11/01/2018 |
HUMALOG BLA #020563 |
SUPPL-191 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/01/2018 |
HUMALOG KWIKPEN BLA #020563 |
SUPPL-191 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/01/2018 |
HUMALOG PEN BLA #020563 |
SUPPL-191 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/01/2018 |
HUMALOG TEMPO PEN BLA #020563 |
SUPPL-191 |
INSULIN LISPRO RECOMBINANT |
LILLY |
|
Approval |
11/01/2018 |
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PRISMASOL BGK 4/0 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PRISMASOL BK 0/0 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER NDA #021703 |
SUPPL-20 |
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
LIDOCAINE HYDROCHLORIDE ANDA #040014 |
SUPPL-7 |
LIDOCAINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
11/01/2018 |
LIDOCAINE ANDA #040911 |
SUPPL-5 |
LIDOCAINE |
SEPTODONT INC |
Labeling |
Approval |
11/01/2018 |
NICOTINE POLACRILEX ANDA #203690 |
SUPPL-17 |
NICOTINE POLACRILEX |
PPI-DAC |
Manufacturing (CMC) |
Approval |
11/01/2018 |
NICOTINE POLACRILEX ANDA #203690 |
SUPPL-18 |
NICOTINE POLACRILEX |
PPI-DAC |
Manufacturing (CMC) |
Approval |
11/01/2018 |
PROBUPHINE NDA #204442 |
SUPPL-7 |
BUPRENORPHINE HYDROCHLORIDE |
REACX PHARMS |
REMS |
Approval |
11/01/2018 |
HUMALOG KWIKPEN BLA #205747 |
SUPPL-18 |
INSULIN LISPRO RECOMBINANT |
ELI LILLY AND CO |
|
Approval |
11/01/2018 |
PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER NDA #207026 |
SUPPL-6 |
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER NDA #207026 |
SUPPL-6 |
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE |
BAXTER HLTHCARE CORP |
Labeling |
Approval |
11/01/2018 |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE ANDA #208430 |
ORIG-1 |
LINAGLIPTIN;METFORMIN HYDROCHLORIDE |
MYLAN PHARMS INC |
|
Tentative Approval |
11/01/2018 |
ADMELOG BLA #209196 |
SUPPL-2 |
INSULIN LISPRO |
SANOFI-AVENTIS US |
|
Approval |
11/01/2018 |
ADMELOG SOLOSTAR BLA #209196 |
SUPPL-2 |
INSULIN LISPRO |
SANOFI-AVENTIS US |
|
Approval |
11/01/2018 |
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE ANDA #209692 |
ORIG-1 |
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
AMNEAL PHARMS |
|
Approval |
11/01/2018 |
DOXERCALCIFEROL ANDA #210801 |
ORIG-1 |
DOXERCALCIFEROL |
LUPIN LTD |
|
Approval |
11/01/2018 |
SYMPAZAN NDA #210833 |
ORIG-1 |
CLOBAZAM |
OTTER PHARMS |
Type 3 - New Dosage Form |
Approval |
11/02/2018 |
XYLOCAINE NDA #006488 |
SUPPL-97 |
LIDOCAINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
11/02/2018 |
XYLOCAINE W/ EPINEPHRINE NDA #006488 |
SUPPL-97 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
11/02/2018 |
XYLOCAINE NDA #008816 |
SUPPL-39 |
LIDOCAINE HYDROCHLORIDE |
EPIC PHARMA LLC |
Labeling |
Approval |
11/02/2018 |
NESACAINE NDA #009435 |
SUPPL-44 |
CHLOROPROCAINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
11/02/2018 |
NESACAINE-MPF NDA #009435 |
SUPPL-44 |
CHLOROPROCAINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
11/02/2018 |
CARBOCAINE NDA #012250 |
SUPPL-37 |
MEPIVACAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
11/02/2018 |
MARCAINE HYDROCHLORIDE NDA #016964 |
SUPPL-77 |
BUPIVACAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
11/02/2018 |
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE NDA #016964 |
SUPPL-77 |
BUPIVACAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
11/02/2018 |
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE NDA #016964 |
SUPPL-77 |
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
HOSPIRA |
Labeling |
Approval |
11/02/2018 |
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE NDA #016964 |
SUPPL-77 |
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
HOSPIRA |
Labeling |
Approval |
11/02/2018 |
BUPIVACAINE HYDROCHLORIDE NDA #018053 |
SUPPL-60 |
BUPIVACAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
11/02/2018 |
SENSORCAINE NDA #018304 |
SUPPL-49 |
BUPIVACAINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
11/02/2018 |
SENSORCAINE NDA #018304 |
SUPPL-49 |
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
FRESENIUS KABI USA |
Labeling |
Approval |
11/02/2018 |
MARCAINE NDA #018692 |
SUPPL-20 |
BUPIVACAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
11/02/2018 |
RYTHMOL NDA #019151 |
SUPPL-15 |
PROPAFENONE HYDROCHLORIDE |
GLAXOSMITHKLINE LLC |
Labeling |
Approval |
11/02/2018 |
EMLA NDA #019941 |
SUPPL-21 |
LIDOCAINE; PRILOCAINE |
TEVA BRANDED PHARM |
Labeling |
Approval |
11/02/2018 |
NAROPIN NDA #020533 |
SUPPL-35 |
ROPIVACAINE HYDROCHLORIDE |
FRESENIUS KABI USA |
Labeling |
Approval |
11/02/2018 |
LIDODERM NDA #020612 |
SUPPL-14 |
LIDOCAINE |
TEIKOKU PHARMA USA |
Labeling |
Approval |
11/02/2018 |
OPTIMARK NDA #020937 |
SUPPL-28 |
GADOVERSETAMIDE |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
11/02/2018 |
SEPTOCAINE NDA #020971 |
SUPPL-42 |
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
DEPROCO |
Labeling |
Approval |
11/02/2018 |
OPTIMARK NDA #020975 |
SUPPL-29 |
GADOVERSETAMIDE |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
11/02/2018 |
OPTIMARK IN PLASTIC CONTAINER NDA #020976 |
SUPPL-30 |
GADOVERSETAMIDE |
LIEBEL-FLARSHEIM |
Labeling |
Approval |
11/02/2018 |
MULTIHANCE NDA #021357 |
SUPPL-18 |
GADOBENATE DIMEGLUMINE |
BRACCO |
Labeling |
Approval |
11/02/2018 |
MULTIHANCE MULTIPACK NDA #021358 |
SUPPL-17 |
GADOBENATE DIMEGLUMINE |
BRACCO |
Labeling |
Approval |
11/02/2018 |
XYLOCAINE DENTAL NDA #021380 |
SUPPL-7 |
LIDOCAINE HYDROCHLORIDE |
DENTSPLY PHARM |
Labeling |
Approval |
11/02/2018 |
XYLOCAINE DENTAL WITH EPINEPHRINE NDA #021381 |
SUPPL-6 |
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE |
DENTSPLY PHARM |
Labeling |
Approval |
11/02/2018 |
CITANEST PLAIN DENTAL NDA #021382 |
SUPPL-8 |
PRILOCAINE HYDROCHLORIDE |
DENTSPLY PHARM |
Labeling |
Approval |
11/02/2018 |
CITANEST FORTE DENTAL NDA #021383 |
SUPPL-11 |
EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE |
DENTSPLY PHARM |
Labeling |
Approval |
11/02/2018 |
RYTHMOL SR NDA #021416 |
SUPPL-15 |
PROPAFENONE HYDROCHLORIDE |
GLAXOSMITHKLINE LLC |
Labeling |
Approval |
11/02/2018 |
ORAQIX NDA #021451 |
SUPPL-14 |
LIDOCAINE; PRILOCAINE |
DENTSPLY PHARM |
Labeling |
