| 01/02/2015 |
OMEPRAZOLE
ANDA #075576 |
SUPPL-11 |
OMEPRAZOLE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 01/02/2015 |
OMEPRAZOLE
ANDA #075576 |
SUPPL-12 |
OMEPRAZOLE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 01/02/2015 |
OMEPRAZOLE
ANDA #075576 |
SUPPL-14 |
OMEPRAZOLE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 01/02/2015 |
IRINOTECAN HYDROCHLORIDE
ANDA #077915 |
SUPPL-6 |
IRINOTECAN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 01/02/2015 |
IRINOTECAN HYDROCHLORIDE
ANDA #078796 |
SUPPL-6 |
IRINOTECAN HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 01/02/2015 |
ZOLPIDEM TARTRATE
ANDA #090107 |
SUPPL-4 |
ZOLPIDEM TARTRATE |
SANDOZ |
Labeling |
Approval |
| 01/02/2015 |
ZOLPIDEM TARTRATE
ANDA #090107 |
SUPPL-5 |
ZOLPIDEM TARTRATE |
SANDOZ |
Labeling |
Approval |
| 01/02/2015 |
IRINOTECAN HYDROCHLORIDE
ANDA #091032 |
SUPPL-3 |
IRINOTECAN HYDROCHLORIDE |
HIKMA FARMACEUTICA |
Labeling |
Approval |
| 01/02/2015 |
REMICADE
BLA #103772 |
SUPPL-5370 |
INFLIXIMAB |
CENTOCOR INC |
|
Approval |
| 01/02/2015 |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #200435 |
SUPPL-1 |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TEVA PHARMS |
Labeling |
Approval |
| 01/02/2015 |
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #200435 |
SUPPL-3 |
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN |
TEVA PHARMS |
Labeling |
Approval |
| 01/02/2015 |
PANTOPRAZOLE SODIUM
ANDA #200794 |
SUPPL-3 |
PANTOPRAZOLE SODIUM |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 01/02/2015 |
PANTOPRAZOLE SODIUM
ANDA #200794 |
SUPPL-4 |
PANTOPRAZOLE SODIUM |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 01/02/2015 |
PANTOPRAZOLE SODIUM
ANDA #202038 |
SUPPL-4 |
PANTOPRAZOLE SODIUM |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/02/2015 |
TELMISARTAN AND AMLODIPINE
ANDA #202516 |
SUPPL-1 |
AMLODIPINE BESYLATE; TELMISARTAN |
MYLAN |
Labeling |
Approval |
| 01/02/2015 |
ZOLEDRONIC ACID
ANDA #202930 |
SUPPL-1 |
ZOLEDRONIC ACID |
GLAND PHARMA LTD |
Labeling |
Approval |
| 01/02/2015 |
ZOLEDRONIC ACID
ANDA #202930 |
SUPPL-2 |
ZOLEDRONIC ACID |
GLAND PHARMA LTD |
Labeling |
Approval |
| 01/02/2015 |
ZOLEDRONIC ACID
ANDA #202930 |
SUPPL-3 |
ZOLEDRONIC ACID |
GLAND PHARMA LTD |
Labeling |
Approval |
| 01/02/2015 |
VAZCULEP
NDA #204300 |
SUPPL-1 |
PHENYLEPHRINE HYDROCHLORIDE |
EXELA PHARMA |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
PONSTEL
NDA #015034 |
SUPPL-43 |
MEFENAMIC ACID |
AVION PHARMS |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
HEPARIN SODIUM
NDA #017037 |
SUPPL-173 |
HEPARIN SODIUM |
HIKMA |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
GLEOSTINE
NDA #017588 |
SUPPL-41 |
LOMUSTINE |
LATINA PHARMA |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
TECHNETIUM TC 99M GENERATOR
NDA #017693 |
SUPPL-27 |
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR |
GE HEALTHCARE |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
LITHOBID
NDA #018027 |
SUPPL-57 |
LITHIUM CARBONATE |
ANI PHARMS |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
ACETAMINOPHEN
NDA #018337 |
SUPPL-33 |
ACETAMINOPHEN |
TARO |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
INFANTS' FEVERALL
NDA #018337 |
SUPPL-33 |
ACETAMINOPHEN |
TARO |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
DRAXIMAGE DTPA
NDA #018511 |
SUPPL-26 |
TECHNETIUM TC-99M PENTETATE KIT |
JUBILANT |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
NICORETTE
NDA #018612 |
SUPPL-75 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
NICORETTE (MINT)
NDA #018612 |
SUPPL-75 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
PRALIDOXIME CHLORIDE (AUTOINJECTOR)
NDA #018986 |
SUPPL-45 |
PRALIDOXIME CHLORIDE |
MERIDIAN MEDCL TECHN |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
ATROVENT
NDA #020393 |
SUPPL-13 |
IPRATROPIUM BROMIDE |
BOEHRINGER INGELHEIM |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
TARKA
NDA #020591 |
SUPPL-24 |
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE |
ABBVIE |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
COLAZAL
NDA #020610 |
SUPPL-20 |
BALSALAZIDE DISODIUM |
VALEANT PHARMS INTL |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
CREON
BLA #020725 |
SUPPL-21 |
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) |
ABBVIE |
|
Approval |
| 01/05/2015 |
AVAPRO
NDA #020757 |
SUPPL-65 |
IRBESARTAN |
SANOFI AVENTIS US |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
XELODA
NDA #020896 |
SUPPL-35 |
CAPECITABINE |
CHEPLAPHARM |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
ZOMETA
NDA #021223 |
SUPPL-31 |
ZOLEDRONIC ACID |
NOVARTIS |
Labeling |
Approval |
| 01/05/2015 |
ADVIL PM
NDA #021394 |
SUPPL-19 |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
HALEON US HOLDINGS |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
FEMCON FE
NDA #021490 |
SUPPL-14 |
ETHINYL ESTRADIOL; NORETHINDRONE |
APIL |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
VENTAVIS
NDA #021779 |
SUPPL-16 |
ILOPROST |
ACTELION |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
JANUMET
NDA #022044 |
SUPPL-32 |
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
MSD SUB MERCK |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
ATRALIN
NDA #022070 |
SUPPL-4 |
TRETINOIN |
DOW PHARM |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
XYZAL
NDA #022157 |
SUPPL-10 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
CHATTEM SANOFI |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
ORAVERSE
NDA #022159 |
SUPPL-8 |
PHENTOLAMINE MESYLATE |
SEPTODONT HOLDING |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
GIAZO
NDA #022205 |
SUPPL-2 |
BALSALAZIDE DISODIUM |
VALEANT PHARMS INTL |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
CONZIP
NDA #022370 |
SUPPL-10 |
TRAMADOL HYDROCHLORIDE |
CIPHER PHARMS INC |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
ZANOSAR
NDA #050577 |
SUPPL-40 |
STREPTOZOCIN |
TEVA PHARMS USA |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
ZANOSAR
NDA #050577 |
SUPPL-41 |
STREPTOZOCIN |
TEVA PHARMS USA |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
DESIPRAMINE HYDROCHLORIDE
ANDA #071588 |
SUPPL-28 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 01/05/2015 |
DESIPRAMINE HYDROCHLORIDE
ANDA #071601 |
SUPPL-29 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 01/05/2015 |
DESIPRAMINE HYDROCHLORIDE
ANDA #071602 |
SUPPL-27 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 01/05/2015 |
DESIPRAMINE HYDROCHLORIDE
ANDA #071766 |
SUPPL-28 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 01/05/2015 |
CLOTRIMAZOLE
ANDA #074165 |
SUPPL-38 |
CLOTRIMAZOLE |
P AND L |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
DESIPRAMINE HYDROCHLORIDE
ANDA #074430 |
SUPPL-17 |
DESIPRAMINE HYDROCHLORIDE |
ACTAVIS TOTOWA |
Labeling |
Approval |
| 01/05/2015 |
VALSARTAN
ANDA #090642 |
ORIG-1 |
VALSARTAN |
WATSON LABS INC |
|
Approval |
| 01/05/2015 |
VALSARTAN
