Product News Archives | Aurobindo Pharma USA

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September 25, 2026


Aurobindo Receives FDA Approval for Metronidazole Vaginal Gel, 0.75%

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Metronidazole Vaginal Gel, 0.75%. Aurobindo Pharma’s Metronidazole Vaginal Gel, are an AB-rated generic equivalent to the reference listed drug (RLD), MetroGel® Vaginal Gel, manufactured by Bausch Health US, LLC. Metronidazole Vaginal Gel […]

September 17, 2026


Aurobindo Receives FDA Approval for Cyclosporine Capsules USP (Modified) (Soft Gelatin Capsules), 25 mg, 50 mg, and 100 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 Cyclosporine Capsules USP (Modified) (Soft Gelatin Capsules), 25 mg, 50 mg, and 100 mg. Aurobindo Pharma’s Cyclosporine Capsules USP (Modified), are an AB-rated generic equivalent to the reference listed drug (RLD), Neoral® […]

September 10, 2026


Aurobindo Receives FDA Approval for Isotretinoin Capsules USP, 20 mg, 30 mg, and 40 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 Isotretinoin Capsules USP, 20 mg, 30 mg, and 40 mg. Aurobindo Pharma’s Isotretinoin Capsules USP, are an AB-rated generic equivalent to the reference listed drug (RLD), Accutane® Capsules, manufactured by Hoffmann La […]

September 02, 2026


Aurobindo Receives FDA Approval for Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 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 Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg. Aurobindo Pharma’s Sacubitril and Valsartan Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Entresto® […]

August 10, 2026


Aurobindo Receives FDA Approval for Brivaracetam Oral Solution, 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 Brivaracetam Oral Solution, 10 mg/mL. Aurobindo Pharma’s Brivaracetam Oral Solution, are an AB-rated generic equivalent to the reference listed drug (RLD), Briviact® Oral Solution, manufactured by UBC, Inc. Brivaracetam Oral Solution are […]

August 07, 2026


Aurobindo Receives FDA Approval for Vancomycin Hydrochloride for Oral Solution USP, 25 mg/mL and 50 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 Vancomycin Hydrochloride for Oral Solution USP, 25 mg/mL and 50 mg/mL. Aurobindo Pharma’s Vancomycin Hydrochloride for Oral Solution USP, are an AB-rated generic equivalent to the reference listed drug (RLD), Firvanq® for […]

August 05, 2026


Aurobindo Receives FDA Approval for Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 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 Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg and 800 mg. Aurobindo Pharma’s Eslicarbazepine Acetate Tablets,  are an AB-rated generic equivalent to the reference listed drug (RLD), Aptiom® Tablets, manufactured by […]

July 22, 2026


Aurobindo Receives FDA Approval for Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. Aurobindo Pharma’s Adapalene and Benzoyl Peroxide Topical Gel,  are an AB-rated generic equivalent to the reference listed drug (RLD), Epiduo® Forte Topical Gel, manufactured by […]

July 21, 2026


Aurobindo Receives FDA Approval for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 150 mg and 300 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 Bupropion Hydrochloride Extended-Release Tablets USP (XL), 150 mg and 300 mg. Aurobindo Pharma’s Bupropion Hydrochloride Extended-Release Tablets USP (XL),  are an AB-rated generic equivalent to the reference listed drug (RLD), Wellbutrin XL® […]

July 15, 2026


Aurobindo Receives FDA Approval for Etodolac Tablets USP, 400 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 Etodolac Tablets USP, 400 mg and 500 mg. Aurobindo Pharma’s Etodolac Tablets USP, are an AB-rated generic equivalent to the reference listed drug (RLD), Lodine® Tablets, manufactured by Wyeth Pharmaceuticals Inc. Etodolac […]

June 24, 2026


Aurobindo Receives FDA Approval for Icosapent Ethyl Capsules, 1 gram

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Icosapent Ethyl Capsules, 1 gram. Aurobindo Pharma’s Icosapent Ethyl Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Vascepa Capsules, manufactured by Amarin Pharmaceuticals Ireland, Limited. Icosapent Ethyl Capsules […]