FDA Approves Unknown Drug — GRAVITI PHARMS
# FDA Approves Generic Drug Application for Graviti Pharms Graviti Pharms has received FDA approval for ANDA201380, marking the company's entry into the generic pharmaceutical mar…
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# FDA Approves Generic Drug Application for Graviti Pharms Graviti Pharms has received FDA approval for ANDA201380, marking the company's entry into the generic pharmaceutical mar…
Aurolife Pharma, LLC received FDA approval for its Abbreviated New Drug Application for hydrocodone bitartrate and acetaminophen tablets on a recent date, likely increasing generic…
Apotex Inc. received FDA approval for Abbreviated New Drug Application (ANDA) #091308, signaling its entry into the market with a generic alternative that is anticipated to increas…
# FDA Approves Teva's Generic Irbesartan and Hydrochlorothiazide Combination Teva Pharmaceuticals USA, Inc. received FDA approval for a generic version of the irbesartan and hydro…
ALKEM LABS LTD secured an FDA approval for ANDA202076, a regulatory milestone expected to bolster the company's market presence and unlock significant commercial potential for its …
On March 28, 2012, Northstar Rx LLC won FDA approval of its ANDA for the combined oral contraceptive ELINEST (norgestrel and ethinyl estradiol), positioning the manufacturer to com…
# FDA Approves Generic Ibandronate Sodium from Bionpharma Inc. Bionpharma Inc. has received FDA approval for its generic ibandronate sodium oral formulation, expanding treatment o…
# FDA Approves ANDA for PHARMOBEDIENT PHARMOBEDIENT has received FDA approval for ANDA078995, marking the company's entry into an additional generic drug market and expanding its …
# FDA Approves Hope Pharmaceuticals' Sodium Thiosulfate Injection Hope Pharmaceuticals received FDA approval for sodium thiosulfate intravenous injection on February 14, 2012, mar…
Merck Sharp & Dohme has received FDA approval for JANUMET XR, merging sitagliptin and metformin into an once-daily formulation expected to heighten market rivalry and streamline tr…
# FDA Approves Vertex Pharmaceuticals' KALYDECO for Cystic Fibrosis Vertex Pharmaceuticals Incorporated received FDA approval for KALYDECO (ivacaftor), an oral medication represen…
On January 30, 2012, Boehringer Ingelheim Pharmaceuticals, Inc. received FDA approval for JENTADUETO (linagliptin and metformin hydrochloride) oral tablets, combining the DPP-4 inh…
GENUS Pharmaceuticals received FDA approval for its Abbreviated New Drug Application (ANDA 200343), a development poised to bolster the manufacturer's market position and revenue p…
# FDA Approves Mayne Pharma's Generic Isotretinoin Mayne Pharma received FDA approval for its generic isotretinoin oral formulation (ANDA076485) on January 19, 2012, marking anoth…
Hikma Pharmaceuticals USA Inc. received FDA approval for its intravenous ARGATROBAN application in January 2012, broadening its product portfolio of anticoagulants and strengthenin…
Alvogen, Inc. announced FDA approval for its Abbreviated New Drug Application (ANDA202116) to manufacture generic oxycodone hydrochloride tablets, signaling the company’s strategic…
Sun Pharmaceutical Industries, Inc. received FDA approval to market the generic version of TRAMADOL HYDROCHLORIDE oral tablets, continuing the company's strategic push into the exp…
Sun Pharmaceutical Industries, Inc. has received FDA approval for its Abbreviated New Drug Application for the oral formulation of TRAMADOL HYDROCHLORIDE, positioning the company t…
APOTEX received FDA approval December 7, 2011, for a new product, signaling a strategic expansion of its product portfolio. This regulatory milestone positions the company to compe…
# FDA Approves ANDA for Strides Pharma Strides Pharma has received FDA approval for ANDA 202075, expanding its generic drug portfolio and positioning the company to capture market…