |
AMIKACIN SULFATE |
FRESENIUS KABI USA |
|
Approval |
| 12/09/2015 |
DICLOFENAC SODIUM
ANDA #205878 |
ORIG-1 |
DICLOFENAC SODIUM |
NOVEL LABS INC |
|
Approval |
| 12/09/2015 |
CYCLOPENTOLATE HYDROCHLORIDE
ANDA #205937 |
ORIG-1 |
CYCLOPENTOLATE HYDROCHLORIDE |
SCIEGEN PHARMS INC |
|
Approval |
| 12/10/2015 |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #017427 |
SUPPL-75 |
SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 12/10/2015 |
CLARITIN
NDA #020641 |
SUPPL-39 |
LORATADINE |
BAYER HEALTHCARE LLC |
Manufacturing (CMC) |
Approval |
| 12/10/2015 |
CLARITIN HIVES RELIEF
NDA #020641 |
SUPPL-39 |
LORATADINE |
BAYER HEALTHCARE LLC |
Manufacturing (CMC) |
Approval |
| 12/10/2015 |
GLUCAGEN
NDA #020918 |
SUPPL-43 |
GLUCAGON HYDROCHLORIDE |
NOVO NORDISK |
Labeling |
Approval |
| 12/10/2015 |
SPIRIVA
NDA #021395 |
SUPPL-40 |
TIOTROPIUM BROMIDE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 12/10/2015 |
CIPRODEX
NDA #021537 |
SUPPL-12 |
CIPROFLOXACIN; DEXAMETHASONE |
SANDOZ |
Labeling |
Approval |
| 12/10/2015 |
CAMBIA
NDA #022165 |
SUPPL-9 |
DICLOFENAC POTASSIUM |
ASSERTIO |
Manufacturing (CMC) |
Approval |
| 12/10/2015 |
SUMATRIPTAN SUCCINATE
ANDA #078319 |
ORIG-1 |
SUMATRIPTAN SUCCINATE |
ANTARES PHARMA INC |
|
Approval |
| 12/10/2015 |
ZYTIGA
NDA #202379 |
SUPPL-21 |
ABIRATERONE ACETATE |
JANSSEN BIOTECH |
Labeling |
Approval |
| 12/10/2015 |
IRBESARTAN
ANDA #203685 |
ORIG-1 |
IRBESARTAN |
AJANTA PHARMA LTD |
|
Approval |
| 12/10/2015 |
FYAVOLV
ANDA #204213 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
LUPIN LTD |
|
Approval |
| 12/10/2015 |
FESOTERODINE FUMARATE
ANDA #204827 |
ORIG-1 |
FESOTERODINE FUMARATE |
ALKEM LABS LTD |
|
Approval |
| 12/10/2015 |
AMLODIPINE BESYLATE
ANDA #206367 |
ORIG-1 |
AMLODIPINE BESYLATE |
INVAGEN PHARMS |
|
Approval |
| 12/10/2015 |
OTIPRIO
NDA #207986 |
ORIG-1 |
CIPROFLOXACIN |
ALK ABELLO |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 12/11/2015 |
COZAAR
NDA #020386 |
SUPPL-54 |
LOSARTAN POTASSIUM |
ORGANON |
Labeling |
Approval |
| 12/11/2015 |
HYZAAR
NDA #020387 |
SUPPL-47 |
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM |
ORGANON |
Labeling |
Approval |
| 12/11/2015 |
TAXOTERE
NDA #020449 |
SUPPL-75 |
DOCETAXEL |
SANOFI AVENTIS US |
Labeling |
Approval |
| 12/11/2015 |
ATNAA
NDA #021175 |
SUPPL-29 |
ATROPINE; PRALIDOXIME CHLORIDE |
US ARMY |
Manufacturing (CMC) |
Approval |
| 12/11/2015 |
ZANTAC 150
NDA #021698 |
SUPPL-19 |
RANITIDINE HYDROCHLORIDE |
CHATTEM SANOFI |
Labeling |
Approval |
| 12/11/2015 |
LOPERAMIDE HYDROCHLORIDE
NDA #021855 |
SUPPL-5 |
LOPERAMIDE HYDROCHLORIDE |
BIONPHARMA |
Manufacturing (CMC) |
Approval |
| 12/11/2015 |
DUODOTE
NDA #021983 |
SUPPL-19 |
ATROPINE; PRALIDOXIME CHLORIDE |
MMT |
Manufacturing (CMC) |
Approval |
| 12/11/2015 |
TYZEKA
NDA #022011 |
SUPPL-17 |
TELBIVUDINE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
| 12/11/2015 |
SOMATULINE DEPOT
NDA #022074 |
SUPPL-15 |
LANREOTIDE ACETATE |
IPSEN PHARMA |
Manufacturing (CMC) |
Approval |
| 12/11/2015 |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #062373 |
SUPPL-39 |
GENTAMICIN SULFATE |
BAXTER HLTHCARE |
Labeling |
Approval |
| 12/11/2015 |
CLARITHROMYCIN
ANDA #065195 |
SUPPL-7 |
CLARITHROMYCIN |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
| 12/11/2015 |
CLARITHROMYCIN
ANDA #065195 |
SUPPL-13 |
CLARITHROMYCIN |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
| 12/11/2015 |
KETOROLAC TROMETHAMINE
ANDA #076109 |
SUPPL-5 |
KETOROLAC TROMETHAMINE |
APOTEX INC |
Labeling |
Approval |
| 12/11/2015 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #076116 |
SUPPL-8 |
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE |
CHARTWELL RX |
Labeling |
Approval |
| 12/11/2015 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #076116 |
SUPPL-9 |
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE |
CHARTWELL RX |
Labeling |
Approval |
| 12/11/2015 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #076116 |
SUPPL-10 |
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE |
CHARTWELL RX |
Labeling |
Approval |
| 12/11/2015 |
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
ANDA #076116 |
SUPPL-11 |
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE |
CHARTWELL RX |
Labeling |
Approval |
| 12/11/2015 |
ZIDOVUDINE
ANDA #077268 |
SUPPL-12 |
ZIDOVUDINE |
AUROBINDO |
Manufacturing (CMC) |
Approval |
| 12/11/2015 |
KETOROLAC TROMETHAMINE
ANDA #077308 |
SUPPL-5 |
KETOROLAC TROMETHAMINE |
APOTEX INC |
Labeling |
Approval |
| 12/11/2015 |
LAMOTRIGINE
ANDA #077633 |
SUPPL-17 |
LAMOTRIGINE |
ZYDUS PHARMS USA |
Labeling |
Approval |
| 12/11/2015 |
LAMOTRIGINE
ANDA #077633 |
SUPPL-18 |
LAMOTRIGINE |
ZYDUS PHARMS USA |
Labeling |
Approval |
| 12/11/2015 |
LAMOTRIGINE
ANDA #077633 |
SUPPL-20 |
LAMOTRIGINE |
ZYDUS PHARMS USA |
Labeling |
Approval |
| 12/11/2015 |
LAMOTRIGINE
ANDA #077633 |
SUPPL-24 |
LAMOTRIGINE |
ZYDUS PHARMS USA |
Labeling |
Approval |
| 12/11/2015 |
LAMOTRIGINE
ANDA #078009 |
SUPPL-16 |
LAMOTRIGINE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 12/11/2015 |
LAMOTRIGINE
ANDA #078009 |
SUPPL-17 |
LAMOTRIGINE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 12/11/2015 |
LAMOTRIGINE
ANDA #078009 |
SUPPL-18 |
LAMOTRIGINE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 12/11/2015 |
LAMOTRIGINE
ANDA #078009 |
SUPPL-19 |
LAMOTRIGINE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
| 12/11/2015 |
ROPINIROLE HYDROCHLORIDE
ANDA #078110 |
SUPPL-6 |
ROPINIROLE HYDROCHLORIDE |
PRINSTON INC |
Labeling |
Approval |
| 12/11/2015 |
ROPINIROLE HYDROCHLORIDE
ANDA #078110 |
SUPPL-11 |
ROPINIROLE HYDROCHLORIDE |
PRINSTON INC |
Manufacturing (CMC) |
Approval |
| 12/11/2015 |
OXALIPLATIN
ANDA #078817 |
SUPPL-7 |
OXALIPLATIN |
SANDOZ |
Labeling |
Approval |
| 12/11/2015 |
OXALIPLATIN
ANDA #078817 |
SUPPL-8 |
OXALIPLATIN |
SANDOZ |
Labeling |
Approval |
| 12/11/2015 |
OXALIPLATIN
ANDA #078817 |
SUPPL-16 |
OXALIPLATIN |
SANDOZ |
Labeling |