Approval |
11/02/2018 |
NAMENDA NDA #021487 |
SUPPL-25 |
MEMANTINE HYDROCHLORIDE |
ABBVIE |
Labeling |
Approval |
11/02/2018 |
PROHANCE MULTIPACK NDA #021489 |
SUPPL-10 |
GADOTERIDOL |
BRACCO |
Labeling |
Approval |
11/02/2018 |
SYNERA NDA #021623 |
SUPPL-24 |
LIDOCAINE; TETRACAINE |
GALEN SPECIALTY |
Labeling |
Approval |
11/02/2018 |
PLIAGLIS NDA #021717 |
SUPPL-11 |
LIDOCAINE; TETRACAINE |
CRESCITA THERAP |
Labeling |
Approval |
11/02/2018 |
BUPIVACAINE HYDROCHLORIDE NDA #022046 |
SUPPL-9 |
BUPIVACAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
11/02/2018 |
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE NDA #022046 |
SUPPL-9 |
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
HOSPIRA |
Labeling |
Approval |
11/02/2018 |
EOVIST NDA #022090 |
SUPPL-16 |
GADOXETATE DISODIUM |
BAYER HLTHCARE |
Labeling |
Approval |
11/02/2018 |
ZINGO NDA #022114 |
SUPPL-4 |
LIDOCAINE HYDROCHLORIDE |
POWDER PHARMS |
Labeling |
Approval |
11/02/2018 |
ORABLOC NDA #022466 |
SUPPL-5 |
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
PIERREL |
Labeling |
Approval |
11/02/2018 |
EXPAREL NDA #022496 |
SUPPL-30 |
BUPIVACAINE |
PACIRA PHARMS INC |
Labeling |
Approval |
11/02/2018 |
LIDOCAINE HYDROCHLORIDE ANDA #040014 |
SUPPL-8 |
LIDOCAINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
11/02/2018 |
LIDOCAINE HYDROCHLORIDE VISCOUS ANDA #040708 |
SUPPL-7 |
LIDOCAINE HYDROCHLORIDE |
CHARTWELL MOLECULAR |
Labeling |
Approval |
11/02/2018 |
MEPIVACAINE HYDROCHLORIDE ANDA #040806 |
SUPPL-5 |
MEPIVACAINE HYDROCHLORIDE |
HOSPIRA INC |
Labeling |
Approval |
11/02/2018 |
LIDOCAINE ANDA #040911 |
SUPPL-7 |
LIDOCAINE |
SEPTODONT INC |
Labeling |
Approval |
11/02/2018 |
ERYTHROMYCIN ETHYLSUCCINATE ANDA #062055 |
SUPPL-34 |
ERYTHROMYCIN ETHYLSUCCINATE |
ANI PHARMS |
Manufacturing (CMC) |
Approval |
11/02/2018 |
ERYTHROMYCIN ETHYLSUCCINATE ANDA #062055 |
SUPPL-35 |
ERYTHROMYCIN ETHYLSUCCINATE |
ANI PHARMS |
Manufacturing (CMC) |
Approval |
11/02/2018 |
QUINAPRIL HYDROCHLORIDE ANDA #076803 |
SUPPL-4 |
QUINAPRIL HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
11/02/2018 |
QUINAPRIL HYDROCHLORIDE ANDA #076803 |
SUPPL-5 |
QUINAPRIL HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
11/02/2018 |
IRBESARTAN ANDA #077159 |
SUPPL-9 |
IRBESARTAN |
TEVA PHARMS |
Labeling |
Approval |
11/02/2018 |
IRBESARTAN ANDA #079213 |
SUPPL-2 |
IRBESARTAN |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
11/02/2018 |
IRBESARTAN ANDA #079213 |
SUPPL-3 |
IRBESARTAN |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
11/02/2018 |
PRILOCAINE HYDROCHLORIDE ANDA #079235 |
SUPPL-5 |
PRILOCAINE HYDROCHLORIDE |
SEPTODONT INC |
Labeling |
Approval |
11/02/2018 |
LIDOCAINE ANDA #080198 |
SUPPL-30 |
LIDOCAINE |
FOUGERA PHARMS INC |
Labeling |
Approval |
11/02/2018 |
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5% ANDA #083914 |
SUPPL-40 |
LIDOCAINE HYDROCHLORIDE |
HOSPIRA |
Labeling |
Approval |
11/02/2018 |
LIDOCAINE HYDROCHLORIDE VISCOUS ANDA #086578 |
SUPPL-40 |
LIDOCAINE HYDROCHLORIDE |
ACTAVIS MID ATLANTIC |
Labeling |
Approval |
11/02/2018 |
LIDOCAINE ANDA #086724 |
SUPPL-33 |
LIDOCAINE |
TARO |
Labeling |
Approval |
11/02/2018 |
LIDOCAINE ANDA #086724 |
SUPPL-35 |
LIDOCAINE |
TARO |
Labeling |
Approval |
11/02/2018 |
LIDOCAINE HYDROCHLORIDE ANDA #087872 |
SUPPL-24 |
LIDOCAINE HYDROCHLORIDE |
WOCKHARDT BIO AG |
Labeling |
Approval |
11/02/2018 |
SCANDONEST PLAIN ANDA #088387 |
SUPPL-38 |
MEPIVACAINE HYDROCHLORIDE |
DEPROCO |
Labeling |
Approval |
11/02/2018 |
SCANDONEST L ANDA #088388 |
SUPPL-38 |
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE |
DEPROCO |
Labeling |
Approval |
11/02/2018 |
LIGNOSPAN FORTE ANDA #088389 |
SUPPL-43 |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE |
DEPROCO |
Labeling |
Approval |
11/02/2018 |
LIGNOSPAN STANDARD ANDA #088390 |
SUPPL-52 |
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE |
DEPROCO |
Labeling |
Approval |
11/02/2018 |
LIDOCAINE VISCOUS ANDA #088802 |
SUPPL-25 |
LIDOCAINE HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
11/02/2018 |
IRBESARTAN ANDA #090720 |
SUPPL-2 |
IRBESARTAN |
WATSON LABS INC |
Labeling |
Approval |
11/02/2018 |
IRBESARTAN ANDA #091236 |
SUPPL-6 |
IRBESARTAN |
ALEMBIC PHARMS LTD |
Labeling |
Approval |
11/02/2018 |
IRBESARTAN ANDA #200461 |
SUPPL-4 |
IRBESARTAN |
UPSHER SMITH LABS |
Labeling |
Approval |
11/02/2018 |
GADAVIST NDA #201277 |
SUPPL-16 |
GADOBUTROL |
BAYER HLTHCARE |
Labeling |
Approval |
11/02/2018 |
STRIBILD NDA #203100 |
SUPPL-33 |
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
11/02/2018 |
DOTAREM NDA #204781 |
SUPPL-9 |
GADOTERATE MEGLUMINE |
GUERBET |
Labeling |
Approval |
11/02/2018 |
LIDOCAINE ANDA #205318 |
SUPPL-3 |
LIDOCAINE |
ENCUBE |
Labeling |
Approval |
11/02/2018 |
IRBESARTAN ANDA #206194 |
SUPPL-2 |
IRBESARTAN |
HISUN PHARM HANGZHOU |
Labeling |
Approval |
11/02/2018 |
LIDOCAINE ANDA #206297 |
SUPPL-8 |
LIDOCAINE |
AMNEAL PHARMS |
Labeling |
Approval |
11/02/2018 |
LIDOCAINE ANDA #206498 |
SUPPL-2 |
LIDOCAINE |
GLENMARK PHARMS LTD |
Labeling |
Approval |
11/02/2018 |
DICYCLOMINE HYDROCHLORIDE ANDA #207076 |
ORIG-1 |
DICYCLOMINE HYDROCHLORIDE |
SLATE RUN PHARMA |
|
Approval |
11/02/2018 |
SOTALOL HYDROCHLORIDE ANDA #207429 |
ORIG-1 |
SOTALOL HYDROCHLORIDE |
BEXIMCO PHARMS USA |
|
Approval |
11/02/2018 |
GENVOYA NDA #207561 |
SUPPL-20 |
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE |
GILEAD SCIENCES INC |
Labeling |
Approval |
11/02/2018 |
MIDODRINE HYDROCHLORIDE ANDA #207613 |
ORIG-1 |
MIDODRINE HYDROCHLORIDE |
THINQ PHARM-CRO PVT |
|
Approval |
11/02/2018 |
LIDOCAINE ANDA #207810 |
SUPPL-2 |
LIDOCAINE |
ALKEM LABS LTD |
Labeling |
Approval |
11/02/2018 |
ZTLIDO NDA #207962 |
SUPPL-1 |
LIDOCAINE |
SCILEX PHARMS |
Labeling |
Approval |
11/02/2018 |
KOVANAZE NDA #208032 |
SUPPL-4 |
OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE |
ST RENATUS |
Labeling |
Approval |
11/02/2018 |
LIDOCAINE ANDA #208822 |
SUPPL-1 |
LIDOCAINE |
VITRUVIAS THERAP |
Labeling |
Approval |
11/02/2018 |
DSUVIA NDA #209128 |
ORIG-1 |
SUFENTANIL CITRATE |
VERTICAL PHARMS |
Type 3 - New Dosage Form |
Approval |
11/02/2018 |
TERIFLUNOMIDE ANDA #209601 |
