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East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg. Aurobindo Pharma’s Ibuprofen and Famotidine Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Duexis® Tablets manufactured by Horizon Medicines LLC. Ibuprofen […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Sapropterin Dihydrochloride Tablets, 100 mg. Aurobindo Pharma’s Sapropterin Dihydrochloride Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Kuvan Tablets manufactured by BioMarin Pharmaceutical Inc. Sapropterin Dihydrochloride Tablets are […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Acetazolamide Tablets USP, 125 mg and 250 mg. Aurobindo Pharma’s Acetazolamide Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Diamox Tablets manufactured by Teva Branded Pharmaceutical Products R&D […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg. Aurobindo Pharma’s Dabigatran Etexilate Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Pradaxa Capsules manufactured by Boehringer Ingelheim […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Varenicline Tablets, 0.5 mg and 1 mg. Aurobindo Pharma’s Varenicline Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Chantix Tablets manufactured by PF Prism C.V. Varenicline Tablets are […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Oxcarbazepine Extended-Release Tablets, 150 mg, 300 mg, and 600 mg. Aurobindo Pharma’s Oxcarbazepine Extended-Release Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Oxtellar XR Tablets manufactured by Supernus […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg. Aurobindo Pharma’s Chlorpromazine Hydrochloride Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Chlorpromazine […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Esomeprazole Magnesium for Delayed-Release Oral Suspension, 10 mg. Aurobindo Pharma’s Esomeprazole Magnesium for Delayed-Release Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), Nexium for Delayed-Release Oral Suspension […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Esomeprazole Magnesium for Delayed-Release Oral Suspension, 5 mg, 20 mg, and 40 mg. Aurobindo Pharma’s Esomeprazole Magnesium for Delayed-Release Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Allopurinol Tablets USP, 100 mg and 300 mg. Aurobindo Pharma’s Allopurinol Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Zyloprim Tablets manufactured by Casper Pharma LLC. Allopurinol Tablets […]

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

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Dapsone Gel, 5%. Aurobindo Pharma’s Dapsone Gel, are an AB-rated generic equivalent to the reference listed drug (RLD), Aczone Gel manufactured by AbbVie Inc. Dapsone Gel are indicated for the: Topical treatment […]