Approval |
| 12/11/2015 |
CARISOPRODOL AND ASPIRIN
ANDA #089594 |
SUPPL-9 |
ASPIRIN; CARISOPRODOL |
CHARTWELL RX |
Labeling |
Approval |
| 12/11/2015 |
DOXYCYCLINE HYCLATE
ANDA #090431 |
SUPPL-9 |
DOXYCYCLINE HYCLATE |
RISING |
Labeling |
Approval |
| 12/11/2015 |
ABACAVIR SULFATE
ANDA #091294 |
SUPPL-1 |
ABACAVIR SULFATE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 12/11/2015 |
ABACAVIR SULFATE
ANDA #091294 |
SUPPL-3 |
ABACAVIR SULFATE |
MYLAN PHARMS INC |
Manufacturing (CMC) |
Approval |
| 12/11/2015 |
ABACAVIR SULFATE
ANDA #091294 |
SUPPL-4 |
ABACAVIR SULFATE |
MYLAN PHARMS INC |
Labeling |
Approval |
| 12/11/2015 |
VALSARTAN
ANDA #091367 |
SUPPL-2 |
VALSARTAN |
ALEMBIC |
Manufacturing (CMC) |
Approval |
| 12/11/2015 |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #200435 |
SUPPL-4 |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TEVA PHARMS |
Labeling |
Approval |
| 12/11/2015 |
RANITIDINE HYDROCHLORIDE
ANDA #200536 |
SUPPL-6 |
RANITIDINE HYDROCHLORIDE |
STRIDES PHARMA |
Labeling |
Approval |
| 12/11/2015 |
TOPOTECAN HYDROCHLORIDE
ANDA #201191 |
SUPPL-2 |
TOPOTECAN HYDROCHLORIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 12/11/2015 |
TOPOTECAN HYDROCHLORIDE
ANDA #201191 |
SUPPL-3 |
TOPOTECAN HYDROCHLORIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 12/11/2015 |
ARGATROBAN
NDA #201811 |
SUPPL-1 |
ARGATROBAN |
FRESENIUS KABI USA |
Labeling |
Approval |
| 12/11/2015 |
CLOPIDOGREL BISULFATE
ANDA #202266 |
SUPPL-2 |
CLOPIDOGREL BISULFATE |
CHARTWELL RX |
Labeling |
Approval |
| 12/11/2015 |
CLOPIDOGREL BISULFATE
ANDA #202266 |
SUPPL-4 |
CLOPIDOGREL BISULFATE |
CHARTWELL RX |
Labeling |
Approval |
| 12/11/2015 |
OXACILLIN SODIUM
ANDA #203950 |
ORIG-1 |
OXACILLIN SODIUM |
HOSPIRA |
|
Approval |
| 12/11/2015 |
NIACIN
ANDA #204178 |
ORIG-1 |
NIACIN |
AMNEAL PHARMS |
|
Approval |
| 12/11/2015 |
NATEGLINIDE
ANDA #205055 |
ORIG-1 |
NATEGLINIDE |
ALVOGEN |
|
Approval |
| 12/11/2015 |
PROAIR DIGIHALER
NDA #205636 |
SUPPL-3 |
ALBUTEROL SULFATE |
TEVA BRANDED PHARM |
Manufacturing (CMC) |
Approval |
| 12/11/2015 |
PROAIR RESPICLICK
NDA #205636 |
SUPPL-3 |
ALBUTEROL SULFATE |
TEVA BRANDED PHARM |
Manufacturing (CMC) |
Approval |
| 12/11/2015 |
CYANOCOBALAMIN
ANDA #206503 |
ORIG-1 |
CYANOCOBALAMIN |
SOMERSET THERAPS LLC |
|
Approval |
| 12/11/2015 |
VISTOGARD
NDA #208159 |
ORIG-1 |
URIDINE TRIACETATE |
BTG INTL |
Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated |
Approval |
| 12/11/2015 |
ALECENSA
NDA #208434 |
ORIG-1 |
ALECTINIB HYDROCHLORIDE |
HOFFMANN-LA ROCHE |
Type 1 - New Molecular Entity |
Approval |
| 12/14/2015 |
EXPAREL
NDA #022496 |
SUPPL-19 |
BUPIVACAINE |
PACIRA PHARMS INC |
Labeling |
Approval |
| 12/14/2015 |
BACTROBAN
NDA #050591 |
SUPPL-33 |
MUPIROCIN |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 12/14/2015 |
BACTROBAN
NDA #050746 |
SUPPL-20 |
MUPIROCIN CALCIUM |
GLAXOSMITHKLINE |
Labeling |
Approval |
| 12/14/2015 |
FYCOMPA
NDA #202834 |
SUPPL-7 |
PERAMPANEL |
CATALYST PHARMS |
Manufacturing (CMC) |
Approval |
| 12/14/2015 |
RYTARY
NDA #203312 |
SUPPL-1 |
CARBIDOPA; LEVODOPA |
IMPAX |
Manufacturing (CMC) |
Approval |
| 12/14/2015 |
RYTARY
NDA #203312 |
SUPPL-2 |
CARBIDOPA; LEVODOPA |
IMPAX |
Manufacturing (CMC) |
Approval |
| 12/14/2015 |
KERYDIN
NDA #204427 |
SUPPL-5 |
TAVABOROLE |
ANACOR PHARMS INC |
Manufacturing (CMC) |
Approval |
| 12/14/2015 |
SPRITAM
NDA #207958 |
SUPPL-1 |
LEVETIRACETAM |
APRECIA PHARMS |
Manufacturing (CMC) |
Approval |
| 12/15/2015 |
HALCION
NDA #017892 |
SUPPL-48 |
TRIAZOLAM |
PFIZER |
Manufacturing (CMC) |
Approval |
| 12/15/2015 |
HECTOROL
NDA #021027 |
SUPPL-31 |
DOXERCALCIFEROL |
SANOFI |
Manufacturing (CMC) |
Approval |
| 12/15/2015 |
RAZADYNE
NDA #021169 |
SUPPL-31 |
GALANTAMINE HYDROBROMIDE |
JANSSEN PHARMS |
Labeling |
Approval |
| 12/15/2015 |
RAZADYNE
NDA #021224 |
SUPPL-29 |
GALANTAMINE HYDROBROMIDE |
JANSSEN PHARMS |
Labeling |
Approval |
| 12/15/2015 |
RANEXA
NDA #021526 |
SUPPL-28 |
RANOLAZINE |
MENARINI INTL |
Labeling |
Approval |
| 12/15/2015 |
RAZADYNE ER
NDA #021615 |
SUPPL-22 |
GALANTAMINE HYDROBROMIDE |
JANSSEN PHARMS |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL BGK 4/0 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL BK 0/0 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER
NDA #021703 |
SUPPL-16 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
BRIDION
NDA #022225 |
ORIG-1 |
SUGAMMADEX SODIUM |
MSD SUB MERCK |
Type 1 - New Molecular Entity |
Approval |
| 12/15/2015 |
TOPIRAMATE
ANDA #076314 |
SUPPL-12 |
TOPIRAMATE |
NATCO |
Labeling |
Approval |
| 12/15/2015 |
TOPIRAMATE
ANDA #076314 |
SUPPL-13 |
TOPIRAMATE |
NATCO |
Labeling |
Approval |
| 12/15/2015 |
TOPIRAMATE
ANDA #076314 |
SUPPL-14 |
TOPIRAMATE |
NATCO |
Labeling |
Approval |
| 12/15/2015 |
BENZPHETAMINE HYDROCHLORIDE
ANDA #090346 |
ORIG-1 |
BENZPHETAMINE HYDROCHLORIDE |
EPIC PHARMA LLC |
|
Approval |
| 12/15/2015 |
TACROLIMUS
ANDA #090596 |
SUPPL-6 |
TACROLIMUS |
MYLAN |
Labeling |
Approval |
| 12/15/2015 |
RISEDRONATE SODIUM
ANDA #090877 |
SUPPL-1 |
RISEDRONATE SODIUM |
APOTEX |
Labeling |
Approval |
| 12/15/2015 |
CITALOPRAM HYDROBROMIDE
ANDA #201450 |
ORIG-1 |
CITALOPRAM HYDROBROMIDE |
HETERO LABS LTD III |
|
Approval |
| 12/15/2015 |
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
NDA #202106 |
SUPPL-1 |
MEROPENEM |
B BRAUN MEDICAL INC |
Manufacturing (CMC) |
Approval |
| 12/15/2015 |
POLYETHYLENE GLYCOL 3350
ANDA #202850 |
ORIG-1 |
POLYETHYLENE GLYCOL 3350 |
ANI PHARMS |
|
Approval |
| 12/15/2015 |
LOPERAMIDE HYDROCHLORIDE
ANDA #206548 |
ORIG-1 |
LOPERAMIDE HYDROCHLORIDE |
AUROBINDO PHARMA |
|
Approval |
| 12/15/2015 |
PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER
NDA #207026 |
SUPPL-1 |
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER
NDA #207026 |
SUPPL-1 |
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/15/2015 |
METHYLPREDNISOLONE SODIUM SUCCINATE
ANDA #207667 |
ORIG-1 |
METHYLPREDNISOLONE SODIUM SUCCINATE |