ORIG-1 |
TERIFLUNOMIDE |
APOTEX |
|
Approval |
11/02/2018 |
METFORMIN HYDROCHLORIDE ANDA #209674 |
ORIG-1 |
METFORMIN HYDROCHLORIDE |
NOVAST LABS |
|
Approval |
11/02/2018 |
LIDOCAINE ANDA #210256 |
SUPPL-1 |
LIDOCAINE |
TEVA PHARMS USA |
Labeling |
Approval |
11/02/2018 |
LORBRENA NDA #210868 |
ORIG-1 |
LORLATINIB |
PFIZER |
Type 1 - New Molecular Entity |
Approval |
11/02/2018 |
LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #211528 |
ORIG-1 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
APOTEX INC |
|
Tentative Approval |
11/02/2018 |
UDENYCA BLA #761039 |
ORIG-1 |
PEGFILGRASTIM-CBQV |
COHERUS BIOSCIENCES INC |
|
Approval |
11/03/2018 |
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #019952 |
SUPPL-38 |
HEPARIN SODIUM |
B BRAUN |
Labeling |
Approval |
11/03/2018 |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER NDA #019952 |
SUPPL-38 |
HEPARIN SODIUM |
B BRAUN |
Labeling |
Approval |
11/05/2018 |
GEODON NDA #020825 |
SUPPL-59 |
ZIPRASIDONE HYDROCHLORIDE |
VIATRIS |
Labeling |
Approval |
11/05/2018 |
GEODON NDA #020919 |
SUPPL-47 |
ZIPRASIDONE MESYLATE |
VIATRIS |
Labeling |
Approval |
11/05/2018 |
BICILLIN C-R NDA #050138 |
SUPPL-239 |
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE |
KING PHARMS LLC |
Labeling |
Approval |
11/05/2018 |
BICILLIN C-R 900/300 NDA #050138 |
SUPPL-239 |
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE |
KING PHARMS LLC |
Labeling |
Approval |
11/05/2018 |
DYSPORT BLA #125274 |
SUPPL-112 |
abobotulinumtoxinA |
IPSEN BIOPHARM LTD |
|
Approval |
11/05/2018 |
NORETHINDRONE ACETATE ANDA #206490 |
ORIG-1 |
NORETHINDRONE ACETATE |
NOVAST LABS |
|
Approval |
11/05/2018 |
BUPROPION HYDROCHLORIDE ANDA #207224 |
SUPPL-3 |
BUPROPION HYDROCHLORIDE |
ANBISON LAB |
Manufacturing (CMC) |
Approval |
11/05/2018 |
CLINDAMYCIN HYDROCHLORIDE ANDA #207402 |
ORIG-1 |
CLINDAMYCIN HYDROCHLORIDE |
MICRO LABS |
|
Approval |
11/05/2018 |
OMEPRAZOLE ANDA #207740 |
ORIG-1 |
OMEPRAZOLE |
DR REDDYS |
|
Approval |
11/05/2018 |
LEVALBUTEROL HYDROCHLORIDE ANDA #207820 |
ORIG-1 |
LEVALBUTEROL HYDROCHLORIDE |
SUN PHARM |
|
Approval |
11/05/2018 |
LIDOCAINE ANDA #208604 |
SUPPL-1 |
LIDOCAINE |
RISING PHARMA |
Labeling |
Approval |
11/05/2018 |
NITYR NDA #209449 |
SUPPL-6 |
NITISINONE |
CYCLE |
Labeling |
Approval |
11/05/2018 |
FLUOCINOLONE ACETONIDE ANDA #210747 |
ORIG-1 |
FLUOCINOLONE ACETONIDE |
COSETTE |
|
Approval |
11/05/2018 |
ISOSORBIDE MONONITRATE ANDA #210918 |
ORIG-1 |
ISOSORBIDE MONONITRATE |
RICONPHARMA LLC |
|
Approval |
11/06/2018 |
HUMULIN R BLA #018780 |
SUPPL-168 |
INSULIN HUMAN |
LILLY |
|
Approval |
11/06/2018 |
HUMULIN R BLA #018780 |
SUPPL-168 |
INSULIN RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/06/2018 |
HUMULIN R KWIKPEN BLA #018780 |
SUPPL-168 |
INSULIN HUMAN |
LILLY |
|
Approval |
11/06/2018 |
HUMULIN R PEN BLA #018780 |
SUPPL-168 |
INSULIN RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/06/2018 |
HUMULIN N BLA #018781 |
SUPPL-181 |
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/06/2018 |
HUMULIN 70/30 BLA #019717 |
SUPPL-161 |
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/06/2018 |
HUMULIN 70/30 PEN BLA #019717 |
SUPPL-161 |
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN |
LILLY |
|
Approval |
11/06/2018 |
CYSTADANE NDA #020576 |
SUPPL-14 |
BETAINE |
RECORDATI RARE |
Labeling |
Approval |
11/06/2018 |
TRICOR NDA #021203 |
SUPPL-8 |
FENOFIBRATE |
ABBVIE |
Labeling |
Approval |
11/06/2018 |
RIOMET NDA #021591 |
SUPPL-7 |
METFORMIN HYDROCHLORIDE |
RANBAXY |
Labeling |
Approval |
11/06/2018 |
LIPOFEN NDA #021612 |
SUPPL-17 |
FENOFIBRATE |
CIPHER PHARMS INC |
Labeling |
Approval |
11/06/2018 |
TRICOR NDA #021656 |
SUPPL-27 |
FENOFIBRATE |
ABBVIE |
Labeling |
Approval |
11/06/2018 |
INTELENCE NDA #022187 |
SUPPL-23 |
ETRAVIRINE |
JANSSEN R AND D |
Efficacy |
Approval |
11/06/2018 |
PRALUENT BLA #125559 |
SUPPL-18 |
ALIROCUMAB |
REGENERON PHARMACEUTICALS |
|
Approval |
11/06/2018 |
PALONOSETRON HYDROCHLORIDE ANDA #204702 |
ORIG-1 |
PALONOSETRON HYDROCHLORIDE |
EUGIA PHARMA |
|
Approval |
11/06/2018 |
BRYHALI NDA #209355 |
ORIG-1 |
HALOBETASOL PROPIONATE |
BAUSCH |
Type 3 - New Dosage Form |
Approval |
11/06/2018 |
FROVATRIPTAN SUCCINATE ANDA #211292 |
ORIG-1 |
FROVATRIPTAN SUCCINATE |
AMNEAL PHARMS CO |
|
Approval |
11/06/2018 |
EMPLICITI BLA #761035 |
SUPPL-8 |
ELOTUZUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
11/07/2018 |
OMNISCAN NDA #020123 |
SUPPL-47 |
GADODIAMIDE |
GE HEALTHCARE |
Labeling |
Approval |
11/07/2018 |
LUNESTA NDA #021476 |
SUPPL-36 |
ESZOPICLONE |
WAYLIS THERAP |
Labeling |
Approval |
11/07/2018 |
ANTARA (MICRONIZED) NDA #021695 |
SUPPL-19 |
FENOFIBRATE |
LUPIN |
Labeling |
Approval |
11/07/2018 |
GLUMETZA NDA #021748 |
SUPPL-25 |
METFORMIN HYDROCHLORIDE |
SANTARUS INC |
Labeling |
Approval |
11/07/2018 |
OMNISCAN NDA #022066 |
SUPPL-9 |
GADODIAMIDE |
GE HEALTHCARE |
Labeling |
Approval |
11/07/2018 |
TRILIPIX NDA #022224 |
SUPPL-14 |
CHOLINE FENOFIBRATE |
ABBVIE |
Labeling |
Approval |
11/07/2018 |
XARELTO NDA #022406 |
SUPPL-29 |
RIVAROXABAN |
JANSSEN PHARMS |
Labeling |
Approval |
11/07/2018 |
BICILLIN L-A NDA #050141 |
SUPPL-236 |
PENICILLIN G BENZATHINE |
KING PHARMS LLC |
Labeling |
Approval |
11/07/2018 |
CIPROFLOXACIN ANDA #076558 |
SUPPL-41 |
CIPROFLOXACIN |
HIKMA |
Labeling |
Approval |
11/07/2018 |
CIPROFLOXACIN ANDA #076558 |
SUPPL-46 |
CIPROFLOXACIN |
HIKMA |
Labeling |
Approval |
11/07/2018 |
CIPROFLOXACIN HYDROCHLORIDE ANDA #076558 |
SUPPL-41 |
CIPROFLOXACIN HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
11/07/2018 |
CIPROFLOXACIN HYDROCHLORIDE ANDA #076558 |
SUPPL-46 |
CIPROFLOXACIN HYDROCHLORIDE |
HIKMA |
Labeling |
Approval |
11/07/2018 |
NOREPINEPHRINE BITARTRATE ANDA #203662 |
ORIG-1 |
NOREPINEPHRINE BITARTRATE |
HIKMA |
|
Approval |
11/07/2018 |
PRIMATENE MIST NDA #205920 |
ORIG-1 |
EPINEPHRINE |
ARMSTRONG PHARMS |
Type 5 - New Formulation or New Manufacturer |
Approval |
11/07/2018 |
TETRACYCLINE HYDROCHLORIDE ANDA #210662 |
ORIG-1 |
TETRACYCLINE HYDROCHLORIDE |
BRECKENRIDGE |
|
Approval |
11/07/2018 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #211487 |
ORIG-1 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
