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FDA · 22,676 results Live
FDA SUN Apr 10 — 0.00

FDA Approves Unknown Drug — SUN PHARM INDS INC

# FDA Approves Generic Drug Application for Sun Pharmaceutical Industries Sun Pharmaceutical Industries Inc. received FDA approval for an abbreviated new drug application (ANDA090…

FDA Novartis Mar 30 — 0.00

FDA Approves AFINITOR — Novartis Pharmaceuticals Corporation

# FDA Approves Novartis's Afinitor (Everolimus) for Oncology Treatment Novartis Pharmaceuticals Corporation received FDA approval for Afinitor (everolimus), an oral mTOR inhibitor…

FDA SUN Mar 27 — 0.00

FDA Approves Unknown Drug — SUN PHARM INDS LTD

# FDA Approves Sun Pharmaceutical's Generic Drug Application Sun Pharmaceutical Industries Ltd. received FDA approval for its abbreviated new drug application (ANDA076327) on Marc…

FDA Cipla Mar 27 — 0.00

FDA Approves TOPIRAMATE — Cipla USA Inc.

# FDA Approves Generic Topiramate from Cipla USA Inc. Cipla USA Inc. received FDA approval for its generic topiramate oral formulation on March 27, 2009, potentially expanding tre…

FDA PHARMOBEDIENT Mar 17 — 0.00

FDA Approves Unknown Drug — PHARMOBEDIENT

PHARMOBEDIENT announced Monday that it has received approval from the FDA for ANDA #090062, clearing the generic pathway for the generic version of the drug. The approval is expect…

FDA Sun Mar 9 — 0.00

FDA Approves LEUPROLIDE ACETATE — Sun Pharmaceutical Industries, Inc.

# FDA Approves Sun Pharmaceutical's Generic Leuprolide Acetate Sun Pharmaceutical Industries, Inc. received FDA approval for its generic leuprolide acetate formulation on March 9,…

FDA Glenmark Feb 19 — 0.00

FDA Approves LAMOTRIGINE — Glenmark Pharmaceuticals Inc., USA

Glenmark Pharmaceuticals Inc., USA secured final FDA approval for its generic Lamotrigine oral drug, clearing the path for a cost-effective market entry that is expected to drive c…

FDA Harrow Feb 13 — 0.00

FDA Approves TOBRADEX ST — Harrow Eye, LLC

# FDA Approves Harrow Eye's TOBRADEX ST for Ophthalmic Inflammation Harrow Eye, LLC has received FDA approval for TOBRADEX ST (tobramycin/dexamethasone), a combination ophthalmic …

FDA TARO Feb 4 — 0.00

FDA Approves Unknown Drug — TARO

# FDA Approves TARO's Generic Drug Application Taro Pharmaceutical Industries has received FDA approval for ANDA 079204, expanding its generic drug portfolio and positioning the c…

FDA SANDOZ Jan 29 — 0.00

FDA Approves Unknown Drug — SANDOZ

# FDA Approves Sandoz Generic Drug Application Sandoz received FDA approval for ANDA040719 on January 29, 2009, expanding its generic drug portfolio and positioning the company to…

FDA Mylan Jan 29 — 0.00

FDA Approves DIVALPROEX SODIUM — Mylan Pharmaceuticals Inc.

Mylan Pharmaceuticals Inc. secured FDA approval for its generic Divalproex Sodium, a substance used to treat epilepsy and bipolar disorder, positioning the company to capture marke…

FDA RISING Jan 27 — 0.00

FDA Approves Unknown Drug — RISING

# FDA Approves Rising's Generic Drug Application Rising Pharmaceuticals received FDA approval for its abbreviated new drug application (ANDA077420) on January 27, 2009, expanding …

FDA Aurobindo Jan 27 — 0.00

FDA Approves LAMOTRIGINE — Aurobindo Pharma Limited

Aurobindo Pharma Limited secured final FDA approval for its generic Lamotrigine oral tablets, a development anticipated to enhance the company's market share in the anticonvulsant …

FDA Advagen Jan 27 — 0.00

FDA Approves LAMOTRIGINE — Advagen Pharma Limited

Advagen Pharma Limited announced the FDA approval of its generic oral LAMOTRIGINE formulation under ANDA078625, granting the company immediate access to the established market for …

FDA Sun Jan 27 — 0.00

FDA Approves LAMOTRIGINE — Sun Pharmaceutical Industries, Inc.

Sun Pharmaceutical Industries, Inc. announced that the FDA approved its Abbreviated New Drug Application (ANDA078525) for oral lamotrigine, enabling the company to capitalize on th…

FDA OWP Jan 27 — 0.00

FDA Approves LAMOTRIGINE KIT — OWP Pharmaceuticals, Inc.

OWP Pharmaceuticals, Inc. received FDA approval for its multi-strength Lamotrigine oral kit, marking its entry into the antiepileptic market and enabling the company to compete wit…

FDA PHARMOBEDIENT Dec 24 — 0.00

FDA Approves Unknown Drug — PHARMOBEDIENT

# FDA Approves PHARMOBEDIENT ANDA Application PHARMOBEDIENT has received FDA approval for ANDA078190, marking the company's entry into an additional generic drug market and potent…

FDA SUN Dec 23 — 0.00

FDA Approves Unknown Drug — SUN PHARM INDS INC

Sun Pharma Industries Inc. announced FDA approval for its Isosorbide Mononitrate Extended-Release Tablets, expanding the generic giant's portfolio and offering a new competitive en…

FDA INDICUS Nov 25 — 0.00

FDA Approves Unknown Drug — INDICUS PHARMA

Indicator Pharma has secured FDA approval for its generic drug application, marking a potential commercial victory pending further specification of the approved substance. This cle…

FDA Hikma Nov 20 — 0.00

FDA Approves TAPENTADOL — Hikma Pharmaceuticals USA Inc.

Hikma Pharmaceuticals USA Inc. has secured approval for oral tapentadol, a generic version of NDA022304 set to expand its robust opioid portfolio alongside Nucynta. With the move t…