EUGIA PHARMA |
|
Approval |
| 12/16/2015 |
ADVIL
NDA #018989 |
SUPPL-84 |
IBUPROFEN |
HALEON US HOLDINGS |
Manufacturing (CMC) |
Approval |
| 12/16/2015 |
BETAGAN
NDA #019219 |
SUPPL-28 |
LEVOBUNOLOL HYDROCHLORIDE |
ALLERGAN |
Manufacturing (CMC) |
Approval |
| 12/16/2015 |
RENACIDIN
NDA #019481 |
SUPPL-12 |
CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE |
UNITED GUARDIAN |
Manufacturing (CMC) |
Approval |
| 12/16/2015 |
PREVACID
NDA #020406 |
SUPPL-80 |
LANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 12/16/2015 |
INVIRASE
NDA #020628 |
SUPPL-43 |
SAQUINAVIR MESYLATE |
HOFFMANN LA ROCHE |
Labeling |
Approval |
| 12/16/2015 |
QVAR 40
NDA #020911 |
SUPPL-27 |
BECLOMETHASONE DIPROPIONATE |
TEVA BRANDED PHARM |
Manufacturing (CMC) |
Approval |
| 12/16/2015 |
QVAR 80
NDA #020911 |
SUPPL-27 |
BECLOMETHASONE DIPROPIONATE |
TEVA BRANDED PHARM |
Manufacturing (CMC) |
Approval |
| 12/16/2015 |
AVANDIA
NDA #021071 |
SUPPL-50 |
ROSIGLITAZONE MALEATE |
WOODWARD |
REMS |
Approval |
| 12/16/2015 |
AVANDAMET
NDA #021410 |
SUPPL-39 |
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE |
SB PHARMCO |
REMS |
Approval |
| 12/16/2015 |
PREVACID
NDA #021428 |
SUPPL-27 |
LANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 12/16/2015 |
CLOLAR
NDA #021673 |
SUPPL-24 |
CLOFARABINE |
GENZYME |
Labeling |
Approval |
| 12/16/2015 |
AVANDARYL
NDA #021700 |
SUPPL-22 |
GLIMEPIRIDE; ROSIGLITAZONE MALEATE |
SB PHARMCO |
REMS |
Approval |
| 12/16/2015 |
INVIRASE
NDA #021785 |
SUPPL-19 |
SAQUINAVIR MESYLATE |
HOFFMANN-LA ROCHE |
Labeling |
Approval |
| 12/16/2015 |
ZIPSOR
NDA #022202 |
SUPPL-10 |
DICLOFENAC POTASSIUM |
ASSERTIO |
Labeling |
Approval |
| 12/16/2015 |
DEXILANT
NDA #022287 |
SUPPL-18 |
DEXLANSOPRAZOLE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 12/16/2015 |
VIIBRYD
NDA #022567 |
SUPPL-16 |
VILAZODONE HYDROCHLORIDE |
ABBVIE |
Manufacturing (CMC) |
Approval |
| 12/16/2015 |
BACTROBAN
NDA #050746 |
SUPPL-19 |
MUPIROCIN CALCIUM |
GLAXOSMITHKLINE |
Manufacturing (CMC) |
Approval |
| 12/16/2015 |
PENICILLIN G PROCAINE
ANDA #060101 |
SUPPL-34 |
PENICILLIN G PROCAINE |
KING PHARMS LLC |
Labeling |
Approval |
| 12/16/2015 |
PENICILLIN G PROCAINE
ANDA #060101 |
SUPPL-36 |
PENICILLIN G PROCAINE |
KING PHARMS LLC |
Labeling |
Approval |
| 12/16/2015 |
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL
ANDA #062759 |
SUPPL-35 |
ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL |
BARR |
Labeling |
Approval |
| 12/16/2015 |
CLARITHROMYCIN
ANDA #065154 |
SUPPL-11 |
CLARITHROMYCIN |
DR REDDYS LABS SA |
Labeling |
Approval |
| 12/16/2015 |
CLARITHROMYCIN
ANDA #065154 |
SUPPL-12 |
CLARITHROMYCIN |
DR REDDYS LABS SA |
Labeling |
Approval |
| 12/16/2015 |
CLARITHROMYCIN
ANDA #065154 |
SUPPL-13 |
CLARITHROMYCIN |
DR REDDYS LABS SA |
Labeling |
Approval |
| 12/16/2015 |
CLARITHROMYCIN
ANDA #065154 |
SUPPL-14 |
CLARITHROMYCIN |
DR REDDYS LABS SA |
Labeling |
Approval |
| 12/16/2015 |
AMNESTEEM
ANDA #075945 |
SUPPL-27 |
ISOTRETINOIN |
MYLAN PHARMS INC |
Labeling |
Approval |
| 12/16/2015 |
AMNESTEEM
ANDA #075945 |
SUPPL-28 |
ISOTRETINOIN |
MYLAN PHARMS INC |
Manufacturing (CMC) |
Approval |
| 12/16/2015 |
SIMVASTATIN
ANDA #076052 |
SUPPL-40 |
SIMVASTATIN |
IVAX SUB TEVA PHARMS |
Labeling |
Approval |
| 12/16/2015 |
FLUTICASONE PROPIONATE
ANDA #077570 |
SUPPL-10 |
FLUTICASONE PROPIONATE |
HIKMA |
Manufacturing (CMC) |
Approval |
| 12/16/2015 |
METOPROLOL SUCCINATE
ANDA #090617 |
SUPPL-5 |
METOPROLOL SUCCINATE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 12/16/2015 |
ETHINYL ESTRADIOL AND LEVONORGESTREL
ANDA #091690 |
ORIG-1 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
NOVAST LABS |
|
Tentative Approval |
| 12/16/2015 |
BUSPIRONE HYDROCHLORIDE
ANDA #202087 |
ORIG-1 |
BUSPIRONE HYDROCHLORIDE |
AIPING PHARM INC |
|
Approval |
| 12/16/2015 |
TOPOTECAN HYDROCHLORIDE
ANDA #202203 |
SUPPL-1 |
TOPOTECAN HYDROCHLORIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 12/16/2015 |
TOPOTECAN HYDROCHLORIDE
ANDA #202203 |
SUPPL-2 |
TOPOTECAN HYDROCHLORIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 12/16/2015 |
CYCLAFEM 0.5/35
ANDA #203413 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE |
ENDO OPERATIONS |
|
Approval |
| 12/16/2015 |
MORPHINE SULFATE
ANDA #203602 |
ORIG-1 |
MORPHINE SULFATE |
NOVEL LABS INC |
|
Approval |
| 12/16/2015 |
ASTAGRAF XL
NDA #204096 |
SUPPL-3 |
TACROLIMUS |
ASTELLAS |
Labeling |
Approval |
| 12/16/2015 |
ASTAGRAF XL
NDA #204096 |
SUPPL-4 |
TACROLIMUS |
ASTELLAS |
Labeling |
Approval |
| 12/16/2015 |
TOPICORT
NDA #204141 |
SUPPL-4 |
DESOXIMETASONE |
TARO |
Labeling |
Approval |
| 12/16/2015 |
LEVETIRACETAM
ANDA #205102 |
ORIG-1 |
LEVETIRACETAM |
SECAN PHARMS |
|
Approval |
| 12/16/2015 |
LEVETIRACETAM
ANDA #205102 |
ORIG-2 |
LEVETIRACETAM |
SECAN PHARMS |
|
Approval |
| 12/16/2015 |
LEVETIRACETAM
ANDA #205102 |
ORIG-3 |
LEVETIRACETAM |
SECAN PHARMS |
|
Tentative Approval |
| 12/16/2015 |
BASAGLAR
BLA #205692 |
ORIG-1 |
INSULIN GLARGINE |
ELI LILLY AND CO |
|
Approval |
| 12/17/2015 |
RETIN-A
NDA #017340 |
SUPPL-47 |
TRETINOIN |
VALEANT PHARMS NORTH |
Manufacturing (CMC) |
Approval |
| 12/17/2015 |
LOTENSIN
NDA #019851 |
SUPPL-50 |
BENAZEPRIL HYDROCHLORIDE |
VALIDUS PHARMS |
Manufacturing (CMC) |
Approval |
| 12/17/2015 |
CORLOPAM
NDA #019922 |
SUPPL-16 |
FENOLDOPAM MESYLATE |
HOSPIRA |
Labeling |
Approval |
| 12/17/2015 |
CAPEX
NDA #020001 |
SUPPL-12 |
FLUOCINOLONE ACETONIDE |
GALDERMA LABS LP |
Labeling |
Approval |
| 12/17/2015 |
ADVIL LIQUI-GELS
NDA #020402 |
SUPPL-40 |
IBUPROFEN |
HALEON US HOLDINGS |
Manufacturing (CMC) |
Approval |
| 12/17/2015 |
ADVIL MIGRAINE LIQUI-GELS
NDA #020402 |
SUPPL-40 |
IBUPROFEN |
HALEON US HOLDINGS |
Manufacturing (CMC) |
Approval |
| 12/17/2015 |
ELLIOTTS B SOLUTION
NDA #020577 |
SUPPL-9 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE |
LUKARE MEDICAL LLC |
Manufacturing (CMC) |
Approval |
| 12/17/2015 |
ZOLINZA
NDA #021991 |
SUPPL-8 |
VORINOSTAT |
