All Product News

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Prednisone Tablets USP, 1mg. Aurobindo Pharma’s Prednisone Tablets USP, 1mg, are an AB-rated generic equivalent to the reference listed drug (RLD), Meticorten® Tablets, of Schering Corp Sub Schering Plough Corp. Prednisone 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 Vigabatrin for Oral Solution USP, 500 mg . Aurobindo Pharma’s Vigabatrin for Oral Solution USP, 500 mg are an AB-rated generic equivalent to the reference listed drug (RLD), Sabril for Oral Solution of […]

East Windsor, N.J. –Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Fenofibrate Capsules USP, 67mg, 134mg, and 200mg. Aurobindo Pharma’s Fenofibrate Capsules USP, 67mg, 134mg, and 200mg are an AB-rated generic equivalent to the reference listed drug (RLD), Tricor Capsules of AbbVie, Inc. Fenofibrate […]

East Windsor, N.J. –Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Memantine Hydrochloride Extended-Release Capsules, 7mg, 14mg, 21mg, and 28mg. Aurobindo Pharma’s Memantine Hydrochloride Extended-Release Capsules, 7mg, 14mg, 21mg, and 28mg are an AB-rated generic equivalent to the reference listed drug (RLD), Namenda XR […]

East Windsor, N.J. –Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Nifedipine Extended-Release Tablets USP, 30 mg, 60mg and 90 mg. Aurobindo Pharma’s Nifedipine Extended-Release Tablets, 30 mg, 60mg, and 90 mg are an AB-rated generic equivalent to the reference listed drug (RLD), ADALAT® CC of Alvogen […]

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

East Windsor, N.J. –Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, 2% / 0.5% (10 mL bottles). Aurobindo Pharma’s Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, are an AT-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 Potassium Chloride Extended-Release Tablets USP, 10 mEq, 15 mEq, and 20 mEq. Aurobindo Pharma’s Potassium Chloride Extended Release Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Potassium Chloride Extended […]

East Windsor, N.J. –Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Leflunomide Tablets USP, 10 mg and 20 mg. Aurobindo Pharma’s Leflunomide Tablets USP, are an AB-rated generic equivalent to the reference listed drug (RLD), Arava® Tablets marketed by Sanofi-aventis U.S. LLC. Leflunomide 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 Droxidopa Capsules, 100mg, 200mg, and 300mg. Aurobindo Pharma’s Droxidopa Capsules, 100mg, 200mg, and 300mg are an AB-rated generic equivalent to the reference listed drug (RLD), Northera® Capsules 100mg, 200mg, and 300mg marketed by Lundbeck NA Ltd.  Droxidopa Capsules 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 Tobramycin Inhalation Solution, 300 mg/5 mL. Aurobindo Pharma’s Tobramycin Inhalation Solution, 300 mg/5 mL are an AB-rated generic equivalent to the reference listed drug (RLD), Tobi® Inhalation Solution, 300 mg/5 mL marketed […]

East Windsor, N.J. – Aurobindo Pharma Limited has acquired Clorazepate Dipotassium Tablets 3.75mg, 7.5mg and 15mg from Mylan Pharmaceuticals Inc., a Viatris Company. Mylan has agreed to transfer the FDA-approved ANDA for each of these products to Aurobindo Pharma USA, Inc. and Aurobindo will begin to market, distribute, and sell these products as of January 1, […]