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Amneal
FDA Approves MORPHINE SULFATE — Amneal Pharmaceuticals of New York LLC

# FDA Approves Amneal Pharmaceuticals' Generic Morphine Sulfate Oral Formulation Amneal Pharmaceuticals of New York LLC received FDA approval for its...

Rhodes
FDA Approves HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Rhodes Pharmaceuticals LLC

Rhodes Pharmaceuticals received FDA approval for the ANDA for its generic version of Hydrocodone Bitartrate and Acetaminophen, a move that is expected...

AbbVie
FDA Approves VENCLEXTA — AbbVie Inc.

# FDA Approves AbbVie's VENCLEXTA (venetoclax) for Chronic Lymphocytic Leukemia AbbVie Inc. received FDA approval for VENCLEXTA (venetoclax), an oral...

Amneal
FDA Approves DESIPRAMINE HYDROCHLORIDE — Amneal Pharmaceuticals NY LLC

# FDA Approves Desipramine Hydrochloride Generic Amneal Pharmaceuticals NY LLC has received FDA approval for its generic desipramine hydrochloride or...

Pfizer
FDA Approves XELJANZ XR — Pfizer Laboratories Div Pfizer Inc

On February 23, 2016, the FDA granted approval to Pfizer's oral TOFACITINIB CITRATE for XELJANZ XR, marking a strategic expansion of the rheumatoid ar...

ScieGen
FDA Approves GABAPENTIN — ScieGen Pharmaceuticals, Inc.

# FDA Approves ScieGen Pharmaceuticals' Generic Gabapentin ScieGen Pharmaceuticals, Inc. received FDA approval for its generic gabapentin oral formul...

Sagent
FDA Approves FLUOROURACIL — Sagent Pharmaceuticals

# FDA Approves Sagent Pharmaceuticals' Generic Fluorouracil Injection Sagent Pharmaceuticals has received FDA approval for its generic fluorouracil i...

ACCORD
FDA Approves Unknown Drug — ACCORD HLTHCARE

# FDA Approves ANDA Submission for Accord Healthcare Accord Healthcare has received FDA approval for its abbreviated new drug application (ANDA206058...

Creekwood
FDA Approves GABAPENTIN — Creekwood Pharmaceuticals LLC

# FDA Approves Generic Gabapentin from Creekwood Pharmaceuticals Creekwood Pharmaceuticals LLC has received FDA approval for its generic gabapentin o...

Eugia
FDA Approves TRANEXAMIC ACID — Eugia US LLC

Eugia US LLC received FDA approval for its ANDA for tranexamic acid intravenous injection (2016), a generic version of the marketed hemostatic agent. ...

Macleods
FDA Approves LEVOCETIRIZINE DIHYDROCHLORIDE — Macleods Pharmaceuticals Limited

# FDA Approves Macleods Pharmaceuticals' Generic Levocetirizine Dihydrochloride Macleods Pharmaceuticals Limited received FDA approval for its generi...

MYLAN
FDA Approves Unknown Drug — MYLAN

Mylan has received regulatory approval from the FDA for a new generic product through ANDA 205257, signaling a potential new revenue opportunity for t...

Actelion
FDA Approves UPTRAVI — Actelion Pharmaceuticals US, Inc.

# FDA Approves Actelion Pharmaceuticals' UPTRAVI for Pulmonary Arterial Hypertension Actelion Pharmaceuticals US, Inc. received FDA approval for UPTR...

Lupin
FDA Approves MORPHINE SULFATE — Lupin Pharmaceuticals,Inc.

Lupin Pharmaceuticals, Inc. announced that the FDA approved its Abbreviated New Drug Application (ANDA) for Morphine Sulfate Oral Solution, offering a...

Aurobindo
FDA Approves RISEDRONATE SODIUM — Aurobindo Pharma Limited

Aurobindo Pharma received FDA approval for its generic Risedronate Sodium oral tablets, opening a new revenue opportunity within the osteoporosis mark...

BioDelivery
FDA Approves BELBUCA — BioDelivery Sciences International Inc

BioDelivery Sciences International Inc. announced the FDA approval of BELBUCA, a buccal film intended for the management of moderate to severe chronic...

WG
FDA Approves DEXMEDETOMIDINE — WG Critical Care, LLC

# FDA Approves WG Critical Care's Dexmedetomidine Injection for Intravenous Use WG Critical Care, LLC has received FDA approval for its intravenous d...

Apotex
FDA Approves IBANDRONATE SODIUM — Apotex Corp.

# FDA Approves Apotex's Generic Ibandronate Sodium Injection Apotex Corp. received FDA approval for its generic ibandronate sodium intravenous formul...

Aurolife
FDA Approves METHADONE HYDROCHLORIDE — Aurolife Pharma, LLC

# FDA Approves Aurolife Pharma's Generic Methadone Hydrochloride Aurolife Pharma, LLC has received FDA approval for its generic methadone hydrochlori...

Boehringer
FDA Approves SYNJARDY — Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc. announced the FDA approval of SYNJARDY (empagliflozin and metformin hydrochloride tablets), combining two w...