MSD SUB MERCK |
Labeling |
Approval |
| 12/17/2015 |
COLCRYS
NDA #022352 |
SUPPL-22 |
COLCHICINE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 12/17/2015 |
VIDAZA
NDA #050794 |
SUPPL-28 |
AZACITIDINE |
BRISTOL-MYERS |
Labeling |
Approval |
| 12/17/2015 |
SULINDAC
ANDA #071795 |
SUPPL-41 |
SULINDAC |
WATSON LABS |
Labeling |
Approval |
| 12/17/2015 |
ETODOLAC
ANDA #074932 |
SUPPL-6 |
ETODOLAC |
NATCO PHARMA |
Labeling |
Approval |
| 12/17/2015 |
FLUOXETINE HYDROCHLORIDE
ANDA #076922 |
SUPPL-10 |
FLUOXETINE HYDROCHLORIDE |
STRIDES PHARMA |
Labeling |
Approval |
| 12/17/2015 |
VALSARTAN
ANDA #077492 |
SUPPL-1 |
VALSARTAN |
OHM LABS INC |
Labeling |
Approval |
| 12/17/2015 |
VALSARTAN
ANDA #077492 |
SUPPL-3 |
VALSARTAN |
OHM LABS INC |
Labeling |
Approval |
| 12/17/2015 |
LATANOPROST
ANDA #077697 |
SUPPL-6 |
LATANOPROST |
APOTEX INC |
Labeling |
Approval |
| 12/17/2015 |
SERTRALINE HYDROCHLORIDE
ANDA #077765 |
SUPPL-15 |
SERTRALINE HYDROCHLORIDE |
TORRENT PHARMS |
Labeling |
Approval |
| 12/17/2015 |
SERTRALINE HYDROCHLORIDE
ANDA #077765 |
SUPPL-16 |
SERTRALINE HYDROCHLORIDE |
TORRENT PHARMS |
Labeling |
Approval |
| 12/17/2015 |
CEFADROXIL
ANDA #091036 |
SUPPL-4 |
CEFADROXIL/CEFADROXIL HEMIHYDRATE |
HIKMA PHARMS |
Labeling |
Approval |
| 12/17/2015 |
CEFADROXIL
ANDA #091036 |
SUPPL-5 |
CEFADROXIL/CEFADROXIL HEMIHYDRATE |
HIKMA PHARMS |
Labeling |
Approval |
| 12/17/2015 |
SILDENAFIL CITRATE
ANDA #091479 |
SUPPL-7 |
SILDENAFIL CITRATE |
TORRENT PHARMS LTD |
Labeling |
Approval |
| 12/17/2015 |
QUININE SULFATE
ANDA #091661 |
SUPPL-4 |
QUININE SULFATE |
TEVA PHARMS |
Labeling |
Approval |
| 12/17/2015 |
RASAGILINE MESYLATE
ANDA #201950 |
SUPPL-1 |
RASAGILINE MESYLATE |
APOTEX INC |
Labeling |
Approval |
| 12/17/2015 |
LATANOPROST
ANDA #202077 |
SUPPL-1 |
LATANOPROST |
RYAN LABS |
Labeling |
Approval |
| 12/17/2015 |
DONEPEZIL HYDROCHLORIDE
ANDA #202415 |
ORIG-1 |
DONEPEZIL HYDROCHLORIDE |
ACTAVIS ELIZABETH |
|
Approval |
| 12/17/2015 |
KAITLIB FE
ANDA #203448 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE |
LUPIN LTD |
|
Approval |
| 12/17/2015 |
AMMONIA N 13
ANDA #205687 |
ORIG-1 |
AMMONIA N-13 |
ESSENTIAL ISOTOPES |
|
Approval |
| 12/17/2015 |
PERPHENAZINE
ANDA #205973 |
ORIG-1 |
PERPHENAZINE |
WILSHIRE PHARMS INC |
|
Approval |
| 12/17/2015 |
IBRANCE
NDA #207103 |
SUPPL-1 |
PALBOCICLIB |
PFIZER |
Manufacturing (CMC) |
Approval |
| 12/17/2015 |
EMEND
NDA #207865 |
ORIG-1 |
APREPITANT |
MSD MERCK CO |
Type 3 - New Dosage Form |
Approval |
| 12/18/2015 |
CLARITIN
NDA #019658 |
SUPPL-44 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
| 12/18/2015 |
CLARITIN HIVES RELIEF
NDA #019658 |
SUPPL-44 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
| 12/18/2015 |
GLUCAGON
NDA #020928 |
SUPPL-51 |
GLUCAGON |
LILLY |
Manufacturing (CMC) |
Approval |
| 12/18/2015 |
LOTRIMIN ULTRA
NDA #021307 |
SUPPL-15 |
BUTENAFINE HYDROCHLORIDE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
| 12/18/2015 |
ENABLEX
NDA #021513 |
SUPPL-14 |
DARIFENACIN HYDROBROMIDE |
ABBVIE |
Manufacturing (CMC) |
Approval |
| 12/18/2015 |
DALVANCE
NDA #021883 |
SUPPL-2 |
DALBAVANCIN HYDROCHLORIDE |
ABBVIE |
Labeling |
Approval |
| 12/18/2015 |
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
NDA #050671 |
SUPPL-22 |
VANCOMYCIN HYDROCHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 12/18/2015 |
ZOSYN
NDA #050684 |
SUPPL-83 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
WYETH PHARMS |
Labeling |
Approval |
| 12/18/2015 |
ZOSYN IN PLASTIC CONTAINER
NDA #050750 |
SUPPL-33 |
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
| 12/18/2015 |
SOTALOL HYDROCHLORIDE
ANDA #075366 |
SUPPL-16 |
SOTALOL HYDROCHLORIDE |
UPSHER SMITH LABS |
Manufacturing (CMC) |
Approval |
| 12/18/2015 |
SOTALOL HYDROCHLORIDE
ANDA #075366 |
SUPPL-19 |
SOTALOL HYDROCHLORIDE |
UPSHER SMITH LABS |
Labeling |
Approval |
| 12/18/2015 |
KEYTRUDA
BLA #125514 |
SUPPL-4 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 12/18/2015 |
KEYTRUDA
BLA #125514 |
SUPPL-6 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
| 12/18/2015 |
POTASSIUM CHLORIDE
ANDA #203002 |
ORIG-1 |
POTASSIUM CHLORIDE |
LUPIN LTD |
|
Approval |
| 12/18/2015 |
NADOLOL
ANDA #203455 |
ORIG-1 |
NADOLOL |
INVAGEN PHARMS |
|
Approval |
| 12/18/2015 |
ZOLMITRIPTAN
ANDA #204284 |
SUPPL-1 |
ZOLMITRIPTAN |
INVAGEN PHARMS |
Manufacturing (CMC) |
Approval |
| 12/18/2015 |
OLOPATADINE HYDROCHLORIDE
ANDA #204812 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
EUGIA PHARMA |
|
Approval |
| 12/18/2015 |
MEROPENEM
ANDA #204854 |
ORIG-1 |
MEROPENEM |
DAEWOONG PHARM CO |
|
Approval |
| 12/20/2015 |
DOXYCYCLINE
ANDA #065070 |
SUPPL-17 |
DOXYCYCLINE |
STRIDES PHARMA |
Labeling |
Approval |
| 12/20/2015 |
DOXYCYCLINE
ANDA #065070 |
SUPPL-21 |
DOXYCYCLINE |
STRIDES PHARMA |
Labeling |
Approval |
| 12/21/2015 |
INDERAL LA
NDA #018553 |
SUPPL-39 |
PROPRANOLOL HYDROCHLORIDE |
ANI PHARMS |
Manufacturing (CMC) |
Approval |
| 12/21/2015 |
CARDENE
NDA #019734 |
SUPPL-26 |
NICARDIPINE HYDROCHLORIDE |
CHIESI |
Manufacturing (CMC) |
Approval |
| 12/21/2015 |
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734 |
SUPPL-26 |
NICARDIPINE HYDROCHLORIDE |
CHIESI |
Manufacturing (CMC) |
Approval |
| 12/21/2015 |
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
NDA #019734 |
SUPPL-26 |
NICARDIPINE HYDROCHLORIDE |
CHIESI |
Manufacturing (CMC) |
Approval |
| 12/21/2015 |
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
NDA #019734 |
SUPPL-26 |
NICARDIPINE HYDROCHLORIDE |
CHIESI |
Manufacturing (CMC) |
Approval |
| 12/21/2015 |
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
NDA #019734 |
SUPPL-26 |
NICARDIPINE HYDROCHLORIDE |
CHIESI |
Manufacturing (CMC) |
Approval |
| 12/21/2015 |
ADAGEN
BLA #019818 |
SUPPL-56 |
PEGADEMASE BOVINE |
LEADIANT BIOSCI INC |
|
Approval |
| 12/21/2015 |
COLGATE TOTAL
NDA #020231 |
SUPPL-74 |
SODIUM FLUORIDE; TRICLOSAN |
COLGATE PALMOLIVE |
Manufacturing (CMC) |
Approval |
| 12/21/2015 |