ANDA #090866 |
ORIG-1 |
VALSARTAN |
MYLAN |
|
Approval |
| 01/05/2015 |
VALSARTAN
ANDA #091367 |
ORIG-1 |
VALSARTAN |
ALEMBIC |
|
Approval |
| 01/05/2015 |
LAMOTRIGINE
ANDA #200220 |
SUPPL-3 |
LAMOTRIGINE |
JUBILANT GENERICS |
Labeling |
Approval |
| 01/05/2015 |
LAMOTRIGINE
ANDA #200220 |
SUPPL-5 |
LAMOTRIGINE |
JUBILANT GENERICS |
Labeling |
Approval |
| 01/05/2015 |
LATUDA
NDA #200603 |
SUPPL-18 |
LURASIDONE HYDROCHLORIDE |
SUNOVION PHARMS INC |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
JEVTANA KIT
NDA #201023 |
SUPPL-13 |
CABAZITAXEL |
SANOFI AVENTIS US |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
BANZEL
NDA #201367 |
SUPPL-2 |
RUFINAMIDE |
EISAI INC |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
VALSARTAN
ANDA #201677 |
ORIG-1 |
VALSARTAN |
LUPIN LTD |
|
Approval |
| 01/05/2015 |
TEMOZOLOMIDE
ANDA #201742 |
SUPPL-1 |
TEMOZOLOMIDE |
SUN PHARM |
Labeling |
Approval |
| 01/05/2015 |
VALSARTAN
ANDA #202223 |
ORIG-1 |
VALSARTAN |
AUROBINDO PHARMA LTD |
|
Approval |
| 01/05/2015 |
VALSARTAN
ANDA #202728 |
ORIG-1 |
VALSARTAN |
TORRENT |
|
Approval |
| 01/05/2015 |
LINZESS
NDA #202811 |
SUPPL-6 |
LINACLOTIDE |
ABBVIE |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
ABILIFY MAINTENA KIT
NDA #202971 |
SUPPL-5 |
ARIPIPRAZOLE |
OTSUKA PHARM CO LTD |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
KALYDECO
NDA #203188 |
SUPPL-16 |
IVACAFTOR |
VERTEX PHARMS |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
RAVICTI
NDA #203284 |
SUPPL-2 |
GLYCEROL PHENYLBUTYRATE |
HORIZON THERAP US |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
VALSARTAN
ANDA #203311 |
ORIG-1 |
VALSARTAN |
HETERO LABS LTD V |
|
Approval |
| 01/05/2015 |
GATTEX KIT
NDA #203441 |
SUPPL-4 |
TEDUGLUTIDE |
TAKEDA PHARMS USA |
Manufacturing (CMC) |
Approval |
| 01/05/2015 |
VALSARTAN
ANDA #203536 |
ORIG-1 |
VALSARTAN |
JUBILANT GENERICS |
|
Approval |
| 01/06/2015 |
ZEMURON
NDA #020214 |
SUPPL-36 |
ROCURONIUM BROMIDE |
ORGANON USA INC |
Labeling |
Approval |
| 01/06/2015 |
MEPERIDINE HYDROCHLORIDE
ANDA #040191 |
SUPPL-8 |
MEPERIDINE HYDROCHLORIDE |
STRIDES PHARMA |
Labeling |
Approval |
| 01/06/2015 |
BACTOCILL IN PLASTIC CONTAINER
NDA #050640 |
SUPPL-17 |
OXACILLIN SODIUM |
BAXTER HLTHCARE |
Labeling |
Approval |
| 01/07/2015 |
DEPAKENE
NDA #018081 |
SUPPL-59 |
VALPROIC ACID |
ABBVIE |
Labeling |
Approval |
| 01/07/2015 |
DEPAKENE
NDA #018082 |
SUPPL-42 |
VALPROIC ACID |
ABBVIE |
Labeling |
Approval |
| 01/07/2015 |
DEPAKOTE
NDA #018723 |
SUPPL-51 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
| 01/07/2015 |
DEPAKOTE
NDA #019680 |
SUPPL-38 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
| 01/07/2015 |
DEPACON
NDA #020593 |
SUPPL-29 |
VALPROATE SODIUM |
ABBVIE |
Labeling |
Approval |
| 01/07/2015 |
LIDODERM
NDA #020612 |
SUPPL-12 |
LIDOCAINE |
TEIKOKU PHARMA USA |
Labeling |
Approval |
| 01/07/2015 |
METROLOTION
NDA #020901 |
SUPPL-3 |
METRONIDAZOLE |
GALDERMA LABS LP |
Labeling |
Approval |
| 01/07/2015 |
DEPAKOTE ER
NDA #021168 |
SUPPL-27 |
DIVALPROEX SODIUM |
ABBVIE |
Labeling |
Approval |
| 01/07/2015 |
PUR-WASH
NDA #022305 |
SUPPL-4 |
PURIFIED WATER |
NIAGARA PHARMS |
Manufacturing (CMC) |
Approval |
| 01/07/2015 |
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
ANDA #075735 |
SUPPL-8 |
NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE |
LUPIN |
Labeling |
Approval |
| 01/07/2015 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ANDA #076221 |
SUPPL-8 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
BARR LABS INC |
Labeling |
Approval |
| 01/07/2015 |
HALOPERIDOL
ANDA #077580 |
SUPPL-9 |
HALOPERIDOL |
ZYDUS PHARMS USA |
Manufacturing (CMC) |
Approval |
| 01/07/2015 |
TRIDERM
ANDA #088042 |
SUPPL-5 |
TRIAMCINOLONE ACETONIDE |
CROWN LABS |
Labeling |
Approval |
| 01/07/2015 |
RAMIPRIL
ANDA #202392 |
SUPPL-1 |
RAMIPRIL |
ACCORD HLTHCARE |
Labeling |
Approval |
| 01/07/2015 |
RYTARY
NDA #203312 |
ORIG-1 |
CARBIDOPA; LEVODOPA |
IMPAX |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 01/07/2015 |
BIMATOPROST
ANDA #203404 |
ORIG-1 |
BIMATOPROST |
APOTEX INC |
|
Tentative Approval |
| 01/07/2015 |
FLUDEOXYGLUCOSE F18
ANDA #204512 |
ORIG-1 |
FLUDEOXYGLUCOSE F-18 |
NCM USA BRONX LLC |
|
Approval |
| 01/08/2015 |
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #018883 |
SUPPL-57 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Labeling |
Approval |
| 01/08/2015 |
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883 |
SUPPL-57 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Labeling |
Approval |
| 01/08/2015 |
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #018883 |
SUPPL-57 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Labeling |
Approval |
| 01/08/2015 |
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883 |
SUPPL-57 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Labeling |
Approval |
| 01/08/2015 |
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #018883 |
SUPPL-57 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Labeling |
Approval |
| 01/08/2015 |
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
NDA #018883 |
SUPPL-57 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Labeling |
Approval |
| 01/08/2015 |
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171 |
SUPPL-39 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Labeling |
Approval |
| 01/08/2015 |
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171 |
SUPPL-39 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Labeling |
Approval |
| 01/08/2015 |
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
NDA #020171 |
SUPPL-39 |
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
FRESENIUS MEDCL |
Labeling |
Approval |
| 01/08/2015 |
BIAXIN
NDA #050662 |
SUPPL-56 |
CLARITHROMYCIN |
ABBVIE |
Labeling |
Approval |
| 01/08/2015 |
BIAXIN
NDA #050698 |
SUPPL-36 |
CLARITHROMYCIN |
ABBVIE |
Labeling |
Approval |
| 01/08/2015 |
BIAXIN XL
NDA #050775 |
SUPPL-24 |
CLARITHROMYCIN |
ABBVIE |
Labeling |
Approval |
| 01/08/2015 |
LEVOFLOXACIN
ANDA #202801 |
ORIG-1 |
LEVOFLOXACIN |
HETERO LABS LTD V |
|
Approval |
| 01/08/2015 |
NEOSTIGMINE METHYLSULFATE
NDA #203629 |
ORIG-1 |
NEOSTIGMINE METHYLSULFATE |
FRESENIUS KABI USA |
Type 3 - New Dosage Form |
Approval |
| 01/08/2015 |
VARITHENA
NDA #205098 |
SUPPL-5 |
POLIDOCANOL |
PROVENSIS |
Labeling |
Approval |
| 01/08/2015 |
SAVAYSA
NDA #206316 |
ORIG-1 |
EDOXABAN TOSYLATE |
DAIICHI SANKYO INC |
Type 1 - New Molecular Entity |
Approval |
| 01/08/2015 |
SAVAYSA
NDA #206316 |
ORIG-2 |
EDOXABAN TOSYLATE |
DAIICHI SANKYO INC |
Efficacy |
Approval |
| 01/09/2015 |
PROCARDIA
NDA #018482 |
SUPPL-52 |
NIFEDIPINE |
PFIZER |
Labeling |
Approval |
| 01/09/2015 |
PROCARDIA XL
NDA #019684 |
SUPPL-29 |
NIFEDIPINE |
PFIZER |
Labeling |
Approval |
| 01/09/2015 |
FLUCONAZOLE
ANDA #076957 |
SUPPL-3 |
FLUCONAZOLE |
THINQ PHARM-CRO PVT |
Manufacturing (CMC) |
Approval |
| 01/09/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #079224 |