ASCENT PHARMS INC |
|
Approval |
11/08/2018 |
MARPLAN NDA #011961 |
SUPPL-45 |
ISOCARBOXAZID |
VALIDUS PHARMS INC |
Labeling |
Approval |
11/08/2018 |
FOSRENOL NDA #021468 |
SUPPL-21 |
LANTHANUM CARBONATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
11/08/2018 |
FORTAMET NDA #021574 |
SUPPL-17 |
METFORMIN HYDROCHLORIDE |
ANDRX LABS LLC |
Labeling |
Approval |
11/08/2018 |
SEROMYCIN ANDA #060593 |
SUPPL-35 |
CYCLOSERINE |
CEROVENE INC |
Labeling |
Approval |
11/08/2018 |
SEROMYCIN ANDA #060593 |
SUPPL-36 |
CYCLOSERINE |
CEROVENE INC |
Labeling |
Approval |
11/08/2018 |
SEROMYCIN ANDA #060593 |
SUPPL-37 |
CYCLOSERINE |
CEROVENE INC |
Labeling |
Approval |
11/08/2018 |
SEROMYCIN ANDA #060593 |
SUPPL-38 |
CYCLOSERINE |
CEROVENE INC |
Labeling |
Approval |
11/08/2018 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ANDA #202741 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
11/08/2018 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ANDA #202741 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
11/08/2018 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ANDA #202742 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
11/08/2018 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ANDA #202742 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
11/08/2018 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ANDA #202742 |
SUPPL-4 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
11/08/2018 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ANDA #202770 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
11/08/2018 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ANDA #202770 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
11/08/2018 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ANDA #202771 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
11/08/2018 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ANDA #202771 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
11/08/2018 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ANDA #202772 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
11/08/2018 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ANDA #202772 |
SUPPL-3 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
11/08/2018 |
BIMATOPROST ANDA #203299 |
ORIG-1 |
BIMATOPROST |
HIKMA |
|
Approval |
11/08/2018 |
GANCICLOVIR SODIUM ANDA #204204 |
ORIG-1 |
GANCICLOVIR SODIUM |
SLATE RUN PHARMA |
|
Approval |
11/08/2018 |
FOSRENOL NDA #204734 |
SUPPL-3 |
LANTHANUM CARBONATE |
TAKEDA PHARMS USA |
Labeling |
Approval |
11/08/2018 |
NYSTATIN AND TRIAMCINOLONE ACETONIDE ANDA #207764 |
ORIG-1 |
NYSTATIN; TRIAMCINOLONE ACETONIDE |
ZYDUS LIFESCIENCES |
|
Approval |
11/08/2018 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #208540 |
ORIG-1 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
ALVOGEN |
|
Approval |
11/09/2018 |
NORPRAMIN NDA #014399 |
SUPPL-71 |
DESIPRAMINE HYDROCHLORIDE |
VALIDUS PHARMS |
Labeling |
Approval |
11/09/2018 |
AGGRENOX NDA #020884 |
SUPPL-37 |
ASPIRIN; DIPYRIDAMOLE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
11/09/2018 |
CRESTOR NDA #021366 |
SUPPL-38 |
ROSUVASTATIN CALCIUM |
IPR |
Labeling |
Approval |
11/09/2018 |
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE ANDA #091215 |
ORIG-1 |
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE |
TEVA PHARMS USA |
|
Approval |
11/09/2018 |
KEYTRUDA BLA #125514 |
SUPPL-42 |
PEMBROLIZUMAB |
MERCK SHARP DOHME |
|
Approval |
11/09/2018 |
NORGESTIMATE AND ETHINYL ESTRADIOL ANDA #201896 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORGESTIMATE |
MYLAN |
Labeling |
Approval |
11/09/2018 |
NORGESTIMATE AND ETHINYL ESTRADIOL ANDA #201896 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORGESTIMATE |
MYLAN |
Labeling |
Approval |
11/09/2018 |
NORGESTIMATE AND ETHINYL ESTRADIOL ANDA #201897 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORGESTIMATE |
XIROMED |
Labeling |
Approval |
11/09/2018 |
NORGESTIMATE AND ETHINYL ESTRADIOL ANDA #201897 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORGESTIMATE |
XIROMED |
Labeling |
Approval |
11/09/2018 |
TUDORZA PRESSAIR NDA #202450 |
SUPPL-11 |
ACLIDINIUM BROMIDE |
COVIS |
Labeling |
Approval |
11/09/2018 |
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE ANDA #204209 |
SUPPL-6 |
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE |
LARKEN LABS INC |
Labeling |
Approval |
11/09/2018 |
OFEV NDA #205832 |
SUPPL-10 |
NINTEDANIB ESYLATE |
BOEHRINGER INGELHEIM |
Labeling |
Approval |
11/09/2018 |
ANASTROZOLE ANDA #206037 |
ORIG-1 |
ANASTROZOLE |
BEIJING YILING |
|
Approval |
11/09/2018 |
VALGANCICLOVIR HYDROCHLORIDE ANDA #209672 |
ORIG-1 |
VALGANCICLOVIR HYDROCHLORIDE |
CIPLA |
|
Approval |
11/09/2018 |
DOXYCYCLINE HYCLATE ANDA #209969 |
ORIG-1 |
DOXYCYCLINE HYCLATE |
AVET LIFESCIENCES |
|
Approval |
11/09/2018 |
DIMETHYL FUMARATE ANDA #210291 |
ORIG-1 |
DIMETHYL FUMARATE |
SHILPA MEDICARE LTD |
|
Tentative Approval |
11/09/2018 |
BENZONATATE ANDA #210562 |
ORIG-1 |
BENZONATATE |
CHARTWELL RX |
|
Approval |
11/09/2018 |
YUPELRI NDA #210598 |
ORIG-1 |
REVEFENACIN |
MYLAN IRELAND LTD |
Type 1 - New Molecular Entity |
Approval |
11/09/2018 |
DECITABINE ANDA #210756 |
ORIG-1 |
DECITABINE |
LUPIN LTD |
|
Approval |
11/09/2018 |
BUDESONIDE ANDA #210897 |
ORIG-1 |
BUDESONIDE |
LUPIN |
|
Approval |
11/11/2018 |
PEPCID NDA #019462 |
SUPPL-40 |
FAMOTIDINE |
BAUSCH |
Labeling |
Approval |
11/11/2018 |
VIMPAT NDA #022253 |
SUPPL-42 |
LACOSAMIDE |
UCB INC |
Labeling |
Approval |
11/11/2018 |
VIMPAT NDA #022254 |
SUPPL-33 |
LACOSAMIDE |
UCB INC |
Labeling |
Approval |
11/11/2018 |
VIMPAT NDA #022255 |
SUPPL-24 |
LACOSAMIDE |
UCB INC |
Labeling |
Approval |
11/12/2018 |
MONUROL NDA #050717 |
SUPPL-10 |
FOSFOMYCIN TROMETHAMINE |
ZAMBON SPA |
Labeling |
Approval |
11/12/2018 |
OCREVUS BLA #761053 |
SUPPL-12 |
OCRELIZUMAB |
GENENTECH INC |
|
Approval |
11/13/2018 |
SUDAFED 24 HOUR NDA #020021 |
SUPPL-12 |
PSEUDOEPHEDRINE HYDROCHLORIDE |
J AND J CONSUMER INC |
Labeling |
Approval |
11/13/2018 |
CARISOPRODOL ANDA #040792 |
SUPPL-14 |
CARISOPRODOL |
AUROBINDO PHARMA |
Labeling |
Approval |
11/13/2018 |
CARISOPRODOL ANDA #205126 |