EXFORGE
NDA #021990 |
SUPPL-27 |
AMLODIPINE BESYLATE; VALSARTAN |
NOVARTIS |
Manufacturing (CMC) |
Approval |
| 12/21/2015 |
TEKTURNA HCT
NDA #022107 |
SUPPL-27 |
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE |
NODEN PHARMA |
Manufacturing (CMC) |
Approval |
| 12/21/2015 |
RAPAFLO
NDA #022206 |
SUPPL-10 |
SILODOSIN |
ABBVIE |
Manufacturing (CMC) |
Approval |
| 12/21/2015 |
TOPOTECAN HYDROCHLORIDE
NDA #022453 |
SUPPL-8 |
TOPOTECAN HYDROCHLORIDE |
MEITHEAL |
Manufacturing (CMC) |
Approval |
| 12/21/2015 |
LAZANDA
NDA #022569 |
SUPPL-22 |
FENTANYL CITRATE |
BTCP PHARMA |
Manufacturing (CMC) |
Approval |
| 12/21/2015 |
DOXYCYCLINE HYCLATE
ANDA #065281 |
SUPPL-2 |
DOXYCYCLINE HYCLATE |
BAUSCH |
Labeling |
Approval |
| 12/21/2015 |
ETODOLAC
ANDA #074844 |
SUPPL-5 |
ETODOLAC |
ANI PHARMS |
Labeling |
Approval |
| 12/21/2015 |
RAMIPRIL
ANDA #076549 |
SUPPL-16 |
RAMIPRIL |
WATSON LABS |
Labeling |
Approval |
| 12/21/2015 |
RAMIPRIL
ANDA #076549 |
SUPPL-17 |
RAMIPRIL |
WATSON LABS |
Labeling |
Approval |
| 12/21/2015 |
AMLODIPINE BESYLATE
ANDA #077955 |
SUPPL-11 |
AMLODIPINE BESYLATE |
INVAGEN PHARMS |
Labeling |
Approval |
| 12/21/2015 |
LINEZOLID
ANDA #078845 |
ORIG-1 |
LINEZOLID |
RISING |
|
Approval |
| 12/21/2015 |
LINEZOLID
ANDA #078987 |
ORIG-1 |
LINEZOLID |
GLENMARK SPECLT |
|
Approval |
| 12/21/2015 |
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #079108 |
ORIG-4 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
IMPAX LABS INC |
|
Approval |
| 12/21/2015 |
AMLODIPINE BESYLATE AND VALSARTAN
ANDA #090245 |
SUPPL-1 |
AMLODIPINE BESYLATE; VALSARTAN |
LUPIN |
Labeling |
Approval |
| 12/21/2015 |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #200797 |
SUPPL-1 |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
LUPIN LTD |
Labeling |
Approval |
| 12/21/2015 |
TRANEXAMIC ACID
ANDA #201885 |
SUPPL-2 |
TRANEXAMIC ACID |
AM REGENT |
Labeling |
Approval |
| 12/21/2015 |
TRANEXAMIC ACID
ANDA #201885 |
SUPPL-3 |
TRANEXAMIC ACID |
AM REGENT |
Labeling |
Approval |
| 12/21/2015 |
SILDENAFIL CITRATE
ANDA #202503 |
SUPPL-1 |
SILDENAFIL CITRATE |
WATSON LABS INC |
Labeling |
Approval |
| 12/21/2015 |
SILDENAFIL CITRATE
ANDA #202503 |
SUPPL-3 |
SILDENAFIL CITRATE |
WATSON LABS INC |
Labeling |
Approval |
| 12/21/2015 |
DUOPA
NDA #203952 |
SUPPL-2 |
CARBIDOPA; LEVODOPA |
ABBVIE |
Manufacturing (CMC) |
Approval |
| 12/21/2015 |
LINEZOLID
ANDA #204239 |
ORIG-1 |
LINEZOLID |
HETERO LABS LTD V |
|
Approval |
| 12/21/2015 |
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #204266 |
ORIG-2 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
AUROLIFE PHARMA LLC |
|
Approval |
| 12/21/2015 |
LINEZOLID
ANDA #204536 |
ORIG-1 |
LINEZOLID |
AMNEAL PHARMS |
|
Approval |
| 12/21/2015 |
LINEZOLID
ANDA #205233 |
ORIG-1 |
LINEZOLID |
ALEMBIC |
|
Approval |
| 12/21/2015 |
OTEZLA
NDA #205437 |
SUPPL-5 |
APREMILAST |
AMGEN INC |
Labeling |
Approval |
| 12/21/2015 |
LINEZOLID
ANDA #205517 |
ORIG-1 |
LINEZOLID |
ALKEM LABS LTD |
|
Approval |
| 12/21/2015 |
UPTRAVI
NDA #207947 |
ORIG-1 |
SELEXIPAG |
ACTELION |
Type 1 - New Molecular Entity |
Approval |
| 12/22/2015 |
XELODA
NDA #020896 |
SUPPL-38 |
CAPECITABINE |
CHEPLAPHARM |
Manufacturing (CMC) |
Approval |
| 12/22/2015 |
FEMCON FE
NDA #021490 |
SUPPL-16 |
ETHINYL ESTRADIOL; NORETHINDRONE |
APIL |
Manufacturing (CMC) |
Approval |
| 12/22/2015 |
TEKTURNA
NDA #021985 |
SUPPL-28 |
ALISKIREN HEMIFUMARATE |
NODEN PHARMA |
Labeling |
Approval |
| 12/22/2015 |
TEKTURNA HCT
NDA #022107 |
SUPPL-26 |
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE |
NODEN PHARMA |
Labeling |
Approval |
| 12/22/2015 |
TEKAMLO
NDA #022545 |
SUPPL-17 |
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE |
NOVARTIS |
Labeling |
Approval |
| 12/22/2015 |
SULINDAC
ANDA #071891 |
SUPPL-40 |
SULINDAC |
WATSON LABS |
Labeling |
Approval |
| 12/22/2015 |
SULINDAC
ANDA #073039 |
SUPPL-17 |
SULINDAC |
RISING |
Labeling |
Approval |
| 12/22/2015 |
VALPROATE SODIUM
ANDA #076539 |
SUPPL-5 |
VALPROATE SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
| 12/22/2015 |
VALPROATE SODIUM
ANDA #076539 |
SUPPL-6 |
VALPROATE SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
| 12/22/2015 |
VALPROATE SODIUM
ANDA #076539 |
SUPPL-7 |
VALPROATE SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
| 12/22/2015 |
VALPROATE SODIUM
ANDA #076539 |
SUPPL-8 |
VALPROATE SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
| 12/22/2015 |
VALPROATE SODIUM
ANDA #076539 |
SUPPL-9 |
VALPROATE SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
| 12/22/2015 |
DASETTA 7/7/7
ANDA #090946 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE |
NOVAST LABS LTD |
Labeling |
Approval |
| 12/22/2015 |
DASETTA 7/7/7
ANDA #090946 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE |
NOVAST LABS LTD |
Labeling |
Approval |
| 12/22/2015 |
DASETTA 7/7/7
ANDA #090946 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE |
NOVAST LABS LTD |
Labeling |
Approval |
| 12/22/2015 |
BETASERON
BLA #103471 |
SUPPL-5188 |
INTERFERON BETA-1B |
BAYER HEALTHCARE PHARMS |
|
Approval |
| 12/22/2015 |
AVONEX
BLA #103628 |
SUPPL-5258 |
INTERFERON BETA-1A |
BIOGEN |
|
Approval |
| 12/22/2015 |
REBIF
BLA #103780 |
SUPPL-5194 |
INTERFERON BETA-1A |
SERONO INC |
|
Approval |
| 12/22/2015 |
Xeomin
BLA #125360 |
SUPPL-67 |
incobotulinumtoxinA |
MERZ PHARMS |
|
Approval |
| 12/22/2015 |
PLEGRIDY
BLA #125499 |
SUPPL-9 |
PEGINTERFERON BETA-1A |
BIOGEN IDEC INC |
|
Approval |
| 12/22/2015 |
AMTURNIDE
NDA #200045 |
SUPPL-17 |
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE |
NOVARTIS |
Labeling |
Approval |
| 12/22/2015 |
BUSULFAN
ANDA #202259 |
ORIG-1 |
BUSULFAN |
AM REGENT |
|
Approval |
| 12/22/2015 |
DULOXETINE HYDROCHLORIDE
ANDA #203088 |
SUPPL-3 |
DULOXETINE HYDROCHLORIDE |
BRECKENRIDGE |
Manufacturing (CMC) |
Approval |
| 12/22/2015 |
XELJANZ
NDA #203214 |
SUPPL-11 |
TOFACITINIB CITRATE |
PF PRISM CV |
Labeling |
Approval |
| 12/22/2015 |
