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FDA · 14,273 results Live
FDA PHARMOBEDIENT Apr 28 — 0.00

FDA Approves Unknown Drug — PHARMOBEDIENT

Pharmobedient Continues Regulatory Expansion Pharmobedient has expanded its product portfolio with this latest FDA approval, positioning itself for broader market penetration withi…

FDA Aurolife Apr 26 — 0.00

FDA Approves OXYMORPHONE HYDROCHLORIDE — Aurolife Pharma, LLC

Aurolife Pharma, LLC announced the FDA approval of its OxyMORPHONE HYDROCHLORIDE tablets, increasing generic availability in the opioid market and facilitating price competition ag…

FDA Collegium Apr 26 — 0.00

FDA Approves XTAMPZA ER — Collegium Pharmaceutical, Inc.

Collegium Pharmaceutical, Inc. capitalized on the FDA's April 26, 2016 approval of its XTAMPZA ER extended-release opioid, positioning itself for significant revenue growth within …

FDA AMNEAL Apr 22 — 0.00

FDA Approves Unknown Drug — AMNEAL PHARMS

# FDA Approves Amneal Pharmaceuticals Generic Drug Application Amneal Pharmaceuticals received FDA approval for ANDA205081 on April 22, 2016, expanding its generic drug portfolio …

FDA Sandoz Apr 19 — 0.00

FDA Approves MEROPENEM — Sandoz Inc

# FDA Approves Sandoz's Generic Meropenem for Intravenous Use Sandoz Inc. has received FDA approval for its generic meropenem injection, expanding the competitive landscape in the…

FDA Amneal Apr 12 — 0.00

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 generic morphine sulfate oral…

FDA AbbVie Apr 11 — 0.00

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 BCL-2 inhibitor for chronic l…

FDA Amneal Mar 17 — 0.00

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 oral formulation, expanding trea…

FDA ScieGen Feb 18 — 0.00

FDA Approves GABAPENTIN — ScieGen Pharmaceuticals, Inc.

# FDA Approves ScieGen Pharmaceuticals' Generic Gabapentin ScieGen Pharmaceuticals, Inc. received FDA approval for its generic gabapentin oral formulation, marking another entry i…

FDA Sagent Feb 17 — 0.00

FDA Approves FLUOROURACIL — Sagent Pharmaceuticals

# FDA Approves Sagent Pharmaceuticals' Generic Fluorouracil Injection Sagent Pharmaceuticals has received FDA approval for its generic fluorouracil intravenous formulation, expand…

FDA ACCORD Feb 5 — 0.00

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), expanding the company's gen…

FDA Creekwood Feb 4 — 0.00

FDA Approves GABAPENTIN — Creekwood Pharmaceuticals LLC

# FDA Approves Generic Gabapentin from Creekwood Pharmaceuticals Creekwood Pharmaceuticals LLC has received FDA approval for its generic gabapentin oral formulation, expanding the…

FDA Eugia Jan 14 — 0.00

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. This clearance expands generic…

FDA Macleods Jan 11 — 0.00

FDA Approves LEVOCETIRIZINE DIHYDROCHLORIDE — Macleods Pharmaceuticals Limited

# FDA Approves Macleods Pharmaceuticals' Generic Levocetirizine Dihydrochloride Macleods Pharmaceuticals Limited received FDA approval for its generic levocetirizine dihydrochlori…

FDA Actelion Dec 21 — 0.00

FDA Approves UPTRAVI — Actelion Pharmaceuticals US, Inc.

# FDA Approves Actelion Pharmaceuticals' UPTRAVI for Pulmonary Arterial Hypertension Actelion Pharmaceuticals US, Inc. received FDA approval for UPTRAVI (selexipag), an oral medic…

FDA Aurobindo Nov 30 — 0.00

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 market. This clearance allows the …

FDA BioDelivery Oct 23 — 0.00

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 pain that positions the compa…

FDA WG Oct 21 — 0.00

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 dexmedetomidine hydrochloride f…

FDA Apotex Oct 16 — 0.00

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 formulation, expanding the competiti…

FDA Aurolife Aug 31 — 0.00

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 hydrochloride oral formulation, expanding…