SUPPL-5 |
ONDANSETRON HYDROCHLORIDE |
GLAND PHARMA LTD |
Labeling |
Approval |
| 01/09/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #079224 |
SUPPL-6 |
ONDANSETRON HYDROCHLORIDE |
GLAND PHARMA LTD |
Labeling |
Approval |
| 01/09/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #090648 |
SUPPL-4 |
ONDANSETRON HYDROCHLORIDE |
GLAND PHARMA LTD |
Labeling |
Approval |
| 01/09/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #090648 |
SUPPL-6 |
ONDANSETRON HYDROCHLORIDE |
GLAND PHARMA LTD |
Labeling |
Approval |
| 01/09/2015 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #202600 |
SUPPL-4 |
ONDANSETRON HYDROCHLORIDE |
EUGIA PHARMA |
Labeling |
Approval |
| 01/09/2015 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #202600 |
SUPPL-6 |
ONDANSETRON HYDROCHLORIDE |
EUGIA PHARMA |
Labeling |
Approval |
| 01/09/2015 |
DUOPA
NDA #203952 |
ORIG-1 |
CARBIDOPA; LEVODOPA |
ABBVIE |
Type 3 - New Dosage Form |
Approval |
| 01/09/2015 |
SODIUM FLUORIDE F-18
ANDA #204351 |
ORIG-1 |
SODIUM FLUORIDE F-18 |
BIOMEDCL RES FDN |
|
Approval |
| 01/11/2015 |
NIFEDIPINE
ANDA #077127 |
SUPPL-2 |
NIFEDIPINE |
OSMOTICA PHARM US |
Labeling |
Approval |
| 01/11/2015 |
NIFEDIPINE
ANDA #077127 |
SUPPL-3 |
NIFEDIPINE |
OSMOTICA PHARM US |
Labeling |
Approval |
| 01/12/2015 |
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #016678 |
SUPPL-106 |
DEXTROSE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
NDA #016692 |
SUPPL-99 |
SODIUM LACTATE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%
NDA #017648 |
SUPPL-69 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%
NDA #017648 |
SUPPL-69 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%
NDA #017648 |
SUPPL-69 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%
NDA #017648 |
SUPPL-69 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075%
NDA #017648 |
SUPPL-69 |
POTASSIUM CHLORIDE; SODIUM CHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
PREGNYL
BLA #017692 |
SUPPL-25 |
GONADOTROPIN, CHORIONIC |
ORGANON USA INC |
|
Approval |
| 01/12/2015 |
REGLAN
NDA #017854 |
SUPPL-59 |
METOCLOPRAMIDE HYDROCHLORIDE |
ANI PHARMS |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
HUMULIN N
BLA #018781 |
SUPPL-153 |
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
LILLY |
|
Approval |
| 01/12/2015 |
SODIUM PHOSPHATES IN PLASTIC CONTAINER
NDA #018892 |
SUPPL-31 |
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
HOSPIRA |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
DESOGEN
NDA #020071 |
SUPPL-21 |
DESOGESTREL; ETHINYL ESTRADIOL |
ORGANON USA INC |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
ACTIVELLA
NDA #020907 |
SUPPL-15 |
ESTRADIOL; NORETHINDRONE ACETATE |
AMNEAL |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
VAGIFEM
NDA #020908 |
SUPPL-21 |
ESTRADIOL |
NOVO NORDISK INC |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
VENTOLIN HFA
NDA #020983 |
SUPPL-33 |
ALBUTEROL SULFATE |
GLAXOSMITHKLINE |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
GANIRELIX ACETATE
NDA #021057 |
SUPPL-13 |
GANIRELIX ACETATE |
ORGANON USA ORGANON |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
CAVERJECT IMPULSE
NDA #021212 |
SUPPL-12 |
ALPROSTADIL |
PFIZER |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
EMEND
NDA #021549 |
SUPPL-26 |
APREPITANT |
MERCK |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
METROGEL
NDA #021789 |
SUPPL-6 |
METRONIDAZOLE |
GALDERMA LABS LP |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
DESONATE
NDA #021844 |
SUPPL-9 |
DESONIDE |
LEO PHARMA AS |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
ATRIPLA
NDA #021937 |
SUPPL-35 |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
GILEAD SCIENCES |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
EMEND
NDA #022023 |
SUPPL-12 |
FOSAPREPITANT DIMEGLUMINE |
MERCK AND CO INC |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
CLEOCIN T
NDA #050615 |
SUPPL-13 |
CLINDAMYCIN PHOSPHATE |
PFIZER |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
CAYSTON
NDA #050814 |
SUPPL-15 |
AZTREONAM |
GILEAD |
Manufacturing (CMC) |
Approval |
| 01/12/2015 |
FLUOXETINE HYDROCHLORIDE
ANDA #076458 |
SUPPL-7 |
FLUOXETINE HYDROCHLORIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 01/12/2015 |
RANITIDINE HYDROCHLORIDE
ANDA #078653 |
SUPPL-3 |
RANITIDINE HYDROCHLORIDE |
WOCKHARDT |
Labeling |
Approval |
| 01/12/2015 |
LOSARTAN POTASSIUM
ANDA #090467 |
SUPPL-11 |
LOSARTAN POTASSIUM |
TORRENT PHARMS |
Labeling |
Approval |
| 01/12/2015 |
LOSARTAN POTASSIUM
ANDA #090467 |
SUPPL-13 |
LOSARTAN POTASSIUM |
TORRENT PHARMS |
Labeling |
Approval |
| 01/12/2015 |
RISPERIDONE
ANDA #202386 |
ORIG-1 |
RISPERIDONE |
CHARTWELL MOLECULAR |
|
Approval |
| 01/12/2015 |
REVATIO
NDA #203109 |
SUPPL-7 |
SILDENAFIL CITRATE |
VIATRIS |
Manufacturing (CMC) |
Approval |
| 01/13/2015 |
LONITEN
NDA #018154 |
SUPPL-26 |
MINOXIDIL |
PFIZER |
Labeling |
Approval |
| 01/13/2015 |
THYRO-TABS
NDA #021116 |
SUPPL-12 |
LEVOTHYROXINE SODIUM |
ALVOGEN |
Labeling |
Approval |
| 01/13/2015 |
ALFUZOSIN HYDROCHLORIDE
ANDA #079014 |
SUPPL-6 |
ALFUZOSIN HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
| 01/13/2015 |
ALFUZOSIN HYDROCHLORIDE
ANDA #090284 |
SUPPL-4 |
ALFUZOSIN HYDROCHLORIDE |
INVAGEN PHARMS |
Labeling |
Approval |
| 01/13/2015 |
ALFUZOSIN HYDROCHLORIDE
ANDA #090284 |
SUPPL-5 |
ALFUZOSIN HYDROCHLORIDE |
INVAGEN PHARMS |
Labeling |
Approval |
| 01/13/2015 |
PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER
NDA #207026 |
ORIG-1 |
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE |
BAXTER HLTHCARE CORP |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 01/13/2015 |
PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER
NDA #207026 |
ORIG-1 |
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE |
BAXTER HLTHCARE CORP |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 01/14/2015 |
ISORDIL
NDA #012093 |
SUPPL-52 |
ISOSORBIDE DINITRATE |
BAUSCH |
Labeling |
Approval |
| 01/14/2015 |
NOVOLOG
BLA #020986 |
SUPPL-78 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/14/2015 |
NOVOLOG FLEXPEN
BLA #020986 |
SUPPL-78 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/14/2015 |
NOVOLOG FLEXTOUCH
BLA #020986 |
SUPPL-78 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/14/2015 |
NOVOLOG INNOLET
BLA #020986 |
SUPPL-78 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/14/2015 |
NOVOLOG PENFILL
BLA #020986 |
SUPPL-78 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/14/2015 |
DESMOPRESSIN ACETATE
ANDA #074830 |
SUPPL-17 |
DESMOPRESSIN ACETATE |
BAUSCH |
Manufacturing (CMC) |
Approval |
| 01/14/2015 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #078901 |
SUPPL-8 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 01/14/2015 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #078901 |
SUPPL-9 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 01/14/2015 |