LEVONORGESTREL AND ETHINYL ESTRADIOL
ANDA #203872 |
ORIG-1 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
AMNEAL PHARMS |
|
Approval |
| 12/22/2015 |
TRAMADOL HYDROCHLORIDE
ANDA #205257 |
ORIG-1 |
TRAMADOL HYDROCHLORIDE |
MYLAN |
|
Approval |
| 12/22/2015 |
PROPOFOL
ANDA #205307 |
ORIG-1 |
PROPOFOL |
WATSON LABS INC |
|
Approval |
| 12/22/2015 |
ABACAVIR SULFATE; LAMIVUDINE
ANDA #205412 |
SUPPL-1 |
ABACAVIR SULFATE;LAMIVUDINE |
HETERO LABS LTD V |
Labeling |
Approval |
| 12/22/2015 |
DOCETAXEL
NDA #205934 |
ORIG-1 |
DOCETAXEL |
SHILPA |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 12/22/2015 |
FAMOTIDINE
ANDA #206530 |
ORIG-1 |
FAMOTIDINE |
AUROBINDO PHARMA LTD |
|
Approval |
| 12/22/2015 |
ZURAMPIC
NDA #207988 |
ORIG-1 |
LESINURAD |
IRONWOOD PHARMS INC |
Type 1 - New Molecular Entity |
Approval |
| 12/23/2015 |
CHLOR-TRIMETON
NDA #007638 |
SUPPL-38 |
CHLORPHENIRAMINE MALEATE |
BAYER HEALTHCARE LLC |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
OSMITROL 10% IN WATER
NDA #013684 |
SUPPL-101 |
MANNITOL |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
OSMITROL 10% IN WATER IN PLASTIC CONTAINER
NDA #013684 |
SUPPL-101 |
MANNITOL |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
OSMITROL 15% IN WATER
NDA #013684 |
SUPPL-101 |
MANNITOL |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
OSMITROL 15% IN WATER IN PLASTIC CONTAINER
NDA #013684 |
SUPPL-101 |
MANNITOL |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
OSMITROL 20% IN WATER
NDA #013684 |
SUPPL-101 |
MANNITOL |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
OSMITROL 20% IN WATER IN PLASTIC CONTAINER
NDA #013684 |
SUPPL-101 |
MANNITOL |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
OSMITROL 5% IN WATER
NDA #013684 |
SUPPL-101 |
MANNITOL |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
OSMITROL 5% IN WATER IN PLASTIC CONTAINER
NDA #013684 |
SUPPL-101 |
MANNITOL |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016678 |
SUPPL-108 |
DEXTROSE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
HEPARIN SODIUM
NDA #017029 |
SUPPL-129 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5%
NDA #017029 |
SUPPL-129 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%
NDA #017029 |
SUPPL-129 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45%
NDA #017029 |
SUPPL-129 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
HEPARIN SODIUM IN PLASTIC CONTAINER
NDA #017029 |
SUPPL-129 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
HEPARIN SODIUM PRESERVATIVE FREE
NDA #017029 |
SUPPL-129 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
HEPARIN SODIUM
NDA #017037 |
SUPPL-175 |
HEPARIN SODIUM |
HIKMA |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
PYRIDOSTIGMINE BROMIDE
NDA #020414 |
SUPPL-4 |
PYRIDOSTIGMINE BROMIDE |
US ARMY |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
FEMARA
NDA #020726 |
SUPPL-29 |
LETROZOLE |
NOVARTIS PHARMS |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
LIPOFEN
NDA #021612 |
SUPPL-16 |
FENOFIBRATE |
CIPHER PHARMS INC |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
CHILDREN'S CLARITIN
NDA #021891 |
SUPPL-20 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
| 12/23/2015 |
CLARITIN
NDA #021891 |
SUPPL-20 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
| 12/23/2015 |
ABSORICA
NDA #021951 |
SUPPL-6 |
ISOTRETINOIN |
SUN PHARM INDS INC |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
ZYPREXA RELPREVV
NDA #022173 |
SUPPL-19 |
OLANZAPINE PAMOATE |
CHEPLAPHARM |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
BYDUREON
NDA #022200 |
SUPPL-22 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
BYDUREON PEN
NDA #022200 |
SUPPL-22 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
ELELYSO
BLA #022458 |
SUPPL-8 |
TALIGLUCERASE ALFA |
PFIZER |
|
Approval |
| 12/23/2015 |
MYFORTIC
NDA #050791 |
SUPPL-23 |
MYCOPHENOLIC SODIUM |
NOVARTIS |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
DOXYCYCLINE HYCLATE
ANDA #062677 |
SUPPL-43 |
DOXYCYCLINE HYCLATE |
SUN PHARM INDUSTRIES |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
ACETAMINOPHEN
ANDA #076200 |
SUPPL-22 |
ACETAMINOPHEN |
OHM LABS |
Labeling |
Approval |
| 12/23/2015 |
VALPROIC ACID
ANDA #077105 |
SUPPL-7 |
VALPROIC ACID |
NOSTRUM LABS INC |
Labeling |
Approval |
| 12/23/2015 |
VALPROIC ACID
ANDA #077105 |
SUPPL-8 |
VALPROIC ACID |
NOSTRUM LABS INC |
Labeling |
Approval |
| 12/23/2015 |
VALPROIC ACID
ANDA #077105 |
SUPPL-9 |
VALPROIC ACID |
NOSTRUM LABS INC |
Labeling |
Approval |
| 12/23/2015 |
VALPROIC ACID
ANDA #077105 |
SUPPL-10 |
VALPROIC ACID |
NOSTRUM LABS INC |
Labeling |
Approval |
| 12/23/2015 |
SERTRALINE HYDROCHLORIDE
ANDA #077670 |
SUPPL-25 |
SERTRALINE HYDROCHLORIDE |
LUPIN |
Labeling |
Approval |
| 12/23/2015 |
SERTRALINE HYDROCHLORIDE
ANDA #077977 |
SUPPL-12 |
SERTRALINE HYDROCHLORIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 12/23/2015 |
FINASTERIDE
ANDA #078341 |
SUPPL-15 |
FINASTERIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 12/23/2015 |
ALPRAZOLAM
ANDA #078449 |
SUPPL-1 |
ALPRAZOLAM |
APOTEX INC |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
ALPRAZOLAM
ANDA #078449 |
SUPPL-2 |
ALPRAZOLAM |
APOTEX INC |
Labeling |
Approval |
| 12/23/2015 |
LAMOTRIGINE
ANDA #078625 |
SUPPL-1 |
LAMOTRIGINE |
RUBICON |
Labeling |
Approval |
| 12/23/2015 |
LAMOTRIGINE
ANDA #078625 |
SUPPL-7 |
LAMOTRIGINE |
RUBICON |
Labeling |
Approval |
| 12/23/2015 |
LAMOTRIGINE
ANDA #078625 |
SUPPL-8 |
LAMOTRIGINE |
RUBICON |
Labeling |
Approval |
| 12/23/2015 |
LAMOTRIGINE
ANDA #078625 |
SUPPL-9 |
LAMOTRIGINE |
RUBICON |
Labeling |
Approval |
| 12/23/2015 |
ACETAMINOPHEN
ANDA #090205 |
SUPPL-3 |
ACETAMINOPHEN |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 12/23/2015 |
EPIRUBICIN HYDROCHLORIDE
ANDA #091599 |
SUPPL-3 |
EPIRUBICIN HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
| 12/23/2015 |
VANCOMYCIN HYDROCHLORIDE
ANDA #201250 |
ORIG-1 |
VANCOMYCIN HYDROCHLORIDE |
