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December 06, 2023


Aurobindo Receives FDA Approval for Oshih (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 mg/20 mcg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Oshih (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 mg/20 mcg. Aurobindo Pharma’s Oshih (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), are an AB-rated […]

November 28, 2023


Aurobindo Receives FDA Approval for Darunavir Tablets, 600 mg and 800 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Darunavir Tablets, 600 mg and 800 mg. Aurobindo Pharma’s Darunavir Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Prezista Tablets manufactured by Janssen Products, L.P. Darunavir Tablets are […]

November 27, 2023


Aurobindo Receives FDA Approval for Zafirlukast Tablets, 10 mg and 20 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Zafirlukast Tablets, 10 mg and 20 mg. Aurobindo Pharma’s Zafirlukast Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Accolate Tablets manufactured by Strides Pharma Global Pte. Limited. Zafirlukast […]

October 31, 2023


Aurobindo Receives FDA Approval for Ampicillin Capsules USP, 250 mg and 500 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Ampicillin Capsules USP, 250 mg and 500 mg. Aurobindo Pharma’s Ampicillin Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Principen Capsules manufactured by Apothecon Inc. Ampicillin Capsules are […]

October 26, 2023


Aurobindo Receives FDA Approval for Nitroglycerin Sublingual Tablets, USP, 0.3 mg, 0.4 mg, and 0.6 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Nitroglycerin Sublingual Tablets, USP, 0.3 mg, 0.4 mg, and 0.6 mg. Aurobindo Pharma’s Nitroglycerin Sublingual Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Nitrostat® Sublingual Tablets manufactured by […]

October 25, 2023


Aurobindo Receives FDA Approval for Febuxostat Tablets, 40 mg and 80 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Febuxostat Tablets, 40 mg and 80 mg. Aurobindo Pharma’s Febuxostat Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Uloric Tablets manufactured by Takeda Pharmaceuticals U.S.A., Inc. Febuxostat Tablets […]

October 16, 2023


Aurobindo Receives FDA Approval for Deferasirox Tablets, 90 mg, 180 mg, and 360 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Deferasirox Tablets, 90 mg, 180 mg, and 360 mg. Aurobindo Pharma’s Deferasirox Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Jadenu® Tablets manufactured by Novartis Pharmaceuticals Corporation. Deferasirox […]

September 27, 2023


Aurobindo Receives FDA Approval for Topiramate Capsules USP, 15 mg and 25 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Topiramate Capsules USP, 15 mg and 25 mg. Aurobindo Pharma’s Topiramate Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Topamax® Sprinkle Capsules manufactured by Janssen Pharmaceuticals, Inc. Topiramate […]

September 14, 2023


Aurobindo Receives FDA Approval for Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg. Aurobindo Pharma’s Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Librax® Capsules manufactured […]

September 06, 2023


Aurobindo Receives FDA Approval for Loperamide Hydrochloride Capsules USP 2mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Loperamide Hydrochloride Capsules USP, 2mg. Aurobindo Pharma’s Loperamide Hydrochloride Capsules are an AB-rated generic equivalent to the reference listed drug (RLD),  Imodium® Capsules, manufactured by Johnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division. Loperamide Hydrochloride […]

August 18, 2023


Aurobindo Receives FDA Approval for Fluphenazine Hydrochloride Tablets 1mg, 2.5mg, 5mg, and 10mg 

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Fluphenazine Hydrochloride Tablets 1mg, 2.5mg, 5mg, and 10mg. Aurobindo Pharma’s Fluphenazine Hydrochloride Tablets are an AB-rated generic equivalent to the reference listed drug (RLD), Prolixin Tablets manufactured by Apothecon Inc. Fluphenazine Hydrochloride Tablets are indicated for : […]

July 31, 2023


Aurobindo Receives FDA Approval for Saxagliptin Tablets, 2.5mg and 5mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Saxagliptin Tablets. Aurobindo Pharma’s Saxagliptin Tablets are an are an AB-rated generic equivalent to the reference listed drug (RLD),Onglyza Tablets, manufactured by AstraZeneca AB. Saxagliptin Tablets, are indicated for : An adjunct […]