SUPPL-4 |
CARISOPRODOL |
WILSHIRE PHARMS INC |
Labeling |
Approval |
11/13/2018 |
ARSENIC TRIOXIDE ANDA #206228 |
ORIG-1 |
ARSENIC TRIOXIDE |
ZYDUS PHARMS |
|
Approval |
11/13/2018 |
BENDAMUSTINE HYDROCHLORIDE ANDA #210410 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
FRESENIUS KABI USA |
|
Tentative Approval |
11/13/2018 |
BENDAMUSTINE HYDROCHLORIDE ANDA #210601 |
ORIG-1 |
BENDAMUSTINE HYDROCHLORIDE |
APOTEX INC |
|
Tentative Approval |
11/13/2018 |
ARSENIC TRIOXIDE ANDA #210802 |
ORIG-1 |
ARSENIC TRIOXIDE |
AMRING PHARMS |
|
Approval |
11/13/2018 |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE ANDA #210819 |
ORIG-1 |
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
BAYSHORE PHARMS LLC |
|
Approval |
11/14/2018 |
NICORETTE NDA #018612 |
SUPPL-81 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
11/14/2018 |
NICORETTE (MINT) NDA #018612 |
SUPPL-81 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
11/14/2018 |
ADVIL NDA #018989 |
SUPPL-91 |
IBUPROFEN |
HALEON US HOLDINGS |
Labeling |
Approval |
11/14/2018 |
NICORETTE NDA #020066 |
SUPPL-62 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
11/14/2018 |
NICORETTE (MINT) NDA #020066 |
SUPPL-62 |
NICOTINE POLACRILEX |
HALEON US HOLDINGS |
Labeling |
Approval |
11/14/2018 |
SUDAFED 12 HOUR ANDA #073585 |
SUPPL-19 |
PSEUDOEPHEDRINE HYDROCHLORIDE |
MCNEIL CONS |
Labeling |
Approval |
11/14/2018 |
ALFUZOSIN HYDROCHLORIDE ANDA #079014 |
SUPPL-8 |
ALFUZOSIN HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
11/14/2018 |
ALFUZOSIN HYDROCHLORIDE ANDA #079057 |
SUPPL-12 |
ALFUZOSIN HYDROCHLORIDE |
SUN PHARM |
Labeling |
Approval |
11/14/2018 |
LETROZOLE ANDA #205869 |
ORIG-1 |
LETROZOLE |
BEIJING YILING |
|
Approval |
11/14/2018 |
FONDAPARINUX SODIUM ANDA #208615 |
ORIG-1 |
FONDAPARINUX SODIUM |
SCINOPHARM TAIWAN |
|
Approval |
11/15/2018 |
OSMITROL 10% IN WATER NDA #013684 |
SUPPL-98 |
MANNITOL |
BAXTER HLTHCARE |
Labeling |
Approval |
11/15/2018 |
OSMITROL 10% IN WATER NDA #013684 |
SUPPL-104 |
MANNITOL |
BAXTER HLTHCARE |
Efficacy |
Approval |
11/15/2018 |
OSMITROL 10% IN WATER IN PLASTIC CONTAINER NDA #013684 |
SUPPL-98 |
MANNITOL |
BAXTER HLTHCARE |
Labeling |
Approval |
11/15/2018 |
OSMITROL 10% IN WATER IN PLASTIC CONTAINER NDA #013684 |
SUPPL-104 |
MANNITOL |
BAXTER HLTHCARE |
Efficacy |
Approval |
11/15/2018 |
OSMITROL 15% IN WATER NDA #013684 |
SUPPL-98 |
MANNITOL |
BAXTER HLTHCARE |
Labeling |
Approval |
11/15/2018 |
OSMITROL 15% IN WATER NDA #013684 |
SUPPL-104 |
MANNITOL |
BAXTER HLTHCARE |
Efficacy |
Approval |
11/15/2018 |
OSMITROL 15% IN WATER IN PLASTIC CONTAINER NDA #013684 |
SUPPL-98 |
MANNITOL |
BAXTER HLTHCARE |
Labeling |
Approval |
11/15/2018 |
OSMITROL 15% IN WATER IN PLASTIC CONTAINER NDA #013684 |
SUPPL-104 |
MANNITOL |
BAXTER HLTHCARE |
Efficacy |
Approval |
11/15/2018 |
OSMITROL 20% IN WATER NDA #013684 |
SUPPL-98 |
MANNITOL |
BAXTER HLTHCARE |
Labeling |
Approval |
11/15/2018 |
OSMITROL 20% IN WATER NDA #013684 |
SUPPL-104 |
MANNITOL |
BAXTER HLTHCARE |
Efficacy |
Approval |
11/15/2018 |
OSMITROL 20% IN WATER IN PLASTIC CONTAINER NDA #013684 |
SUPPL-98 |
MANNITOL |
BAXTER HLTHCARE |
Labeling |
Approval |
11/15/2018 |
OSMITROL 20% IN WATER IN PLASTIC CONTAINER NDA #013684 |
SUPPL-104 |
MANNITOL |
BAXTER HLTHCARE |
Efficacy |
Approval |
11/15/2018 |
OSMITROL 5% IN WATER NDA #013684 |
SUPPL-98 |
MANNITOL |
BAXTER HLTHCARE |
Labeling |
Approval |
11/15/2018 |
OSMITROL 5% IN WATER NDA #013684 |
SUPPL-104 |
MANNITOL |
BAXTER HLTHCARE |
Efficacy |
Approval |
11/15/2018 |
OSMITROL 5% IN WATER IN PLASTIC CONTAINER NDA #013684 |
SUPPL-98 |
MANNITOL |
BAXTER HLTHCARE |
Labeling |
Approval |
11/15/2018 |
OSMITROL 5% IN WATER IN PLASTIC CONTAINER NDA #013684 |
SUPPL-104 |
MANNITOL |
BAXTER HLTHCARE |
Efficacy |
Approval |
11/15/2018 |
NORVIR NDA #020659 |
SUPPL-69 |
RITONAVIR |
ABBVIE |
Labeling |
Approval |
11/15/2018 |
NORVIR NDA #020945 |
SUPPL-45 |
RITONAVIR |
ABBVIE |
Labeling |
Approval |
11/15/2018 |
EPIVIR-HBV NDA #021003 |
SUPPL-20 |
LAMIVUDINE |
GLAXOSMITHKLINE |
Efficacy |
Approval |
11/15/2018 |
EPIVIR-HBV NDA #021004 |
SUPPL-20 |
LAMIVUDINE |
GLAXOSMITHKLINE |
Efficacy |
Approval |
11/15/2018 |
KALETRA NDA #021226 |
SUPPL-46 |
LOPINAVIR; RITONAVIR |
ABBVIE |
Labeling |
Approval |
11/15/2018 |
KALETRA NDA #021251 |
SUPPL-56 |
LOPINAVIR; RITONAVIR |
ABBVIE |
Labeling |
Approval |
11/15/2018 |
KALETRA NDA #021906 |
SUPPL-51 |
LOPINAVIR; RITONAVIR |
ABBVIE |
Labeling |
Approval |
11/15/2018 |
SPRYCEL NDA #021986 |
SUPPL-23 |
DASATINIB |
BRISTOL MYERS SQUIBB |
Labeling |
Approval |
11/15/2018 |
NORVIR NDA #022417 |
SUPPL-21 |
RITONAVIR |
ABBVIE |
Labeling |
Approval |
11/15/2018 |
ABACAVIR SULFATE AND LAMIVUDINE ANDA #090159 |
ORIG-1 |
ABACAVIR SULFATE; LAMIVUDINE |
AUROBINDO PHARMA LTD |
|
Approval |
11/15/2018 |
OPDIVO BLA #125554 |
SUPPL-69 |
NIVOLUMAB |
BRISTOL MYERS SQUIBB |
|
Approval |
11/15/2018 |
PROPOFOL ANDA #205067 |
ORIG-1 |
PROPOFOL |
DR REDDYS |
|
Approval |
11/15/2018 |
KETOROLAC TROMETHAMINE ANDA #205191 |
ORIG-1 |
KETOROLAC TROMETHAMINE |
EUGIA PHARMA |
|
Approval |
11/15/2018 |
ABACAVIR SULFATE AND LAMIVUDINE ANDA #208990 |
ORIG-1 |
ABACAVIR SULFATE; LAMIVUDINE |
ZYDUS PHARMS |
|
Approval |
11/15/2018 |
RADICAVA NDA #209176 |
SUPPL-7 |
EDARAVONE |
MITSUBISHI TANABE |
Manufacturing (CMC) |
Approval |
11/15/2018 |
ARSENIC TRIOXIDE ANDA #209315 |
ORIG-1 |
ARSENIC TRIOXIDE |
INGENUS PHARMS LLC |
|
Approval |
11/15/2018 |
NORVIR NDA #209512 |
SUPPL-4 |
RITONAVIR |
ABBVIE |
Labeling |
Approval |
11/15/2018 |
TERIFLUNOMIDE ANDA #209663 |
ORIG-1 |
TERIFLUNOMIDE |
GLENMARK SPECLT |
|
Approval |
11/15/2018 |
ARSENIC TRIOXIDE ANDA #209780 |
ORIG-1 |
ARSENIC TRIOXIDE |
NEXUS |
|
Approval |
11/16/2018 |
HEPARIN SODIUM NDA #017029 |
SUPPL-141 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
11/16/2018 |
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% NDA #017029 |
SUPPL-141 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
11/16/2018 |
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% NDA #017029 |
SUPPL-141 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
11/16/2018 |
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% NDA #017029 |
