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January 02, 2025


Aurobindo Receives FDA Approval for Glycopyrrolate Oral Solution, 1 mg/5 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 Glycopyrrolate Oral Solution, 1 mg/5 mL. Aurobindo Pharma’s Glycopyrrolate Oral Solution, are an AB-rated generic equivalent to the reference listed drug (RLD), Cuvposa® Oral Solution manufactured by Merz Pharmaceuticals, LLC. Glycopyrrolate Oral […]

December 26, 2024


Aurobindo Receives FDA Approval for Deutetrabenazine Tablets, 6 mg, 9 mg, and 12 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 Deutetrabenazine Tablets, 6 mg, 9 mg, and 12 mg. Aurobindo Pharma’s Deutetrabenazine Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Austedo® Tablets manufactured by Teva Branded Pharmaceuticals Products […]

December 12, 2024


Aurobindo Receives FDA Approval for Clozapine Orally Disintegrating Tablets, 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 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 Clozapine Orally Disintegrating Tablets, 12.5 mg, 25 mg, 100 mg, 150 mg, and 200 mg. Aurobindo Pharma’s Clozapine Orally Disintegrating Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), […]

November 12, 2024


Aurobindo Receives FDA Approval for Cimetidine Tablets USP, 200 mg, 300 mg, 400 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 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 […]

October 15, 2024


Aurobindo Receives FDA Approval for Metronidazole Gel USP, 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 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 […]

September 27, 2024


Aurobindo Receives FDA Approval for Cephalexin Tablets USP, 250 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 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 […]

September 26, 2024


Aurobindo Receives FDA Approval for Mycophenolate Mofetil for Oral Suspension USP, 200 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 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 […]

August 02, 2024


Aurobindo Receives FDA Approval for Estradiol Vaginal Inserts USP, 10 mcg

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 […]

July 25, 2024


Aurobindo Receives FDA Approval for Doxepin Tablets, 3 mg and 6 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 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 […]

July 22, 2024


Aurobindo Receives FDA Approval for Baricitinib Tablets, 1 mg and 2 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 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 […]

July 18, 2024


Aurobindo Receives FDA Approval for Posaconazole Delayed-Release Tablets, 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 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 […]

July 18, 2024


Aurobindo Receives FDA Approval for Dutasteride and Tamsulosin Hydrochloride Capsules USP, 0.5 mg/0.4 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 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 […]