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 Macitentan Tablets, 10 mg. Aurobindo Pharma’s Macitentan Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), OPSUMIT® Tablets manufactured by Actelion Pharmaceuticals US, Inc. Macitentan Tablets are indicated for: […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Cevimeline Hydrochloride Capsules, 30 mg. Aurobindo Pharma’s Cevimeline Hydrochloride Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Evoxac® Capsules manufactured by Cosette Pharmaceuticals, Inc. Cevimeline Hydrochloride 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 Roflumilast Tablets, 500 mcg. Aurobindo Pharma’s Roflumilast Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), DALIRESP® Tablets manufactured by Astrazeneca Pharmaceuticals LP. Roflumilast Tablets are indicated as: A […]

Aurobindo Receives FDA Approval for Prednisolone Tablets USP, 5mg Aurobindo Receives FDA Approval for Prednisolone Tablets USP, 5mg East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Prazosin Hydrochloride Capsules USP, 1mg, 2mg and 5mg. Aurobindo Pharma’s Prazosin Hydrochloride Capsules, are an AB-rated generic equivalent to the reference listed […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Mesalamine Extended-Release Capsules USP, 0.375 g. Aurobindo Pharma’s Mesalamine Extended-Release Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Apriso Extended-Release Capsules manufactured by Salix Pharmaceuticals, Inc. Mesalamine Extended-Release […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) 100mg. Aurobindo Pharma’s Nitrofurantoin Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Macrobid® Capsules manufactured by Almatica Pharma, LLC.  Nitrofurantoin Capsules are indicated for: The treatment […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg. Aurobindo Pharma’s Pregabalin Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Lyrica® Capsules manufactured […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg and 30 mg. Aurobindo Pharma’s Lansoprazole Delayed-Release Orally Disintegrating Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), PREVACID® SoluTabTM Delayed-Release Orally Disintegrating 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 Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and 75 mg. Aurobindo Pharma’s Clomipramine Hydrochloride Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Anafranil Capsules manufactured by SpecGx […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Prednisolone Tablets USP, 5 mg. Aurobindo Pharma’s Prednisolone Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Prednisolone Tablets manufactured by Watson Laboratories Inc. Prednisolone Tablets are indicated in […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Emtricitabine Capsules, 200 mg. Aurobindo Pharma’s Emtricitabine Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Emtriva® (emtricitabine) Capsules manufactured by Gilead Sciences, Inc. Emtricitabine Capsules are indicated in: […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg. Aurobindo Pharma’s Lurasidone Hydrochloride Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), LATUDA® tablets […]