SUPPL-141 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
11/16/2018 |
HEPARIN SODIUM IN PLASTIC CONTAINER NDA #017029 |
SUPPL-141 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
11/16/2018 |
HEPARIN SODIUM PRESERVATIVE FREE NDA #017029 |
SUPPL-141 |
HEPARIN SODIUM |
FRESENIUS KABI USA |
Labeling |
Approval |
11/16/2018 |
TOTECT NDA #022025 |
SUPPL-18 |
DEXRAZOXANE HYDROCHLORIDE |
CLINIGEN |
Labeling |
Approval |
11/16/2018 |
PROMACTA NDA #022291 |
SUPPL-21 |
ELTROMBOPAG OLAMINE |
NOVARTIS |
Efficacy |
Approval |
11/16/2018 |
LINCOCIN NDA #050317 |
SUPPL-183 |
LINCOMYCIN HYDROCHLORIDE |
PFIZER |
Labeling |
Approval |
11/16/2018 |
MINOCIN NDA #050445 |
SUPPL-30 |
MINOCYCLINE HYDROCHLORIDE |
BAUSCH |
Labeling |
Approval |
11/16/2018 |
ELAPRASE BLA #125151 |
SUPPL-197 |
IDURSULFASE |
SHIRE |
|
Approval |
11/16/2018 |
ADCETRIS BLA #125388 |
SUPPL-99 |
BRENTUXIMAB VEDOTIN |
SEATTLE GENETICS |
|
Approval |
11/16/2018 |
MITIGARE NDA #204820 |
SUPPL-4 |
COLCHICINE |
HIKMA INTL PHARMS |
Manufacturing (CMC) |
Approval |
11/16/2018 |
NAPROXEN SODIUM ANDA #207612 |
ORIG-1 |
NAPROXEN SODIUM |
NOVELGENIX THERAPS |
|
Approval |
11/16/2018 |
VARDENAFIL HYDROCHLORIDE ANDA #208324 |
ORIG-1 |
VARDENAFIL HYDROCHLORIDE |
ALEMBIC |
|
Approval |
11/16/2018 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ANDA #209924 |
ORIG-1 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
ELITE LABS INC |
|
Approval |
11/16/2018 |
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE ANDA #210719 |
ORIG-1 |
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
PPI-DAC |
|
Approval |
11/16/2018 |
AEMCOLO NDA #210910 |
ORIG-1 |
RIFAMYCIN SODIUM |
REDHILL |
Type 1 - New Molecular Entity |
Approval |
11/16/2018 |
TEMIXYS NDA #211284 |
ORIG-1 |
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE |
CHARTWELL RX |
Type 5 - New Formulation or New Manufacturer |
Approval |
11/16/2018 |
SUCCINYLCHOLINE CHLORIDE ANDA #211432 |
ORIG-1 |
SUCCINYLCHOLINE CHLORIDE |
AMNEAL |
|
Approval |
11/16/2018 |
TAKHZYRO BLA #761090 |
SUPPL-1 |
LANADELUMAB-FLYO |
DYAX CORP. |
|
Approval |
11/19/2018 |
ACTEMRA BLA #125276 |
SUPPL-118 |
TOCILIZUMAB |
GENENTECH |
|
Approval |
11/19/2018 |
ACTEMRA BLA #125472 |
SUPPL-29 |
TOCILIZUMAB |
GENENTECH |
|
Approval |
11/19/2018 |
RAMIPRIL ANDA #202392 |
SUPPL-2 |
RAMIPRIL |
ACCORD HLTHCARE |
Labeling |
Approval |
11/19/2018 |
RAMIPRIL ANDA #202392 |
SUPPL-3 |
RAMIPRIL |
ACCORD HLTHCARE |
Labeling |
Approval |
11/19/2018 |
ZOLEDRONIC ACID ANDA #204344 |
ORIG-1 |
ZOLEDRONIC ACID |
DR REDDYS |
|
Approval |
11/19/2018 |
AZELAIC ACID ANDA #204637 |
ORIG-1 |
AZELAIC ACID |
GLENMARK SPECLT |
|
Approval |
11/19/2018 |
NATEGLINIDE ANDA #205248 |
SUPPL-1 |
NATEGLINIDE |
ZYDUS PHARMS |
Labeling |
Approval |
11/19/2018 |
NATEGLINIDE ANDA #205248 |
SUPPL-2 |
NATEGLINIDE |
ZYDUS PHARMS |
Labeling |
Approval |
11/19/2018 |
OLANZAPINE ANDA #206238 |
ORIG-1 |
OLANZAPINE |
SUNSHINE |
|
Approval |
11/19/2018 |
QVAR REDIHALER NDA #207921 |
SUPPL-3 |
BECLOMETHASONE DIPROPIONATE |
NORTON WATERFORD |
Manufacturing (CMC) |
Tentative Approval |
11/19/2018 |
AZELAIC ACID ANDA #208011 |
ORIG-1 |
AZELAIC ACID |
ACTAVIS LABS UT INC |
|
Approval |
11/19/2018 |
RABEPRAZOLE SODIUM ANDA #208644 |
SUPPL-2 |
RABEPRAZOLE SODIUM |
ALKEM LABS LTD |
Labeling |
Approval |
11/19/2018 |
AZELAIC ACID ANDA #208724 |
ORIG-1 |
AZELAIC ACID |
ENCUBE |
|
Approval |
11/19/2018 |
DOCOSANOL ANDA #208754 |
ORIG-1 |
DOCOSANOL |
P AND L |
|
Approval |
11/19/2018 |
HEPARIN SODIUM ANDA #208827 |
ORIG-1 |
HEPARIN SODIUM |
B BRAUN MEDICAL INC |
|
Approval |
11/20/2018 |
GEMZAR NDA #020509 |
SUPPL-81 |
GEMCITABINE HYDROCHLORIDE |
LILLY |
Labeling |
Approval |
11/20/2018 |
BIMATOPROST ANDA #090449 |
SUPPL-3 |
BIMATOPROST |
APOTEX |
Manufacturing (CMC) |
Approval |
11/20/2018 |
CALCIUM ACETATE ANDA #091312 |
SUPPL-1 |
CALCIUM ACETATE |
CHARTWELL RX |
Manufacturing (CMC) |
Approval |
11/20/2018 |
DYCLOPRO ANDA #200480 |
ORIG-1 |
DYCLONINE HYDROCHLORIDE |
SEPTODONT |
|
Approval |
11/20/2018 |
MESALAMINE ANDA #203574 |
ORIG-1 |
MESALAMINE |
MYLAN |
|
Approval |
11/20/2018 |
TREPROSTINIL ANDA #203649 |
SUPPL-2 |
TREPROSTINIL |
SANDOZ |
Labeling |
Approval |
11/20/2018 |
TREPROSTINIL ANDA #203649 |
SUPPL-4 |
TREPROSTINIL |
SANDOZ |
Labeling |
Approval |
11/20/2018 |
TREPROSTINIL ANDA #203649 |
SUPPL-5 |
TREPROSTINIL |
SANDOZ |
Labeling |
Approval |
11/20/2018 |
BUPRENORPHINE ANDA #204937 |
ORIG-1 |
BUPRENORPHINE |
WATSON LABS TEVA |
|
Approval |
11/20/2018 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ANDA #205049 |
SUPPL-1 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
11/20/2018 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ANDA #205049 |
SUPPL-2 |
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE |
XIROMED |
Labeling |
Approval |
11/20/2018 |
ATORVASTATIN CALCIUM ANDA #206536 |
ORIG-1 |
ATORVASTATIN CALCIUM |
ZYDUS PHARMS |
|
Approval |
11/20/2018 |
IMATINIB MESYLATE ANDA #207586 |
SUPPL-1 |
IMATINIB MESYLATE |
HIKMA |
Manufacturing (CMC) |
Approval |
11/20/2018 |
IMATINIB MESYLATE ANDA #207586 |
SUPPL-2 |
IMATINIB MESYLATE |
HIKMA |
Labeling |
Approval |
11/20/2018 |
READYPREP CHG NDA #207964 |
ORIG-1 |
CHLORHEXIDINE GLUCONATE |
MEDLINE INDUSTRIES |
Type 5 - New Formulation or New Manufacturer |
Approval |
11/20/2018 |
VIGABATRIN ANDA #211481 |
ORIG-1 |
VIGABATRIN |
DR REDDYS |
|
Approval |
11/20/2018 |
LEVOCETIRIZINE DIHYDROCHLORIDE ANDA #211551 |
ORIG-1 |
LEVOCETIRIZINE DIHYDROCHLORIDE |
MICRO LABS |
|
Approval |
11/20/2018 |
GAMIFANT BLA #761107 |
ORIG-1 |
EMAPALUMAB-LZSG |
NOVIMMUNE S.A. |
|
Approval |
11/21/2018 |
DENAVIR NDA #020629 |
SUPPL-19 |
PENCICLOVIR |
MYLAN |
Labeling |
Approval |
11/21/2018 |
ZEMPLAR NDA #020819 |
SUPPL-30 |
PARICALCITOL |
ABBVIE |
Labeling |
Approval |
11/21/2018 |
HECTOROL NDA #020862 |
SUPPL-31 |
DOXERCALCIFEROL |
SANOFI |
Labeling |
Approval |
11/21/2018 |
HECTOROL NDA #021027 |
SUPPL-34 |
DOXERCALCIFEROL |
SANOFI |
Labeling |
Approval |
11/21/2018 |
CHILDREN'S CLARITIN NDA #021891 |
SUPPL-29 |
LORATADINE |
BAYER HEALTHCARE LLC |
Manufacturing (CMC) |
Approval |
11/21/2018 |
CLARITIN NDA #021891 |
SUPPL-29 |
LORATADINE |
BAYER HEALTHCARE LLC |