TEVA PHARMS USA |
|
Approval |
| 12/23/2015 |
VANCOMYCIN HYDROCHLORIDE
ANDA #201251 |
ORIG-1 |
VANCOMYCIN HYDROCHLORIDE |
TEVA PHARMS USA |
|
Approval |
| 12/23/2015 |
DONEPEZIL HYDROCHLORIDE
ANDA #202542 |
SUPPL-2 |
DONEPEZIL HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 12/23/2015 |
DONEPEZIL HYDROCHLORIDE
ANDA #202542 |
SUPPL-4 |
DONEPEZIL HYDROCHLORIDE |
ENDO OPERATIONS |
Labeling |
Approval |
| 12/23/2015 |
ACITRETIN
ANDA #202552 |
ORIG-1 |
ACITRETIN |
IMPAX LABS INC |
|
Approval |
| 12/23/2015 |
OXTELLAR XR
NDA #202810 |
SUPPL-6 |
OXCARBAZEPINE |
SUPERNUS PHARMS |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
FYCOMPA
NDA #202834 |
SUPPL-9 |
PERAMPANEL |
CATALYST PHARMS |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
ANDA #202993 |
ORIG-1 |
DEXTROMETHORPHAN HYDROBROMIDE;QUINIDINE SULFATE |
PAR PHARM INC |
|
Tentative Approval |
| 12/23/2015 |
INVOKAMET
NDA #204353 |
SUPPL-7 |
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
JANSSEN PHARMS |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
ADRENALIN
NDA #204640 |
SUPPL-2 |
EPINEPHRINE |
ENDO OPERATIONS |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
ALEVE PM
NDA #205352 |
SUPPL-7 |
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM |
BAYER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 12/23/2015 |
CITALOPRAM HYDROBROMIDE
ANDA #205407 |
ORIG-1 |
CITALOPRAM HYDROBROMIDE |
JUBILANT GENERICS |
|
Approval |
| 12/23/2015 |
VANCOMYCIN HYDROCHLORIDE
ANDA #206243 |
ORIG-1 |
VANCOMYCIN HYDROCHLORIDE |
XELLIA PHARMS APS |
|
Approval |
| 12/23/2015 |
GABAPENTIN
ANDA #206402 |
ORIG-1 |
GABAPENTIN |
ALKEM LABS LTD |
|
Approval |
| 12/23/2015 |
CELECOXIB
ANDA #207677 |
ORIG-1 |
CELECOXIB |
TORRENT |
|
Approval |
| 12/24/2015 |
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #017608 |
SUPPL-140 |
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
ICU MEDICAL INC |
Manufacturing (CMC) |
Approval |
| 12/24/2015 |
DULERA
NDA #022518 |
SUPPL-18 |
FORMOTEROL FUMARATE; MOMETASONE FUROATE |
ORGANON LLC |
Labeling |
Approval |
| 12/24/2015 |
LEVETIRACETAM
ANDA #090893 |
SUPPL-9 |
LEVETIRACETAM |
LUPIN LTD |
Labeling |
Approval |
| 12/24/2015 |
LEVETIRACETAM
ANDA #090893 |
SUPPL-10 |
LEVETIRACETAM |
LUPIN LTD |
Labeling |
Approval |
| 12/24/2015 |
TECFIDERA
NDA #204063 |
SUPPL-15 |
DIMETHYL FUMARATE |
BIOGEN INC |
Manufacturing (CMC) |
Approval |
| 12/24/2015 |
ZOLEDRONIC ACID
ANDA #204367 |
ORIG-1 |
ZOLEDRONIC ACID |
APOTEX |
|
Approval |
| 12/25/2015 |
MEDICAL AIR, USP
NDA #208835 |
ORIG-1 |
MEDICAL AIR |
CENTRAL WELDING SUPPLY |
Medical Gas |
Approval |
| 12/26/2015 |
VALPROIC ACID
ANDA #073229 |
SUPPL-12 |
VALPROIC ACID |
CATALENT |
Labeling |
Approval |
| 12/26/2015 |
VALPROIC ACID
ANDA #073229 |
SUPPL-13 |
VALPROIC ACID |
CATALENT |
Labeling |
Approval |
| 12/26/2015 |
DIFLUNISAL
ANDA #074400 |
SUPPL-4 |
DIFLUNISAL |
WATSON LABS |
Labeling |
Approval |
| 12/26/2015 |
LISINOPRIL
ANDA #076071 |
SUPPL-31 |
LISINOPRIL |
STRIDES PHARMA |
Labeling |
Approval |
| 12/26/2015 |
LEVETIRACETAM
ANDA #090906 |
SUPPL-7 |
LEVETIRACETAM |
LOTUS PHARM CO LTD |
Labeling |
Approval |
| 12/28/2015 |
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #018883 |
SUPPL-58 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Manufacturing (CMC) |
Approval |
| 12/28/2015 |
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883 |
SUPPL-58 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Manufacturing (CMC) |
Approval |
| 12/28/2015 |
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #018883 |
SUPPL-58 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Manufacturing (CMC) |
Approval |
| 12/28/2015 |
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883 |
SUPPL-58 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Manufacturing (CMC) |
Approval |
| 12/28/2015 |
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #018883 |
SUPPL-58 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Manufacturing (CMC) |
Approval |
| 12/28/2015 |
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883 |
SUPPL-58 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Manufacturing (CMC) |
Approval |
| 12/28/2015 |
CHG SCRUB
NDA #019258 |
SUPPL-22 |
CHLORHEXIDINE GLUCONATE |
ECOLAB |
Manufacturing (CMC) |
Approval |
| 12/28/2015 |
CIDA-STAT
NDA #019258 |
SUPPL-22 |
CHLORHEXIDINE GLUCONATE |
ECOLAB |
Manufacturing (CMC) |
Approval |
| 12/28/2015 |
PREMARIN
NDA #020216 |
SUPPL-81 |
ESTROGENS, CONJUGATED |
WYETH PHARMS |
Labeling |
Approval |
| 12/28/2015 |
GENOTROPIN
BLA #020280 |
SUPPL-82 |
SOMATROPIN |
PHARMACIA |
|
Approval |
| 12/28/2015 |
GENOTROPIN PRESERVATIVE FREE
BLA #020280 |
SUPPL-82 |
SOMATROPIN |
PHARMACIA |
|
Approval |
| 12/28/2015 |
FINACEA
NDA #021470 |
SUPPL-12 |
AZELAIC ACID |
LEO PHARMA AS |
Labeling |
Approval |
| 12/28/2015 |
DOXIL (LIPOSOMAL)
NDA #050718 |
SUPPL-50 |
DOXORUBICIN HYDROCHLORIDE |
BAXTER HLTHCARE CORP |
Manufacturing (CMC) |
Approval |
| 12/28/2015 |
CAYSTON
NDA #050814 |
SUPPL-16 |
AZTREONAM |
GILEAD |
Manufacturing (CMC) |
Approval |
| 12/28/2015 |
MUPIROCIN
ANDA #065085 |
SUPPL-9 |
MUPIROCIN |
TEVA |
Labeling |
Approval |
| 12/28/2015 |
MUPIROCIN
ANDA #065085 |
SUPPL-10 |
MUPIROCIN |
TEVA |
Labeling |
Approval |
| 12/28/2015 |
AZITHROMYCIN
ANDA #065506 |
SUPPL-12 |
AZITHROMYCIN |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
| 12/28/2015 |
DEXTROAMPHETAMINE SULFATE
ANDA #076137 |
SUPPL-17 |
DEXTROAMPHETAMINE SULFATE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 12/28/2015 |
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #077107 |
SUPPL-11 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
TEVA PHARMS |
Labeling |
Approval |
| 12/28/2015 |
SIMVASTATIN
ANDA #077766 |
SUPPL-4 |
SIMVASTATIN |
CHARTWELL RX |
Labeling |
Approval |
| 12/28/2015 |
SIMVASTATIN
ANDA #077766 |
SUPPL-5 |
SIMVASTATIN |
CHARTWELL RX |
Labeling |
Approval |
| 12/28/2015 |
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
ANDA #077857 |
SUPPL-20 |
