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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 Cimetidine Tablets USP, 200 mg, 300 mg, 400 mg, and 800 mg. Aurobindo Pharma’s Cimetidine Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Tagamet® Tablets manufactured by Glaxosmithkline […]

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 Gel USP, 1%. Aurobindo Pharma’s Metronidazole Gel, are an AB-rated generic equivalent to the reference listed drug (RLD), METROGEL® manufactured by Galderma Laboratories, L.P. Metronidazole Gel are indicated for: The topical […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Cephalexin Tablets USP, 250 mg and 500 mg. Aurobindo Pharma’s Cephalexin Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Keflet Tablets manufactured by Eli Lilly and Company. Cephalexin […]

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 for Oral Suspension USP, 200 mg/mL. Aurobindo Pharma’s Mycophenolate Mofetil for Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), CELLCEPT® Oral Suspension manufactured by Roche […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Estradiol Vaginal Inserts USP, 10 mcg. Aurobindo Pharma’s Estradiol Vaginal Inserts, are an AB-rated generic equivalent to the reference listed drug (RLD), Vagifem manufactured by Novo Nordisk Inc. Estradiol Vaginal Inserts 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 Doxepin Tablets, 3 mg and 6 mg. Aurobindo Pharma’s Doxepin Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Silenor Tablets manufactured by Currax Pharmaceuticals LLC. Doxepin 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 Baricitinib Tablets, 1 mg and 2 mg. Aurobindo Pharma’s Baricitinib Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Olumiant Tablets manufactured by Eli Lilly and Company. Baricitinib 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 Posaconazole Delayed-Release Tablets, 100 mg. Aurobindo Pharma’s Posaconazole Delayed-Release Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Noxafil Delayed-Release Tablets manufactured by Merck, Sharp & Dohme LLC. Posaconazole […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Dutasteride and Tamsulosin Hydrochloride Capsules USP, 0.5 mg/0.4 mg. Aurobindo Pharma’s Dutasteride and Tamsulosin Hydrochloride Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Jalyn Capsules manufactured by Waylis […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Levothyroxine Sodium Tablets USP, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Aurobindo Pharma’s Levothyroxine Sodium Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Synthroid […]

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

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Tofacitinib Extended-Release Tablets, 11 mg. Aurobindo Pharma’s Tofacitinib Extended-Release Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Xeljanz XR Extended-Release Tablets manufactured by Pfizer Inc. Tofacitinib Extended-Release Tablets […]