Manufacturing (CMC) |
Approval |
11/21/2018 |
TRESIBA BLA #203314 |
SUPPL-10 |
INSULIN DEGLUDEC |
NOVO |
|
Approval |
11/21/2018 |
VENLAFAXINE HYDROCHLORIDE ANDA #206250 |
ORIG-1 |
VENLAFAXINE HYDROCHLORIDE |
CADILA PHARMS LTD |
|
Approval |
11/21/2018 |
VENCLEXTA NDA #208573 |
SUPPL-9 |
VENETOCLAX |
ABBVIE |
Efficacy |
Approval |
11/21/2018 |
CLOMIPRAMINE HYDROCHLORIDE ANDA #209294 |
ORIG-1 |
CLOMIPRAMINE HYDROCHLORIDE |
LUPIN LTD |
|
Approval |
11/21/2018 |
DICLOFENAC SODIUM ANDA #209484 |
ORIG-1 |
DICLOFENAC SODIUM |
HIKMA |
|
Approval |
11/21/2018 |
ATOVAQUONE ANDA #209685 |
ORIG-1 |
ATOVAQUONE |
GLENMARK SPECLT |
|
Approval |
11/21/2018 |
CALCITRIOL ANDA #209798 |
ORIG-1 |
CALCITRIOL |
RISING PHARMA |
|
Approval |
11/21/2018 |
POTASSIUM CHLORIDE ANDA #210241 |
ORIG-1 |
POTASSIUM CHLORIDE |
NOVEL LABS INC |
|
Approval |
11/21/2018 |
DAURISMO NDA #210656 |
ORIG-1 |
GLASDEGIB MALEATE |
PFIZER |
Type 1 - New Molecular Entity |
Approval |
11/21/2018 |
METHYLPHENIDATE HYDROCHLORIDE ANDA #210992 |
ORIG-1 |
METHYLPHENIDATE HYDROCHLORIDE |
GRANULES |
|
Approval |
11/21/2018 |
FLUOXETINE HYDROCHLORIDE ANDA #211477 |
ORIG-1 |
FLUOXETINE HYDROCHLORIDE |
TARO |
|
Approval |
11/21/2018 |
SPY AGENT GREEN KIT NDA #211580 |
ORIG-1 |
INDOCYANINE GREEN |
NOVADAQ TECH |
Type 5 - New Formulation or New Manufacturer |
Approval |
11/23/2018 |
AQUAMEPHYTON NDA #012223 |
SUPPL-42 |
PHYTONADIONE |
PAI HOLDINGS PHARM |
Labeling |
Approval |
11/23/2018 |
VENLAFAXINE HYDROCHLORIDE ANDA #201272 |
ORIG-1 |
VENLAFAXINE HYDROCHLORIDE |
INTELLIPHARMACEUTICS |
|
Approval |
11/23/2018 |
PRAVASTATIN SODIUM ANDA #206061 |
ORIG-1 |
PRAVASTATIN SODIUM |
HISUN PHARM HANGZHOU |
|
Approval |
11/23/2018 |
ROFLUMILAST ANDA #208213 |
ORIG-1 |
ROFLUMILAST |
HETERO LABS LTD III |
|
Approval |
11/23/2018 |
EPTIFIBATIDE ANDA #208554 |
ORIG-1 |
EPTIFIBATIDE |
BAXTER HLTHCARE CORP |
|
Approval |
11/23/2018 |
LACTULOSE ANDA #209517 |
ORIG-1 |
LACTULOSE |
CHARTWELL RX |
|
Approval |
11/23/2018 |
TRIAMCINOLONE ACETONIDE ANDA #209828 |
ORIG-1 |
TRIAMCINOLONE ACETONIDE |
MACLEODS PHARMS LTD |
|
Approval |
11/23/2018 |
POTASSIUM CHLORIDE ANDA #210200 |
ORIG-1 |
POTASSIUM CHLORIDE |
EPIC PHARMA LLC |
|
Approval |
11/23/2018 |
IBUPROFEN ANDA #210602 |
ORIG-1 |
IBUPROFEN |
APTAPHARMA INC |
|
Approval |
11/23/2018 |
RANITIDINE HYDROCHLORIDE ANDA #210681 |
ORIG-1 |
RANITIDINE HYDROCHLORIDE |
NOVITIUM PHARMA |
|
Approval |
11/23/2018 |
LEUCOVORIN CALCIUM ANDA #210917 |
ORIG-1 |
LEUCOVORIN CALCIUM |
NOVAST LABS |
|
Approval |
11/23/2018 |
LIDOCAINE ANDA #211469 |
ORIG-1 |
LIDOCAINE |
ALEMBIC |
|
Approval |
11/23/2018 |
TEMAZEPAM ANDA #211542 |
ORIG-1 |
TEMAZEPAM |
ALEMBIC |
|
Approval |
11/23/2018 |
BACLOFEN ANDA #211659 |
ORIG-1 |
BACLOFEN |
ZYDUS LIFESCIENCES |
|
Approval |
11/25/2018 |
BIAXIN NDA #050662 |
SUPPL-59 |
CLARITHROMYCIN |
ABBVIE |
Labeling |
Approval |
11/25/2018 |
BIAXIN NDA #050698 |
SUPPL-39 |
CLARITHROMYCIN |
ABBVIE |
Labeling |
Approval |
11/25/2018 |
BIAXIN XL NDA #050775 |
SUPPL-27 |
CLARITHROMYCIN |
ABBVIE |
Labeling |
Approval |
11/26/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #076798 |
SUPPL-3 |
PIOGLITAZONE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
11/26/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #076798 |
SUPPL-4 |
PIOGLITAZONE HYDROCHLORIDE |
CHARTWELL RX |
Labeling |
Approval |
11/26/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #077210 |
SUPPL-2 |
PIOGLITAZONE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
11/26/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #077210 |
SUPPL-3 |
PIOGLITAZONE HYDROCHLORIDE |
TEVA PHARMS USA |
Labeling |
Approval |
11/26/2018 |
CYRAMZA BLA #125477 |
SUPPL-31 |
RAMUCIRUMAB |
ELI LILLY AND CO |
|
Approval |
11/26/2018 |
GLIMEPIRIDE ANDA #202112 |
SUPPL-5 |
GLIMEPIRIDE |
INDOCO REMEDIES |
Labeling |
Approval |
11/26/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #202456 |
SUPPL-1 |
PIOGLITAZONE HYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
11/26/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #202456 |
SUPPL-2 |
PIOGLITAZONE HYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
11/26/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #202456 |
SUPPL-3 |
PIOGLITAZONE HYDROCHLORIDE |
ZYDUS PHARMS USA INC |
Labeling |
Approval |
11/26/2018 |
CINACALCET HYDROCHLORIDE ANDA #208971 |
ORIG-1 |
CINACALCET HYDROCHLORIDE |
ZYDUS PHARMS USA INC |
|
Tentative Approval |
11/26/2018 |
SODIUM NITROPRUSSIDE ANDA #210467 |
ORIG-1 |
SODIUM NITROPRUSSIDE |
SUN PHARM |
|
Approval |
11/26/2018 |
VITRAKVI NDA #210861 |
ORIG-1 |
LAROTRECTINIB SULFATE |
BAYER HLTHCARE |
Type 1 - New Molecular Entity |
Approval |
11/26/2018 |
VITRAKVI NDA #211710 |
ORIG-1 |
LAROTRECTINIB SULFATE |
BAYER HEALTHCARE |
Type 3 - New Dosage Form |
Approval |
11/27/2018 |
ISTODAX NDA #022393 |
SUPPL-15 |
ROMIDEPSIN |
BRISTOL-MYERS |
Labeling |
Approval |
11/27/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #091298 |
SUPPL-7 |
PIOGLITAZONE HYDROCHLORIDE |
TORRENT PHARMS LTD |
Labeling |
Approval |
11/27/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #091298 |
SUPPL-9 |
PIOGLITAZONE HYDROCHLORIDE |
TORRENT PHARMS LTD |
Labeling |
Approval |
11/27/2018 |
LANSOPRAZOLE ANDA #200816 |
ORIG-1 |
LANSOPRAZOLE |
ZYDUS PHARMS |
|
Approval |
11/27/2018 |
OXYCODONE AND ACETAMINOPHEN ANDA #202142 |
ORIG-1 |
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
MIKART |
|
Approval |
11/27/2018 |
TENOFOVIR DISOPROXIL FUMARATE ANDA #206569 |
ORIG-1 |
TENOFOVIR DISOPROXIL FUMARATE |
NORVIUM BIOSCIENCE |
|
Approval |
11/27/2018 |
AMINOCAPROIC ACID ANDA #209060 |
ORIG-1 |
AMINOCAPROIC ACID |
SUNNY |
|
Approval |
11/27/2018 |
ARGATROBAN IN SODIUM CHLORIDE NDA #209552 |
ORIG-1 |
ARGATROBAN |
EUGIA PHARMA SPECLTS |
Type 5 - New Formulation or New Manufacturer |
Approval |
11/28/2018 |
REGRANEX BLA #103691 |
SUPPL-5134 |
BECAPLERMIN |
SMITH AND NEPHEW |
|
Approval |
11/28/2018 |
CAMPATH BLA #103948 |
SUPPL-5160 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
11/28/2018 |
CAMPATH BLA #103948 |
SUPPL-5165 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
11/28/2018 |
LEMTRADA BLA #103948 |
