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 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, […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Ketorolac Tromethamine Ophthalmic Solution, 0.5%. Aurobindo Pharma’s Ketorolac Tromethamine Ophthalmic Solution, 0.5% are an AB-rated generic equivalent to the reference listed drug (RLD), Acular® Ophthalmic Solution, 0.5% (Allergan, Inc.) Ketorolac Tromethamine Ophthalmic […]

East Windsor, N.J. – Aurobindo Pharma’s JV, Eugia Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Tamoxifen Citrate Tablets USP, 10 mg and 20 mg. Aurobindo’s  JV, Eugia Pharma Tamoxifen Citrate Tablets USP, 10 mg and 20 mg. are an AB-rated generic equivalent to the reference listed drug (RLD), Nolvadex® 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 Methocarbamol Tablets USP, 750 mg. Aurobindo’s Methocarbamol Tablets USP, 750 mg are an AB-rated generic equivalent to the reference listed drug (RLD), Robaxin-750® Tablets of Auxilium Pharmaceuticals, LLC. Methocarbamol Tablets are indicated for: Indicated as an adjunct […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg.  Aurobindo’s Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg, are an AB-rated generic equivalent to the reference listed drug (RLD), ProAmatine 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 Anastrozole Tablets USP, 1 mg. Aurobindo’s Anastrozole Tablets USP, 1 mg are an AB-rated generic equivalent to the reference listed drug (RLD), Arimidex Tablets, 1 mg, of ANI Pharmaceuticals, Inc. Anastrozole 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 Imatinib Mesylate Tablets, 100 mg and 400 mg. Aurobindo’s Imatinib Mesylate Tablets, 100 mg and 400 mg are an AB-rated generic equivalent to the reference listed drug (RLD), Gleevec Tablets, 100 mg […]