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
ANDA #078901 |
SUPPL-10 |
FLUOXETINE HYDROCHLORIDE; OLANZAPINE |
EPIC PHARMA LLC |
Labeling |
Approval |
| 01/14/2015 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078945 |
SUPPL-1 |
ONDANSETRON HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 01/14/2015 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078945 |
SUPPL-5 |
ONDANSETRON HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 01/14/2015 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #078945 |
SUPPL-8 |
ONDANSETRON HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 01/14/2015 |
ALFUZOSIN HYDROCHLORIDE
ANDA #079060 |
SUPPL-3 |
ALFUZOSIN HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/14/2015 |
ALFUZOSIN HYDROCHLORIDE
ANDA #079060 |
SUPPL-4 |
ALFUZOSIN HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/14/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #091342 |
SUPPL-3 |
ONDANSETRON HYDROCHLORIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 01/15/2015 |
PROVIGIL
NDA #020717 |
SUPPL-37 |
MODAFINIL |
CEPHALON |
Labeling |
Approval |
| 01/15/2015 |
PROVIGIL
NDA #020717 |
SUPPL-38 |
MODAFINIL |
CEPHALON |
Labeling |
Approval |
| 01/15/2015 |
XARELTO
NDA #022406 |
SUPPL-12 |
RIVAROXABAN |
JANSSEN PHARMS |
Labeling |
Approval |
| 01/15/2015 |
PRADAXA
NDA #022512 |
SUPPL-24 |
DABIGATRAN ETEXILATE MESYLATE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
| 01/15/2015 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040480 |
SUPPL-10 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 01/15/2015 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040480 |
SUPPL-15 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 01/15/2015 |
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH
ANDA #070030 |
SUPPL-39 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
HERITAGE PHARMA AVET |
Labeling |
Approval |
| 01/15/2015 |
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
ANDA #070037 |
SUPPL-38 |
SULFAMETHOXAZOLE; TRIMETHOPRIM |
HERITAGE PHARMA AVET |
Labeling |
Approval |
| 01/15/2015 |
FLURAZEPAM HYDROCHLORIDE
ANDA #070345 |
SUPPL-17 |
FLURAZEPAM HYDROCHLORIDE |
RISING |
Labeling |
Approval |
| 01/15/2015 |
NITROFURANTOIN
ANDA #074967 |
SUPPL-12 |
NITROFURANTOIN, MACROCRYSTALLINE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 01/15/2015 |
MORPHINE SULFATE
ANDA #075656 |
SUPPL-7 |
MORPHINE SULFATE |
WATSON LABS |
Labeling |
Approval |
| 01/15/2015 |
NITROFURANTOIN
ANDA #077025 |
SUPPL-5 |
NITROFURANTOIN, MACROCRYSTALLINE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077387 |
SUPPL-4 |
ONDANSETRON HYDROCHLORIDE |
AM REGENT |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #077517 |
SUPPL-7 |
ONDANSETRON HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #077517 |
SUPPL-9 |
ONDANSETRON HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #077545 |
SUPPL-8 |
ONDANSETRON HYDROCHLORIDE |
HIKMA INTL PHARMS |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #077582 |
SUPPL-5 |
ONDANSETRON HYDROCHLORIDE |
AM REGENT |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #077729 |
SUPPL-2 |
ONDANSETRON HYDROCHLORIDE |
TARO |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #077729 |
SUPPL-3 |
ONDANSETRON HYDROCHLORIDE |
TARO |
Labeling |
Approval |
| 01/15/2015 |
OXCARBAZEPINE
ANDA #077801 |
SUPPL-4 |
OXCARBAZEPINE |
TARO |
Labeling |
Approval |
| 01/15/2015 |
OXCARBAZEPINE
ANDA #077801 |
SUPPL-5 |
OXCARBAZEPINE |
TARO |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #078127 |
SUPPL-5 |
ONDANSETRON HYDROCHLORIDE |
PHARM ASSOC |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #078127 |
SUPPL-6 |
ONDANSETRON HYDROCHLORIDE |
PHARM ASSOC |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #078127 |
SUPPL-7 |
ONDANSETRON HYDROCHLORIDE |
PHARM ASSOC |
Labeling |
Approval |
| 01/15/2015 |
LISINOPRIL
ANDA #078402 |
SUPPL-5 |
LISINOPRIL |
WOCKHARDT BIO AG |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #078539 |
SUPPL-6 |
ONDANSETRON HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #078539 |
SUPPL-7 |
ONDANSETRON HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON
ANDA #078602 |
SUPPL-2 |
ONDANSETRON |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON
ANDA #078602 |
SUPPL-3 |
ONDANSETRON |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 01/15/2015 |
ALFUZOSIN HYDROCHLORIDE
ANDA #079013 |
SUPPL-3 |
ALFUZOSIN HYDROCHLORIDE |
APOTEX INC |
Labeling |
Approval |
| 01/15/2015 |
ALFUZOSIN HYDROCHLORIDE
ANDA #079013 |
SUPPL-4 |
ALFUZOSIN HYDROCHLORIDE |
APOTEX INC |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON
ANDA #079032 |
SUPPL-5 |
ONDANSETRON |
AM REGENT |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #079032 |
SUPPL-5 |
ONDANSETRON HYDROCHLORIDE |
AM REGENT |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #079039 |
SUPPL-5 |
ONDANSETRON HYDROCHLORIDE |
LUITPOLD |
Labeling |
Approval |
| 01/15/2015 |
ALFUZOSIN HYDROCHLORIDE
ANDA #079054 |
SUPPL-6 |
ALFUZOSIN HYDROCHLORIDE |
TORRENT PHARMS |
Labeling |
Approval |
| 01/15/2015 |
ALFUZOSIN HYDROCHLORIDE
ANDA #079054 |
SUPPL-8 |
ALFUZOSIN HYDROCHLORIDE |
TORRENT PHARMS |
Labeling |
Approval |
| 01/15/2015 |
ALFUZOSIN HYDROCHLORIDE
ANDA #079054 |
SUPPL-10 |
ALFUZOSIN HYDROCHLORIDE |
TORRENT PHARMS |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #090424 |
SUPPL-2 |
ONDANSETRON HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #090424 |
SUPPL-4 |
ONDANSETRON HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #090424 |
SUPPL-5 |
ONDANSETRON HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 01/15/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #090424 |
SUPPL-8 |
ONDANSETRON HYDROCHLORIDE |
AVET LIFESCIENCES |
Labeling |
Approval |
| 01/15/2015 |
RITONAVIR
ANDA #202573 |
ORIG-1 |
RITONAVIR |
CIPLA |
|
Approval |
| 01/15/2015 |
PHENYLEPHRINE HYDROCHLORIDE
NDA #207926 |
ORIG-1 |
PHENYLEPHRINE HYDROCHLORIDE |
ALCON |
Type 7 - Drug Already Marketed without Approved NDA |
Approval |
| 01/16/2015 |
COMTAN
NDA #020796 |
SUPPL-24 |
ENTACAPONE |
ORION PHARMA |
Labeling |
Approval |
| 01/16/2015 |
BUSULFEX
NDA #020954 |
SUPPL-14 |
BUSULFAN |
OTSUKA PHARM |
Labeling |
Approval |
| 01/16/2015 |
CUTIVATE
NDA #021152 |
SUPPL-4 |
FLUTICASONE PROPIONATE |
FOUGERA PHARMS |
Efficacy |
Approval |
| 01/16/2015 |
BENZONATATE
ANDA #040627 |
SUPPL-1 |
BENZONATATE |
THEPHARMANETWORK LLC |
Labeling |
Approval |
| 01/16/2015 |
BENZONATATE
ANDA #040749 |
SUPPL-1 |
BENZONATATE |
THEPHARMANETWORK LLC |
Labeling |
Approval |
| 01/16/2015 |
DOXYCYCLINE
ANDA #065356 |
SUPPL-10 |
DOXYCYCLINE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 01/16/2015 |
CLINDAMYCIN HYDROCHLORIDE
ANDA #065442 |
SUPPL-7 |
CLINDAMYCIN HYDROCHLORIDE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/16/2015 |
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073007 |
SUPPL-25 |
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE |
CHARTWELL RX |
Labeling |
Approval |