SUPPL-5160 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
11/28/2018 |
LEMTRADA BLA #103948 |
SUPPL-5165 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
11/28/2018 |
LANSOPRAZOLE ANDA #202396 |
ORIG-1 |
LANSOPRAZOLE |
MYLAN |
|
Approval |
11/28/2018 |
VRAYLAR NDA #204370 |
SUPPL-5 |
CARIPRAZINE HYDROCHLORIDE |
ABBVIE |
Labeling |
Approval |
11/28/2018 |
FIRDAPSE NDA #208078 |
ORIG-1 |
AMIFAMPRIDINE PHOSPHATE |
CATALYST PHARMS |
Type 1 - New Molecular Entity |
Approval |
11/28/2018 |
GLYCOPYRROLATE ANDA #210244 |
ORIG-1 |
GLYCOPYRROLATE |
EUGIA PHARMA |
|
Approval |
11/28/2018 |
XOSPATA NDA #211349 |
ORIG-1 |
GILTERITINIB FUMARATE |
ASTELLAS |
Type 1 - New Molecular Entity |
Approval |
11/28/2018 |
TRUXIMA BLA #761088 |
ORIG-1 |
RITUXIMAB-ABBS |
CELLTRION INC |
|
Approval |
11/29/2018 |
CHILDREN'S MOTRIN NDA #020516 |
SUPPL-36 |
IBUPROFEN |
J AND J CONSUMER INC |
Labeling |
Approval |
11/29/2018 |
SEROQUEL NDA #020639 |
SUPPL-60 |
QUETIAPINE FUMARATE |
ASTRAZENECA |
Labeling |
Approval |
11/29/2018 |
SEROQUEL NDA #020639 |
SUPPL-63 |
QUETIAPINE FUMARATE |
ASTRAZENECA |
Labeling |
Approval |
11/29/2018 |
LANTUS BLA #021081 |
SUPPL-71 |
INSULIN GLARGINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
11/29/2018 |
LANTUS SOLOSTAR BLA #021081 |
SUPPL-71 |
INSULIN GLARGINE RECOMBINANT |
SANOFI AVENTIS US |
|
Approval |
11/29/2018 |
NEUPRO NDA #021829 |
SUPPL-15 |
ROTIGOTINE |
UCB INC |
Labeling |
Approval |
11/29/2018 |
ARRANON NDA #021877 |
SUPPL-9 |
NELARABINE |
SANDOZ |
Labeling |
Approval |
11/29/2018 |
OSMOPREP NDA #021892 |
SUPPL-14 |
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
SALIX PHARMS |
Labeling |
Approval |
11/29/2018 |
NAPROXEN SODIUM NDA #021920 |
SUPPL-22 |
NAPROXEN SODIUM |
BIONPHARMA |
Labeling |
Approval |
11/29/2018 |
SEROQUEL XR NDA #022047 |
SUPPL-33 |
QUETIAPINE FUMARATE |
ASTRAZENECA |
Labeling |
Approval |
11/29/2018 |
SEROQUEL XR NDA #022047 |
SUPPL-37 |
QUETIAPINE FUMARATE |
ASTRAZENECA |
Labeling |
Approval |
11/29/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #076801 |
SUPPL-4 |
PIOGLITAZONE HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
11/29/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #076801 |
SUPPL-6 |
PIOGLITAZONE HYDROCHLORIDE |
NORVIUM BIOSCIENCE |
Labeling |
Approval |
11/29/2018 |
HERCEPTIN BLA #103792 |
SUPPL-5345 |
TRASTUZUMAB |
GENENTECH |
|
Approval |
11/29/2018 |
CAMPATH BLA #103948 |
SUPPL-5167 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
11/29/2018 |
LEMTRADA BLA #103948 |
SUPPL-5167 |
ALEMTUZUMAB |
GENZYME |
|
Approval |
11/29/2018 |
ASTAGRAF XL NDA #204096 |
SUPPL-5 |
TACROLIMUS |
ASTELLAS |
Efficacy |
Approval |
11/29/2018 |
SEVELAMER CARBONATE ANDA #204451 |
ORIG-1 |
SEVELAMER CARBONATE |
RISING PHARMA |
|
Approval |
11/29/2018 |
OXCARBAZEPINE ANDA #206576 |
ORIG-1 |
OXCARBAZEPINE |
TWI PHARMS INC |
|
Tentative Approval |
11/29/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #206738 |
SUPPL-1 |
PIOGLITAZONE HYDROCHLORIDE |
PURACAP PHARM LLC |
Labeling |
Approval |
11/29/2018 |
DEXMEDETOMIDINE HYDROCHLORIDE ANDA #208129 |
ORIG-1 |
DEXMEDETOMIDINE HYDROCHLORIDE |
FRESENIUS KABI USA |
|
Approval |
11/29/2018 |
COLCHICINE ANDA #208678 |
ORIG-1 |
COLCHICINE |
ENDO OPERATIONS |
|
Approval |
11/29/2018 |
FLUOCINONIDE ANDA #209699 |
ORIG-1 |
FLUOCINONIDE |
ENCUBE ETHICALS |
|
Approval |
11/30/2018 |
HIBICLENS NDA #017768 |
SUPPL-49 |
CHLORHEXIDINE GLUCONATE |
MOLNLYCKE HLTH |
Labeling |
Approval |
11/30/2018 |
NIZORAL ANTI-DANDRUFF NDA #020310 |
SUPPL-22 |
KETOCONAZOLE |
KRAMER |
Manufacturing (CMC) |
Approval |
11/30/2018 |
LETAIRIS NDA #022081 |
SUPPL-40 |
AMBRISENTAN |
GILEAD |
Labeling |
Approval |
11/30/2018 |
NATEGLINIDE ANDA #077461 |
SUPPL-3 |
NATEGLINIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/30/2018 |
NATEGLINIDE ANDA #077461 |
SUPPL-4 |
NATEGLINIDE |
DR REDDYS LABS LTD |
Labeling |
Approval |
11/30/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #200268 |
SUPPL-6 |
PIOGLITAZONE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/30/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #200268 |
SUPPL-7 |
PIOGLITAZONE HYDROCHLORIDE |
AUROBINDO PHARMA LTD |
Labeling |
Approval |
11/30/2018 |
RABEPRAZOLE SODIUM ANDA #202376 |
SUPPL-8 |
RABEPRAZOLE SODIUM |
TORRENT |
Labeling |
Approval |
11/30/2018 |
RABEPRAZOLE SODIUM ANDA #202376 |
SUPPL-10 |
RABEPRAZOLE SODIUM |
TORRENT |
Labeling |
Approval |
11/30/2018 |
RABEPRAZOLE SODIUM ANDA #202376 |
SUPPL-13 |
RABEPRAZOLE SODIUM |
TORRENT |
Labeling |
Approval |
11/30/2018 |
RABEPRAZOLE SODIUM ANDA #202376 |
SUPPL-14 |
RABEPRAZOLE SODIUM |
TORRENT |
Labeling |
Approval |
11/30/2018 |
XALKORI NDA #202570 |
SUPPL-26 |
CRIZOTINIB |
PF PRISM CV |
Efficacy |
Approval |
11/30/2018 |
BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE ANDA #202584 |
ORIG-1 |
BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE |
NOSTRUM LABS INC |
|
Approval |
11/30/2018 |
GLYCOPYRROLATE ANDA #203657 |
ORIG-1 |
GLYCOPYRROLATE |
ALEMBIC |
|
Approval |
11/30/2018 |
PIOGLITAZONE HYDROCHLORIDE ANDA #204133 |
SUPPL-2 |
PIOGLITAZONE HYDROCHLORIDE |
ANNORA PHARMA |
Labeling |
Approval |
11/30/2018 |
FYREMADEL ANDA #204246 |
ORIG-1 |
GANIRELIX ACETATE |
SUN PHARM |
|
Approval |
11/30/2018 |
DIPHENHYDRAMINE HYDROCHLORIDE ANDA #205723 |
SUPPL-1 |
DIPHENHYDRAMINE HYDROCHLORIDE |
MICRO LABS |
Manufacturing (CMC) |
Approval |
11/30/2018 |
LAMOTRIGINE ANDA #207497 |
ORIG-1 |
LAMOTRIGINE |
AMNEAL PHARMS |
|
Approval |
11/30/2018 |
ARISTADA NDA #207533 |
SUPPL-13 |
ARIPIPRAZOLE LAUROXIL |
ALKERMES INC |
Labeling |
Approval |
11/30/2018 |
SERNIVO NDA #208079 |
SUPPL-1 |
BETAMETHASONE DIPROPIONATE |
PRIMUS PHARMS |
Labeling |
Approval |
11/30/2018 |
DEXTENZA NDA #208742 |
ORIG-1 |
DEXAMETHASONE |
OCULAR THERAPEUTIX |
Type 3 - New Dosage Form |
Approval |
11/30/2018 |
TERIFLUNOMIDE ANDA #209668 |
ORIG-1 |
TERIFLUNOMIDE |
ZYDUS PHARMS |
|
Approval |
11/30/2018 |
ETODOLAC ANDA #209888 |
ORIG-1 |
ETODOLAC |
EDENBRIDGE PHARMS |
|
Approval |
11/30/2018 |
METHYLPHENIDATE HYDROCHLORIDE ANDA #210818 |
ORIG-1 |
METHYLPHENIDATE HYDROCHLORIDE |
ALVOGEN |
|
Approval |
11/30/2018 |
VORICONAZOLE ANDA #211661 |
ORIG-1 |
VORICONAZOLE |
SLATE RUN PHARMA |
|
Approval |