ENOXAPARIN SODIUM |
SANDOZ |
Labeling |
Approval |
| 12/28/2015 |
ENOXAPARIN SODIUM
ANDA #078660 |
SUPPL-12 |
ENOXAPARIN SODIUM |
SANDOZ INC |
Labeling |
Approval |
| 12/28/2015 |
DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #079108 |
SUPPL-3 |
DEXMETHYLPHENIDATE HYDROCHLORIDE |
IMPAX LABS INC |
Labeling |
Approval |
| 12/28/2015 |
IMIPENEM AND CILASTATIN
ANDA #091007 |
SUPPL-1 |
CILASTATIN SODIUM; IMIPENEM |
HOSPIRA INC |
Labeling |
Approval |
| 12/28/2015 |
IMIPENEM AND CILASTATIN
ANDA #091007 |
SUPPL-6 |
CILASTATIN SODIUM; IMIPENEM |
HOSPIRA INC |
Labeling |
Approval |
| 12/28/2015 |
NORETHINDRONE AND ETHINYL ESTRADIOL
ANDA #200486 |
ORIG-1 |
ETHINYL ESTRADIOL; NORETHINDRONE |
MYLAN LABS LTD |
|
Approval |
| 12/28/2015 |
GILOTRIF
NDA #201292 |
SUPPL-8 |
AFATINIB DIMALEATE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 12/28/2015 |
LEVETIRACETAM
ANDA #202143 |
SUPPL-2 |
LEVETIRACETAM |
AM REGENT |
Labeling |
Approval |
| 12/28/2015 |
LEVETIRACETAM
ANDA #202143 |
SUPPL-3 |
LEVETIRACETAM |
AM REGENT |
Labeling |
Approval |
| 12/28/2015 |
LEVETIRACETAM
ANDA #202143 |
SUPPL-4 |
LEVETIRACETAM |
AM REGENT |
Labeling |
Approval |
| 12/28/2015 |
IRBESARTAN
ANDA #202254 |
SUPPL-6 |
IRBESARTAN |
MACLEODS PHARMS LTD |
Labeling |
Approval |
| 12/28/2015 |
GABAPENTIN
ANDA #203244 |
SUPPL-2 |
GABAPENTIN |
STRIDES PHARMA |
Labeling |
Approval |
| 12/28/2015 |
GABAPENTIN
ANDA #203244 |
SUPPL-3 |
GABAPENTIN |
STRIDES PHARMA |
Labeling |
Approval |
| 12/28/2015 |
CEFAZOLIN SODIUM
ANDA #203661 |
ORIG-1 |
CEFAZOLIN SODIUM |
QILU |
|
Approval |
| 12/28/2015 |
ZOLEDRONIC ACID
NDA #204016 |
ORIG-1 |
ZOLEDRONIC ACID |
HOSPIRA |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 12/28/2015 |
VANCOMYCIN HYDROCHLORIDE
ANDA #204107 |
ORIG-1 |
VANCOMYCIN HYDROCHLORIDE |
HIKMA |
|
Approval |
| 12/28/2015 |
VANCOMYCIN HYDROCHLORIDE
ANDA #204125 |
ORIG-1 |
VANCOMYCIN HYDROCHLORIDE |
XELLIA PHARMS APS |
|
Approval |
| 12/28/2015 |
EPANED KIT
NDA #204308 |
SUPPL-4 |
ENALAPRIL MALEATE |
AZURITY |
Manufacturing (CMC) |
Approval |
| 12/28/2015 |
NEOSTIGMINE METHYLSULFATE
ANDA #207042 |
ORIG-1 |
NEOSTIGMINE METHYLSULFATE |
HIKMA |
|
Approval |
| 12/29/2015 |
HUMULIN R
BLA #018780 |
SUPPL-135 |
INSULIN HUMAN |
LILLY |
|
Approval |
| 12/29/2015 |
HUMULIN R
BLA #018780 |
SUPPL-152 |
INSULIN HUMAN |
LILLY |
|
Approval |
| 12/29/2015 |
HUMULIN R
BLA #018780 |
SUPPL-135 |
INSULIN RECOMBINANT HUMAN |
LILLY |
|
Approval |
| 12/29/2015 |
HUMULIN R
BLA #018780 |
SUPPL-152 |
INSULIN RECOMBINANT HUMAN |
LILLY |
|
Approval |
| 12/29/2015 |
HUMULIN R KWIKPEN
BLA #018780 |
SUPPL-135 |
INSULIN HUMAN |
LILLY |
|
Approval |
| 12/29/2015 |
HUMULIN R KWIKPEN
BLA #018780 |
SUPPL-152 |
INSULIN HUMAN |
LILLY |
|
Approval |
| 12/29/2015 |
HUMULIN R PEN
BLA #018780 |
SUPPL-135 |
INSULIN RECOMBINANT HUMAN |
LILLY |
|
Approval |
| 12/29/2015 |
HUMULIN R PEN
BLA #018780 |
SUPPL-152 |
INSULIN RECOMBINANT HUMAN |
LILLY |
|
Approval |
| 12/29/2015 |
NIPENT
NDA #020122 |
SUPPL-13 |
PENTOSTATIN |
HOSPIRA INC |
Manufacturing (CMC) |
Approval |
| 12/29/2015 |
COMPLERA
NDA #202123 |
SUPPL-22 |
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE |
GILEAD SCIENCES INC |
Manufacturing (CMC) |
Approval |
| 12/29/2015 |
POTASSIUM ACETATE
ANDA #206203 |
ORIG-1 |
POTASSIUM ACETATE |
EXELA PHARMA |
|
Approval |
| 12/29/2015 |
XTORO
NDA #206307 |
SUPPL-1 |
FINAFLOXACIN |
FONSECA BIOSCIENCES |
Manufacturing (CMC) |
Approval |
| 12/30/2015 |
REMERON
NDA #020415 |
SUPPL-32 |
MIRTAZAPINE |
ORGANON |
Labeling |
Approval |
| 12/30/2015 |
CLARITIN
NDA #020641 |
SUPPL-40 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
| 12/30/2015 |
CLARITIN HIVES RELIEF
NDA #020641 |
SUPPL-40 |
LORATADINE |
BAYER HEALTHCARE LLC |
Labeling |
Approval |
| 12/30/2015 |
REMERON SOLTAB
NDA #021208 |
SUPPL-22 |
MIRTAZAPINE |
ORGANON USA ORGANON |
Labeling |
Approval |
| 12/30/2015 |
IBUPROFEN
ANDA #070045 |
SUPPL-26 |
IBUPROFEN |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
| 12/30/2015 |
METOPROLOL TARTRATE
ANDA #075160 |
SUPPL-15 |
METOPROLOL TARTRATE |
HOSPIRA |
Labeling |
Approval |
| 12/30/2015 |
MUPIROCIN
ANDA #201587 |
SUPPL-1 |
MUPIROCIN CALCIUM |
GLENMARK PHARMS INC |
Labeling |
Approval |
| 12/30/2015 |
MUPIROCIN
ANDA #201587 |
SUPPL-3 |
MUPIROCIN CALCIUM |
GLENMARK PHARMS INC |
Labeling |
Approval |
| 12/30/2015 |
MINOCYCLINE HYDROCHLORIDE
ANDA #204394 |
ORIG-1 |
MINOCYCLINE HYDROCHLORIDE |
SUN PHARM |
|
Approval |
| 12/31/2015 |
LYBREL
NDA #021864 |
SUPPL-5 |
ETHINYL ESTRADIOL; LEVONORGESTREL |
WYETH PHARMS INC |
Manufacturing (CMC) |
Approval |
| 12/31/2015 |
BYDUREON
NDA #022200 |
SUPPL-21 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Manufacturing (CMC) |
Approval |
| 12/31/2015 |
BYDUREON PEN
NDA #022200 |
SUPPL-21 |
EXENATIDE SYNTHETIC |
ASTRAZENECA AB |
Manufacturing (CMC) |
Approval |
| 12/31/2015 |
OXALIPLATIN
ANDA #078803 |
SUPPL-3 |
OXALIPLATIN |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 12/31/2015 |
OXALIPLATIN
ANDA #078803 |
SUPPL-4 |
OXALIPLATIN |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 12/31/2015 |
LAMIVUDINE
ANDA #091606 |
SUPPL-1 |
LAMIVUDINE |
APOTEX |
Labeling |
Approval |
| 12/31/2015 |
LAMIVUDINE
ANDA #091606 |
SUPPL-3 |
LAMIVUDINE |
APOTEX |
Labeling |
Approval |
| 12/31/2015 |
LAMIVUDINE
ANDA #091606 |
SUPPL-4 |
LAMIVUDINE |
APOTEX |
Labeling |
Approval |
| 12/31/2015 |
LAMIVUDINE
ANDA #091606 |
SUPPL-5 |
LAMIVUDINE |
APOTEX |
Labeling |
Approval |
| 12/31/2015 |
LAMIVUDINE
ANDA #091606 |
SUPPL-6 |
LAMIVUDINE |
APOTEX |
Labeling |
Approval |
| 12/31/2015 |
DRONEDARONE HYDROCHLORIDE
ANDA #205682 |
ORIG-1 |
DRONEDARONE HYDROCHLORIDE |
WATSON LABS INC |
|
Tentative Approval |
| 12/31/2015 |
DRONEDARONE HYDROCHLORIDE
ANDA #205895 |
ORIG-1 |
DRONEDARONE HYDROCHLORIDE |
ALKEM LABS LTD |
|
Tentative Approval |
| 12/31/2015 |
DRONEDARONE HYDROCHLORIDE
ANDA #205903 |
ORIG-1 |
DRONEDARONE HYDROCHLORIDE |
GLENMARK GENERICS |
|
Tentative Approval |