| 01/16/2015 |
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073008 |
SUPPL-24 |
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE |
CHARTWELL RX |
Labeling |
Approval |
| 01/16/2015 |
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073009 |
SUPPL-25 |
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE |
CHARTWELL RX |
Labeling |
Approval |
| 01/16/2015 |
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #073010 |
SUPPL-25 |
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE |
CHARTWELL RX |
Labeling |
Approval |
| 01/16/2015 |
GLYBURIDE
ANDA #074388 |
SUPPL-43 |
GLYBURIDE |
TEVA |
Labeling |
Approval |
| 01/16/2015 |
OLANZAPINE
ANDA #076000 |
SUPPL-3 |
OLANZAPINE |
TEVA PHARMS |
Labeling |
Approval |
| 01/16/2015 |
MIRTAZAPINE
ANDA #076921 |
SUPPL-26 |
MIRTAZAPINE |
AUROBINDO |
Labeling |
Approval |
| 01/16/2015 |
MIRTAZAPINE
ANDA #077376 |
SUPPL-14 |
MIRTAZAPINE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/16/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #090116 |
SUPPL-5 |
ONDANSETRON HYDROCHLORIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
| 01/16/2015 |
AMOXICILLIN AND CLAVULANATE POTASSIUM
ANDA #090227 |
SUPPL-7 |
AMOXICILLIN; CLAVULANATE POTASSIUM |
SANDOZ |
Labeling |
Approval |
| 01/16/2015 |
DOXYCYCLINE HYCLATE
ANDA #090431 |
SUPPL-6 |
DOXYCYCLINE HYCLATE |
RISING |
Labeling |
Approval |
| 01/16/2015 |
VALPROIC ACID
ANDA #090517 |
SUPPL-2 |
VALPROIC ACID |
QUAGEN |
Labeling |
Approval |
| 01/16/2015 |
ANASTROZOLE
ANDA #090568 |
SUPPL-4 |
ANASTROZOLE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 01/16/2015 |
ANASTROZOLE
ANDA #090568 |
SUPPL-6 |
ANASTROZOLE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 01/16/2015 |
ANASTROZOLE
ANDA #090568 |
SUPPL-7 |
ANASTROZOLE |
ACCORD HLTHCARE |
Labeling |
Approval |
| 01/16/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #090883 |
SUPPL-5 |
ONDANSETRON HYDROCHLORIDE |
LANNETT CO INC |
Labeling |
Approval |
| 01/16/2015 |
LEVETIRACETAM
ANDA #090906 |
SUPPL-5 |
LEVETIRACETAM |
LOTUS PHARM CO LTD |
Labeling |
Approval |
| 01/16/2015 |
BENZONATATE
ANDA #091310 |
ORIG-1 |
BENZONATATE |
ACELLA |
|
Approval |
| 01/16/2015 |
CYTARABINE
ANDA #200914 |
SUPPL-1 |
CYTARABINE |
RISING |
Labeling |
Approval |
| 01/16/2015 |
CYTARABINE
ANDA #200914 |
SUPPL-4 |
CYTARABINE |
RISING |
Labeling |
Approval |
| 01/16/2015 |
VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202519 |
SUPPL-3 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/16/2015 |
VALSARTAN AND HYDROCHLOROTHIAZIDE
ANDA #202519 |
SUPPL-4 |
HYDROCHLOROTHIAZIDE; VALSARTAN |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
| 01/17/2015 |
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071062 |
SUPPL-23 |
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE |
FOSUN PHARMA |
Labeling |
Approval |
| 01/17/2015 |
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071063 |
SUPPL-23 |
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE |
FOSUN PHARMA |
Labeling |
Approval |
| 01/17/2015 |
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071064 |
SUPPL-18 |
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE |
FOSUN PHARMA |
Labeling |
Approval |
| 01/17/2015 |
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071862 |
SUPPL-17 |
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE |
FOSUN PHARMA |
Labeling |
Approval |
| 01/17/2015 |
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
ANDA #071863 |
SUPPL-17 |
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE |
FOSUN PHARMA |
Labeling |
Approval |
| 01/17/2015 |
LEVETIRACETAM
ANDA #091285 |
SUPPL-1 |
LEVETIRACETAM |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 01/17/2015 |
LEVETIRACETAM
ANDA #091285 |
SUPPL-2 |
LEVETIRACETAM |
SUN PHARM INDUSTRIES |
Labeling |
Approval |
| 01/17/2015 |
OLANZAPINE
ANDA #091415 |
SUPPL-4 |
OLANZAPINE |
TORRENT |
Labeling |
Approval |
| 01/17/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #202599 |
SUPPL-3 |
ONDANSETRON HYDROCHLORIDE |
EUGIA PHARMA |
Labeling |
Approval |
| 01/17/2015 |
ONDANSETRON HYDROCHLORIDE
ANDA #202599 |
SUPPL-5 |
ONDANSETRON HYDROCHLORIDE |
EUGIA PHARMA |
Labeling |
Approval |
| 01/19/2015 |
PAROXETINE HYDROCHLORIDE
ANDA #077395 |
SUPPL-10 |
PAROXETINE HYDROCHLORIDE |
APOTEX INC |
Labeling |
Approval |
| 01/19/2015 |
PAROXETINE HYDROCHLORIDE
ANDA #077395 |
SUPPL-11 |
PAROXETINE HYDROCHLORIDE |
APOTEX INC |
Labeling |
Approval |
| 01/19/2015 |
PAROXETINE HYDROCHLORIDE
ANDA #077584 |
SUPPL-27 |
PAROXETINE HYDROCHLORIDE |
ZYDUS PHARMS USA |
Labeling |
Approval |
| 01/20/2015 |
BETAMETHASONE VALERATE
NDA #018865 |
SUPPL-13 |
BETAMETHASONE VALERATE |
FOUGERA PHARMS INC |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
FENTANYL CITRATE
NDA #019101 |
SUPPL-41 |
FENTANYL CITRATE |
HIKMA |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
SULFAMYLON
NDA #019832 |
SUPPL-14 |
MAFENIDE ACETATE |
MYLAN INSTITUTIONAL |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
ZYRTEC ALLERGY
NDA #019835 |
SUPPL-35 |
CETIRIZINE HYDROCHLORIDE |
J AND J CONSUMER INC |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
ZYRTEC HIVES RELIEF
NDA #019835 |
SUPPL-35 |
CETIRIZINE HYDROCHLORIDE |
J AND J CONSUMER INC |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
TRI-LUMA
NDA #021112 |
SUPPL-11 |
FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN |
GALDERMA LABS LP |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
ATNAA
NDA #021175 |
SUPPL-25 |
ATROPINE; PRALIDOXIME CHLORIDE |
US ARMY |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
MENOPUR
BLA #021663 |
SUPPL-21 |
MENOTROPINS (FSH;LH) |
FERRING |
|
Approval |
| 01/20/2015 |
ELOXATIN
NDA #021759 |
SUPPL-18 |
OXALIPLATIN |
SANOFI AVENTIS US |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
NUEDEXTA
NDA #021879 |
SUPPL-5 |
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE |
AVANIR PHARMS |
Labeling |
Approval |
| 01/20/2015 |
IXEMPRA KIT
NDA #022065 |
SUPPL-8 |
IXABEPILONE |
R-PHARM US LLC |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
COARTEM
NDA #022268 |
SUPPL-11 |
ARTEMETHER; LUMEFANTRINE |
NOVARTIS |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
CONZIP
NDA #022370 |
SUPPL-11 |
TRAMADOL HYDROCHLORIDE |
CIPHER PHARMS INC |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
TRELSTAR
NDA #022437 |
SUPPL-10 |
TRIPTORELIN PAMOATE |
VERITY |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
HYDROXYCHLOROQUINE SULFATE
ANDA #040274 |
SUPPL-10 |
HYDROXYCHLOROQUINE SULFATE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 01/20/2015 |
EVOCLIN
NDA #050801 |
SUPPL-16 |
CLINDAMYCIN PHOSPHATE |
NORVIUM BIOSCIENCE |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
CYCLOSPORINE
ANDA #065044 |
SUPPL-17 |
CYCLOSPORINE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 01/20/2015 |
CYCLOSPORINE
ANDA #065054 |
SUPPL-19 |
CYCLOSPORINE |
DR REDDYS LABS SA |
Labeling |
Approval |
| 01/20/2015 |
EPITOL
