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January 24, 2024


Aurobindo Receives FDA Approval for Lacosamide Oral Solution USP, 10 mg/mL

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Lacosamide Oral Solution USP, 10 mg/mL. Aurobindo Pharma’s Lacosamide Oral Solution, are an AB-rated generic equivalent to the reference listed drug (RLD), VIMPAT® Oral Solution manufactured by UCB, Inc. Lacosamide Oral Solution […]

January 08, 2024


Aurobindo Receives FDA Approval for Enalapril Maleate Oral Solution, 1 mg/mL

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Enalapril Maleate Oral Solution, 1 mg/mL. Aurobindo Pharma’s Enalapril Maleate Oral Solution, are an AB-rated generic equivalent to the reference listed drug (RLD), Epaned® Oral Solution manufactured by Azurity Pharmaceuticals, Inc. Enalapril […]

January 05, 2024


Aurobindo Receives FDA Approval for Mycophenolate Mofetil Capsules USP, 250 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 Mycophenolate Mofetil Capsules USP, 250 mg. Aurobindo Pharma’s Mycophenolate Mofetil Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), CellCept Capsules manufactured by Roche Palo Alto LLC. Mycophenolate Mofetil […]

December 14, 2023


Aurobindo Receives FDA Approval for Diazepam Tablets USP, 2 mg, 5 mg and 10 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 Diazepam Tablets USP, 2 mg, 5 mg and 10 mg. Aurobindo Pharma’s Diazepam Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Valium Tablets manufactured by Waylis Therapeutics LLC. […]

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 […]