ANDA #070541 |
SUPPL-57 |
CARBAMAZEPINE |
TEVA |
Labeling |
Approval |
| 01/20/2015 |
EPITOL
ANDA #070541 |
SUPPL-58 |
CARBAMAZEPINE |
TEVA |
Labeling |
Approval |
| 01/20/2015 |
CAPTOPRIL
ANDA #074322 |
SUPPL-21 |
CAPTOPRIL |
TEVA |
Labeling |
Approval |
| 01/20/2015 |
CAPTOPRIL
ANDA #074532 |
SUPPL-7 |
CAPTOPRIL |
WOCKHARDT |
Labeling |
Approval |
| 01/20/2015 |
CAPTOPRIL
ANDA #074737 |
SUPPL-8 |
CAPTOPRIL |
COREPHARMA |
Labeling |
Approval |
| 01/20/2015 |
HYDROXYUREA
ANDA #075340 |
SUPPL-11 |
HYDROXYUREA |
ENDO OPERATIONS |
Labeling |
Approval |
| 01/20/2015 |
NORTREL 7/7/7
ANDA #075478 |
SUPPL-15 |
ETHINYL ESTRADIOL; NORETHINDRONE |
BARR |
Labeling |
Approval |
| 01/20/2015 |
CARBAMAZEPINE
ANDA #075712 |
SUPPL-26 |
CARBAMAZEPINE |
TORRENT PHARMS |
Labeling |
Approval |
| 01/20/2015 |
CARBAMAZEPINE
ANDA #075712 |
SUPPL-27 |
CARBAMAZEPINE |
TORRENT PHARMS |
Labeling |
Approval |
| 01/20/2015 |
ALENDRONATE SODIUM
ANDA #075871 |
SUPPL-1 |
ALENDRONATE SODIUM |
CHARTWELL RX |
Labeling |
Approval |
| 01/20/2015 |
MIRTAZAPINE
ANDA #076219 |
SUPPL-23 |
MIRTAZAPINE |
CHARTWELL RX |
Labeling |
Approval |
| 01/20/2015 |
OLANZAPINE
ANDA #076255 |
SUPPL-1 |
OLANZAPINE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 01/20/2015 |
OLANZAPINE
ANDA #076255 |
SUPPL-2 |
OLANZAPINE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 01/20/2015 |
OLANZAPINE
ANDA #076255 |
SUPPL-3 |
OLANZAPINE |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 01/20/2015 |
CARBAMAZEPINE
ANDA #077272 |
SUPPL-15 |
CARBAMAZEPINE |
TORRENT PHARMS |
Labeling |
Approval |
| 01/20/2015 |
CARBAMAZEPINE
ANDA #077272 |
SUPPL-16 |
CARBAMAZEPINE |
TORRENT PHARMS |
Labeling |
Approval |
| 01/20/2015 |
NEVIRAPINE
ANDA #077521 |
SUPPL-15 |
NEVIRAPINE |
AUROBINDO |
Labeling |
Approval |
| 01/20/2015 |
NEVIRAPINE
ANDA #077521 |
SUPPL-16 |
NEVIRAPINE |
AUROBINDO |
Labeling |
Approval |
| 01/20/2015 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077548 |
SUPPL-9 |
ONDANSETRON HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
| 01/20/2015 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077551 |
SUPPL-6 |
ONDANSETRON HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 01/20/2015 |
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
ANDA #077551 |
SUPPL-7 |
ONDANSETRON HYDROCHLORIDE |
SANDOZ |
Labeling |
Approval |
| 01/20/2015 |
OXCARBAZEPINE
ANDA #077794 |
SUPPL-7 |
OXCARBAZEPINE |
SUN PHARM INDS |
Labeling |
Approval |
| 01/20/2015 |
OXCARBAZEPINE
ANDA #077794 |
SUPPL-8 |
OXCARBAZEPINE |
SUN PHARM INDS |
Labeling |
Approval |
| 01/20/2015 |
OXCARBAZEPINE
ANDA #077802 |
SUPPL-8 |
OXCARBAZEPINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/20/2015 |
OXCARBAZEPINE
ANDA #077802 |
SUPPL-11 |
OXCARBAZEPINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
| 01/20/2015 |
NEVIRAPINE
ANDA #077956 |
SUPPL-16 |
NEVIRAPINE |
CIPLA |
Labeling |
Approval |
| 01/20/2015 |
NEVIRAPINE
ANDA #077956 |
SUPPL-20 |
NEVIRAPINE |
CIPLA |
Labeling |
Approval |
| 01/20/2015 |
SERTRALINE HYDROCHLORIDE
ANDA #077977 |
SUPPL-11 |
SERTRALINE HYDROCHLORIDE |
SUN PHARM INDS LTD |
Labeling |
Approval |
| 01/20/2015 |
OXCARBAZEPINE
ANDA #078069 |
SUPPL-4 |
OXCARBAZEPINE |
BRECKENRIDGE PHARM |
Labeling |
Approval |
| 01/20/2015 |
OXCARBAZEPINE
ANDA #078069 |
SUPPL-6 |
OXCARBAZEPINE |
BRECKENRIDGE PHARM |
Labeling |
Approval |
| 01/20/2015 |
CARBAMAZEPINE
ANDA #078592 |
SUPPL-2 |
CARBAMAZEPINE |
TEVA PHARMS |
Labeling |
Approval |
| 01/20/2015 |
CARBAMAZEPINE
ANDA #078592 |
SUPPL-3 |
CARBAMAZEPINE |
TEVA PHARMS |
Labeling |
Approval |
| 01/20/2015 |
NEVIRAPINE
ANDA #078644 |
SUPPL-2 |
NEVIRAPINE |
PRINSTON INC |
Labeling |
Approval |
| 01/20/2015 |
OXCARBAZEPINE
ANDA #090239 |
SUPPL-1 |
OXCARBAZEPINE |
JUBILANT CADISTA |
Labeling |
Approval |
| 01/20/2015 |
OXCARBAZEPINE
ANDA #090239 |
SUPPL-4 |
OXCARBAZEPINE |
JUBILANT CADISTA |
Labeling |
Approval |
| 01/20/2015 |
IBUPROFEN AND DIPHENHYDRAMINE CITRATE
ANDA #090619 |
SUPPL-3 |
DIPHENHYDRAMINE CITRATE; IBUPROFEN |
DR REDDYS LABS LTD |
Labeling |
Approval |
| 01/20/2015 |
NIFEDIPINE
ANDA #090649 |
SUPPL-8 |
NIFEDIPINE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 01/20/2015 |
NIFEDIPINE
ANDA #090649 |
SUPPL-11 |
NIFEDIPINE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 01/20/2015 |
DOXYCYCLINE
ANDA #091605 |
SUPPL-2 |
DOXYCYCLINE |
HERITAGE |
Labeling |
Approval |
| 01/20/2015 |
ZYTIGA
NDA #202379 |
SUPPL-14 |
ABIRATERONE ACETATE |
JANSSEN BIOTECH |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
NEVIRAPINE
ANDA #203021 |
SUPPL-2 |
NEVIRAPINE |
APOTEX INC |
Labeling |
Approval |
| 01/20/2015 |
NEVIRAPINE
ANDA #203176 |
SUPPL-3 |
NEVIRAPINE |
TECH ORGANIZED |
Labeling |
Approval |
| 01/20/2015 |
ICLUSIG
NDA #203469 |
SUPPL-13 |
PONATINIB HYDROCHLORIDE |
TAKEDA PHARMS USA |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
KERYDIN
NDA #204427 |
SUPPL-1 |
TAVABOROLE |
ANACOR PHARMS INC |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
TRINTELLIX
NDA #204447 |
SUPPL-2 |
VORTIOXETINE HYDROBROMIDE |
TAKEDA PHARMS USA |
Manufacturing (CMC) |
Approval |
| 01/20/2015 |
VARITHENA
NDA #205098 |
SUPPL-6 |
POLIDOCANOL |
PROVENSIS |
Manufacturing (CMC) |
Approval |
| 01/21/2015 |
M.V.I. ADULT
NDA #021625 |
SUPPL-18 |
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K |
HOSPIRA |
Labeling |
Approval |
| 01/21/2015 |
M.V.I. ADULT (PHARMACY BULK PACKAGE)
NDA #021643 |
SUPPL-15 |
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K |
HOSPIRA |
Labeling |
Approval |
| 01/21/2015 |
TIMOLOL MALEATE
ANDA #075411 |
SUPPL-21 |
TIMOLOL MALEATE |
APOTEX INC |
Labeling |
Approval |
| 01/21/2015 |
AMLODIPINE BESYLATE
ANDA #078573 |
SUPPL-5 |
AMLODIPINE BESYLATE |
TORRENT PHARMS |
Labeling |
Approval |
| 01/21/2015 |
COSENTYX
BLA #125504 |
ORIG-1 |
SECUKINUMAB |
NOVARTIS PHARMS CORP |
|
Approval |
| 01/21/2015 |
RALOXIFENE HYDROCHLORIDE
ANDA #200825 |
ORIG-1 |
RALOXIFENE HYDROCHLORIDE |
WATSON LABS INC |
|
Approval |
| 01/21/2015 |
PRESTALIA
NDA #205003 |
ORIG-1 |
AMLODIPINE BESYLATE; PERINDOPRIL ARGININE |
ADHERA |
Type 4 - New Combination |
Approval |
| 01/22/2015 |
KINEVAC
NDA #017697 |
SUPPL-24 |
SINCALIDE |
BRACCO |
Manufacturing (CMC) |
Approval |
| 01/22/2015 |
XOPENEX
NDA #020837 |
SUPPL-41 |
LEVALBUTEROL HYDROCHLORIDE |
HIKMA |
Efficacy |
Approval |
| 01/22/2015 |
DOXIL (LIPOSOMAL)
NDA #050718 |
SUPPL-46 |
DOXORUBICIN HYDROCHLORIDE |
BAXTER HLTHCARE CORP |
Manufacturing (CMC) |
Approval |
| 01/22/2015 |
PROPRANOLOL HYDROCHLORIDE
ANDA #071972 |
SUPPL-32 |
PROPRANOLOL HYDROCHLORIDE |
IMPAX LABS INC |
Manufacturing (CMC) |
Approval |
| 01/22/2015 |
PROPRANOLOL HYDROCHLORIDE
ANDA #071976 |
SUPPL-32 |
PROPRANOLOL HYDROCHLORIDE |
IMPAX LABS INC |
Manufacturing (CMC) |
Approval |
| 01/22/2015 |
GABAPENTIN
ANDA #078974 |
SUPPL-2 |
GABAPENTIN |
MISSION PHARMACAL |
Manufacturing (CMC) |
Approval |
| 01/22/2015 |
ALA-SCALP
ANDA #083231 |
SUPPL-7 |
HYDROCORTISONE |
LEGACY PHARMA |
Labeling |
Approval |
| 01/22/2015 |
CALCIUM ACETATE
ANDA #202885 |
ORIG-1 |
CALCIUM ACETATE |
HERITAGE PHARMS INC |
|
Approval |
| 01/23/2015 |
NITROLINGUAL
NDA #018705 |
SUPPL-19 |
NITROGLYCERIN |
POHL BOSKAMP |
Labeling |
Approval |
| 01/23/2015 |
NITROLINGUAL PUMPSPRAY
NDA #018705 |
SUPPL-19 |
NITROGLYCERIN |
POHL BOSKAMP |
Labeling |
Approval |
| 01/23/2015 |
FLONASE
NDA #020121 |
SUPPL-44 |
FLUTICASONE PROPIONATE |
HALEON US HOLDINGS |
Labeling |
Approval |
| 01/23/2015 |
DEPO-PROVERA
NDA #020246 |
SUPPL-54 |
MEDROXYPROGESTERONE ACETATE |
PFIZER |
Labeling |
Approval |
| 01/23/2015 |
PLETAL
NDA #020863 |
SUPPL-22 |
CILOSTAZOL |
OTSUKA |
Labeling |
Approval |
| 01/23/2015 |
NOVOLOG
BLA #020986 |
SUPPL-80 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/23/2015 |
NOVOLOG FLEXPEN
BLA #020986 |
SUPPL-80 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/23/2015 |
NOVOLOG FLEXTOUCH
BLA #020986 |
SUPPL-80 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/23/2015 |
NOVOLOG INNOLET
BLA #020986 |
SUPPL-80 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/23/2015 |
NOVOLOG PENFILL
BLA #020986 |
SUPPL-80 |
INSULIN ASPART RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/23/2015 |
NORDITROPIN
BLA #021148 |
SUPPL-42 |
SOMATROPIN |
NOVO NORDISK INC |
|
Approval |
| 01/23/2015 |
NORDITROPIN FLEXPRO
BLA #021148 |
SUPPL-42 |
SOMATROPIN |
NOVO NORDISK INC |
|
Approval |
| 01/23/2015 |
NORDITROPIN NORDIFLEX
BLA #021148 |
SUPPL-42 |
SOMATROPIN |
NOVO NORDISK INC |
|
Approval |
| 01/23/2015 |
LEVEMIR
BLA #021536 |
SUPPL-50 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/23/2015 |
LEVEMIR FLEXPEN
BLA #021536 |
SUPPL-50 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/23/2015 |
LEVEMIR FLEXTOUCH
BLA #021536 |
SUPPL-50 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/23/2015 |
LEVEMIR INNOLET
BLA #021536 |
SUPPL-50 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/23/2015 |
LEVEMIR PENFILL
BLA #021536 |
SUPPL-50 |
INSULIN DETEMIR RECOMBINANT |
NOVO NORDISK INC |
|
Approval |
| 01/23/2015 |
DEPO-SUBQ PROVERA 104
NDA #021583 |
SUPPL-26 |
MEDROXYPROGESTERONE ACETATE |
PFIZER |
Labeling |
Approval |
| 01/23/2015 |
ATRIPLA
NDA #021937 |
SUPPL-34 |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
GILEAD SCIENCES |
Labeling |
Approval |
| 01/23/2015 |
AFINITOR
NDA #022334 |
SUPPL-29 |
EVEROLIMUS |
NOVARTIS |
Labeling |
Approval |
| 01/23/2015 |
ENALAPRIL MALEATE
ANDA #075480 |
SUPPL-13 |
ENALAPRIL MALEATE |
AUROBINDO PHARMA USA |
Labeling |
Approval |
| 01/23/2015 |
DESMOPRESSIN ACETATE
ANDA #077414 |
SUPPL-8 |
DESMOPRESSIN ACETATE |
APOTEX INC |
Labeling |
Approval |
| 01/23/2015 |
NATPARA
BLA #125511 |
ORIG-1 |
PARATHYROID HORMONE |
NPS PHARMS INC |
|
Approval |
| 01/23/2015 |
ZYTIGA
NDA #202379 |
SUPPL-15 |
ABIRATERONE ACETATE |
JANSSEN BIOTECH |
Labeling |
Approval |
| 01/23/2015 |
AFINITOR DISPERZ
NDA #203985 |
SUPPL-8 |
EVEROLIMUS |
NOVARTIS PHARM |
Labeling |
Approval |
| 01/23/2015 |
TRIFERIC
NDA #206317 |
ORIG-1 |
FERRIC PYROPHOSPHATE CITRATE |
ROCKWELL MEDICAL INC |
Type 5 - New Formulation or New Manufacturer |
Approval |
| 01/24/2015 |
LEVETIRACETAM
ANDA #079042 |
SUPPL-2 |
LEVETIRACETAM |
INGENUS PHARMS LLC |
Labeling |
Approval |
| 01/24/2015 |
RAMIPRIL
ANDA #079116 |
SUPPL-3 |
RAMIPRIL |
COREPHARMA |
Labeling |
Approval |
| 01/24/2015 |
RAMIPRIL
ANDA #079116 |
SUPPL-4 |
RAMIPRIL |
COREPHARMA |
Labeling |
Approval |
| 01/24/2015 |
RAMIPRIL
ANDA #079116 |
SUPPL-5 |
RAMIPRIL |
COREPHARMA |
Labeling |
Approval |
| 01/24/2015 |
RAMIPRIL
ANDA #079116 |
SUPPL-6 |
RAMIPRIL |
COREPHARMA |
Labeling |
Approval |
| 01/24/2015 |
RAMIPRIL
ANDA #079116 |
SUPPL-7 |
RAMIPRIL |
COREPHARMA |
Labeling |
Approval |
| 01/24/2015 |
HYDROXYZINE PAMOATE
ANDA #086183 |
SUPPL-37 |
HYDROXYZINE PAMOATE |
SANDOZ |
Labeling |
Approval |
| 01/24/2015 |
HYDROXYZINE PAMOATE
ANDA #087479 |
SUPPL-39 |
HYDROXYZINE PAMOATE |
SANDOZ |
Labeling |
Approval |
| 01/24/2015 |
HYDROXYZINE PAMOATE
ANDA #088487 |
SUPPL-50 |
HYDROXYZINE PAMOATE |
BARR |
Labeling |
Approval |
| 01/24/2015 |
HYDROXYZINE PAMOATE
ANDA #088488 |
SUPPL-48 |
HYDROXYZINE PAMOATE |
BARR |
Labeling |
Approval |
| 01/24/2015 |
HYDROXYZINE PAMOATE
ANDA #088496 |
SUPPL-48 |
HYDROXYZINE PAMOATE |
BARR |
Labeling |
Approval |
| 01/24/2015 |
HYDROXYZINE PAMOATE
ANDA #201507 |
SUPPL-3 |
HYDROXYZINE PAMOATE |
HERITAGE PHARMA |
Labeling |
Approval |
| 01/25/2015 |
AMINO ACIDS
ANDA #091112 |
SUPPL-2 |
AMINO ACIDS |
B BRAUN |
Labeling |
Approval |
| 01/26/2015 |
DESOXYN
NDA #005378 |
SUPPL-29 |
METHAMPHETAMINE HYDROCHLORIDE |
AJENAT PHARMS |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
ORAP
NDA #017473 |
SUPPL-48 |
PIMOZIDE |
TEVA |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
LITHOSTAT
NDA #018749 |
SUPPL-9 |
ACETOHYDROXAMIC ACID |
MISSION PHARMA |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #018803 |
SUPPL-24 |
SODIUM CHLORIDE |
HOSPIRA |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
BREVIBLOC
NDA #019386 |
SUPPL-47 |
ESMOLOL HYDROCHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
NDA #019386 |
SUPPL-47 |
ESMOLOL HYDROCHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
BREVIBLOC IN PLASTIC CONTAINER
NDA #019386 |
SUPPL-47 |
ESMOLOL HYDROCHLORIDE |
BAXTER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
LOTENSIN
NDA #019851 |
SUPPL-47 |
BENAZEPRIL HYDROCHLORIDE |
VALIDUS PHARMS |
Labeling |
Approval |
| 01/26/2015 |
DILAUDID
NDA #019892 |
SUPPL-25 |
HYDROMORPHONE HYDROCHLORIDE |
RHODES PHARMS |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
OXISTAT
NDA #020209 |
SUPPL-8 |
OXICONAZOLE NITRATE |
ANI PHARMS |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
HUMALOG
BLA #020563 |
SUPPL-156 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
| 01/26/2015 |
HUMALOG KWIKPEN
BLA #020563 |
SUPPL-156 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
| 01/26/2015 |
HUMALOG PEN
BLA #020563 |
SUPPL-156 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
| 01/26/2015 |
HUMALOG TEMPO PEN
BLA #020563 |
SUPPL-156 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
| 01/26/2015 |
COPAXONE
NDA #020622 |
SUPPL-92 |
GLATIRAMER ACETATE |
TEVA PHARMS USA |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
VIAGRA
NDA #020895 |
SUPPL-43 |
SILDENAFIL CITRATE |
VIATRIS |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
SEPTOCAINE
NDA #020971 |
SUPPL-34 |
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
DEPROCO |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
ANGELIQ
NDA #021355 |
SUPPL-5 |
DROSPIRENONE; ESTRADIOL |
BAYER HLTHCARE |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
VIVITROL
NDA #021897 |
SUPPL-28 |
NALTREXONE |
ALKERMES |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
SPRYCEL
NDA #021986 |
SUPPL-15 |
DASATINIB |
BRISTOL MYERS SQUIBB |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
SEROQUEL XR
NDA #022047 |
SUPPL-36 |
QUETIAPINE FUMARATE |
ASTRAZENECA |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
ORAVERSE
NDA #022159 |
SUPPL-9 |
PHENTOLAMINE MESYLATE |
SEPTODONT HOLDING |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
ORAVERSE
NDA #022159 |
SUPPL-10 |
PHENTOLAMINE MESYLATE |
SEPTODONT HOLDING |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
TRELSTAR
NDA #022437 |
SUPPL-11 |
TRIPTORELIN PAMOATE |
VERITY |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
ESOMEPRAZOLE MAGNESIUM
ANDA #078003 |
ORIG-1 |
ESOMEPRAZOLE MAGNESIUM |
IVAX SUB TEVA PHARMS |
|
Approval |
| 01/26/2015 |
NITHIODOTE
NDA #201444 |
SUPPL-15 |
SODIUM NITRITE; SODIUM THIOSULFATE |
HOPE PHARMS |
Manufacturing (CMC) |
Approval |
| 01/26/2015 |
OXAYDO
NDA #202080 |
SUPPL-3 |
OXYCODONE HYDROCHLORIDE |
ZYLA |
Labeling |
Approval |
| 01/26/2015 |
XARTEMIS XR
NDA #204031 |
SUPPL-2 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
MALLINCKRODT INC |
Manufacturing (CMC) |
Approval |
| 01/27/2015 |
FRAGMIN
NDA #020287 |
SUPPL-62 |
DALTEPARIN SODIUM |
PFIZER |
Labeling |
Approval |
| 01/27/2015 |
ZORTRESS
NDA #021560 |
SUPPL-11 |
EVEROLIMUS |
NOVARTIS |
Labeling |
Approval |
| 01/27/2015 |
TASIGNA
NDA #022068 |
SUPPL-20 |
NILOTINIB HYDROCHLORIDE |
NOVARTIS |
Efficacy |
Approval |
| 01/27/2015 |
CALDOLOR
NDA #022348 |
SUPPL-3 |
IBUPROFEN |
CUMBERLAND PHARMS |
Labeling |
Approval |
| 01/27/2015 |
AMLODIPINE BESYLATE
ANDA #078552 |
SUPPL-3 |
AMLODIPINE BESYLATE |
EPIC PHARMA LLC |
Manufacturing (CMC) |
Approval |
| 01/27/2015 |
VALACYCLOVIR HYDROCHLORIDE
ANDA #090682 |
SUPPL-9 |
VALACYCLOVIR HYDROCHLORIDE |
AUROBINDO PHARMA |
Manufacturing (CMC) |
Approval |
| 01/27/2015 |
HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE
ANDA #206438 |
ORIG-1 |
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE |
TRIS PHARMA INC |
|
Approval |
| 01/28/2015 |
KALETRA
NDA #021251 |
SUPPL-47 |
LOPINAVIR; RITONAVIR |
ABBVIE |
Efficacy |
Approval |
| 01/28/2015 |
KALETRA
NDA #021906 |
SUPPL-40 |
LOPINAVIR; RITONAVIR |
ABBVIE |
Efficacy |
Approval |
| 01/28/2015 |
VANCOMYCIN HYDROCHLORIDE
ANDA #090439 |
ORIG-1 |
VANCOMYCIN HYDROCHLORIDE |
LUPIN LTD |
|
Approval |
| 01/28/2015 |
OPANA ER
NDA #201655 |
SUPPL-16 |
OXYMORPHONE HYDROCHLORIDE |
ENDO PHARMS |
REMS |
Approval |
| 01/29/2015 |
SAVELLA
NDA #022256 |
SUPPL-19 |
MILNACIPRAN HYDROCHLORIDE |
ABBVIE |
Labeling |
Approval |
| 01/29/2015 |
DEXTROAMPHETAMINE SULFATE
ANDA #040361 |
SUPPL-18 |
DEXTROAMPHETAMINE SULFATE |
BARR |
Labeling |
Approval |
| 01/29/2015 |
DEXTROAMPHETAMINE SULFATE
ANDA #040436 |
SUPPL-8 |
DEXTROAMPHETAMINE SULFATE |
SPECGX LLC |
Labeling |
Approval |
| 01/29/2015 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040439 |
SUPPL-15 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
SANDOZ |
Labeling |
Approval |
| 01/29/2015 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040439 |
SUPPL-17 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
SANDOZ |
Labeling |
Approval |
| 01/29/2015 |
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA #040440 |
SUPPL-11 |
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
SPECGX LLC |
Labeling |
Approval |
| 01/29/2015 |
FLUCONAZOLE
ANDA #077731 |
SUPPL-8 |
FLUCONAZOLE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/29/2015 |
FLUCONAZOLE
ANDA #077731 |
SUPPL-9 |
FLUCONAZOLE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/29/2015 |
FLUCONAZOLE
ANDA #077731 |
SUPPL-11 |
FLUCONAZOLE |
AUROBINDO PHARMA |
Labeling |
Approval |
| 01/29/2015 |
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA #090818 |
ORIG-1 |
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
SUN PHARM |
|
Approval |
| 01/29/2015 |
ZORVOLEX
NDA #204592 |
SUPPL-6 |
DICLOFENAC |
ZYLA |
Manufacturing (CMC) |
Approval |
| 01/29/2015 |
PREZCOBIX
NDA #205395 |
ORIG-1 |
COBICISTAT; DARUNAVIR |
JANSSEN PRODS |
Type 4 - New Combination |
Approval |
| 01/29/2015 |
IMBRUVICA
NDA #205552 |
SUPPL-2 |
IBRUTINIB |
PHARMACYCLICS LLC |
Efficacy |
Approval |
| 01/29/2015 |
EVOTAZ
NDA #206353 |
ORIG-1 |
ATAZANAVIR SULFATE; COBICISTAT |
BRISTOL |
Type 4 - New Combination |
Approval |
| 01/30/2015 |
MIVACRON
NDA #020098 |
SUPPL-18 |
MIVACURIUM CHLORIDE |
ABBVIE |
Manufacturing (CMC) |
Approval |
| 01/30/2015 |
MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER
NDA #020098 |
SUPPL-18 |
MIVACURIUM CHLORIDE |
ABBVIE |
Manufacturing (CMC) |
Approval |
| 01/30/2015 |
DEPO-PROVERA
NDA #020246 |
SUPPL-53 |
MEDROXYPROGESTERONE ACETATE |
PFIZER |
Labeling |
Approval |
| 01/30/2015 |
ZANTAC 75
NDA #020520 |
SUPPL-28 |
RANITIDINE HYDROCHLORIDE |
CHATTEM SANOFI |
Labeling |
Approval |
| 01/30/2015 |
ABREVA
NDA #020941 |
SUPPL-11 |
DOCOSANOL |
HALEON US HOLDINGS |
Labeling |
Approval |
| 01/30/2015 |
CIPRO XR
NDA #021473 |
SUPPL-36 |
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE |
BAYER HLTHCARE |
Labeling |
Approval |
| 01/30/2015 |
DEPO-SUBQ PROVERA 104
NDA #021583 |
SUPPL-25 |
MEDROXYPROGESTERONE ACETATE |
PFIZER |
Labeling |
Approval |
| 01/30/2015 |
GLEEVEC
NDA #021588 |
SUPPL-42 |
IMATINIB MESYLATE |
NOVARTIS |
Efficacy |
Approval |
| 01/30/2015 |
RECLAST
NDA #021817 |
SUPPL-20 |
ZOLEDRONIC ACID |
SANDOZ |
Labeling |
Approval |
| 01/30/2015 |
VYVANSE
NDA #021977 |
SUPPL-36 |
LISDEXAMFETAMINE DIMESYLATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
| 01/30/2015 |
VYVANSE
NDA #021977 |
SUPPL-37 |
LISDEXAMFETAMINE DIMESYLATE |
TAKEDA PHARMS USA |
Efficacy |
Approval |
| 01/30/2015 |
OMEPRAZOLE
ANDA #075410 |
SUPPL-43 |
OMEPRAZOLE |
LANNETT CO INC |
Manufacturing (CMC) |
Approval |
| 01/30/2015 |
MITOXANTRONE HYDROCHLORIDE
ANDA #076871 |
SUPPL-12 |
MITOXANTRONE HYDROCHLORIDE |
HOSPIRA |
Manufacturing (CMC) |
Approval |
| 01/30/2015 |
SCOPOLAMINE
ANDA #078830 |
ORIG-1 |
SCOPOLAMINE |
PADAGIS US |
|
Approval |
| 01/30/2015 |
MEMANTINE HYDROCHLORIDE
ANDA #079225 |
ORIG-1 |
MEMANTINE HYDROCHLORIDE |
RISING |
|
Approval |
| 01/30/2015 |
DEXTROAMPHETAMINE SULFATE
ANDA #090533 |
SUPPL-4 |
DEXTROAMPHETAMINE SULFATE |
AZURITY |
Labeling |
Approval |
| 01/30/2015 |
ESZOPICLONE
ANDA #091103 |
SUPPL-1 |
ESZOPICLONE |
SUN PHARM |
Labeling |
Approval |
| 01/30/2015 |
ESZOPICLONE
ANDA #091153 |
SUPPL-1 |
ESZOPICLONE |
HIKMA |
Labeling |
Approval |
| 01/30/2015 |
ESZOPICLONE
ANDA #091165 |
SUPPL-1 |
ESZOPICLONE |
CHARTWELL RX |
Labeling |
Approval |
| 01/30/2015 |
ZOHYDRO ER
NDA #202880 |
SUPPL-3 |
HYDROCODONE BITARTRATE |
RECRO GAINESVILLE |
Manufacturing (CMC) |
Approval |
| 01/30/2015 |
ESZOPICLONE
ANDA #202929 |
ORIG-1 |
ESZOPICLONE |
MACLEODS PHARMS LTD |
|
Approval |
| 01/30/2015 |
DONEPEZIL HYDROCHLORIDE
ANDA #203034 |
ORIG-1 |
DONEPEZIL HYDROCHLORIDE |
HETERO LABS LTD V |
|
Approval |
| 01/30/2015 |
GLYXAMBI
NDA #206073 |
ORIG-1 |
EMPAGLIFLOZIN; LINAGLIPTIN |
BOEHRINGER INGELHEIM |
Type 4 - New Combination |
Approval |
| 01/30/2015 |
PATADAY ONCE DAILY RELIEF
NDA #206276 |
ORIG-1 |
OLOPATADINE HYDROCHLORIDE |
ALCON LABS INC |
Type 5 - New Formulation or New Manufacturer |
Approval |
