East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Solifenacin Succinate Tablets, 5mg, and 10mg. Aurobindo Pharma’s Solifenacin Succinate Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), VESIcare® Tablets, manufactured by Astellas Pharma US, Inc. Solifenacin Succinate […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Ursodiol Capsules USP, 300mg. Aurobindo Pharma’s Ursodiol Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Actigall® Capsules, manufactured by Teva Branded Pharmaceutical Products R&D, Inc. Ursodiol 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 Carbidopa and Levodopa Tablets USP, 10mg/100mg, 25mg/100mg, and 25mg/250mg. Aurobindo Pharma’s Carbidopa and Levodopa Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), SINEMET® Tablets, manufactured by ORGANON, LLC. Carbidopa

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Valganciclovir for Oral Solution, 50mg/mL. Aurobindo Pharma’s Valganciclovir for Oral Solution, are an AB-rated generic equivalent to the reference listed drug (RLD), VALCYTE® for oral solution 50mg/1mL, manufactured by HOFFMANN LA ROCHE

Aurobindo Pharma USA, Inc.: Contact 1-866-850-2876 (Option 2) Recall being handled by Qualanex: Contact 1-888-504-2014 FOR IMMEDIATE RELEASE – October 28, 2022– East Windsor, New Jersey, Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two (2) lots (refer table below) of combination project, Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Dicloxacillin Sodium Capsules USP, 250mg and 500mg. Aurobindo Pharma’s Dicloxacillin Sodium Capsules are an AB-rated generic equivalent to the reference listed drug (RLD), Pathocil® Capsules, manufactured by Wyeth Ayerst Laboratories. Dicloxacillin Sodium

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Exemestane Tablets USP, 25 mg.  Aurobindo Pharma’s Exemestane Tablets are an AB-rated generic equivalent to the reference listed drug (RLD), AROMASIN® tablets, manufactured by Pfizer Inc, USA.   Exemestane 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 Vigabatrin Tablets USP, 500 mg.  Aurobindo Pharma’s Vigabatrin Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), SABRIL® tablets, manufactured by Lundbeck Pharmaceuticals LLC.  Vigabatrin Tablets are indicated for: Adjunctive

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Acyclovir Oral Suspension USP, 200 mg/5 mL. Aurobindo Pharma’s Acyclovir Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), ZOVIRAX ® (acyclovir), of Mylan Pharmaceuticals Inc. Acyclovir Oral Suspension

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Bromfenac Ophthalmic Solution 0.09%. Aurobindo Pharma’s Bromfenac Ophthalmic Solution, are an AT-rated generic equivalent to the reference listed drug (RLD), Bromday™ Ophthalmic Solution, of Bausch & Lomb. Bromfenac Ophthalmic Solution are indicated for: Postoperative inflammation and reduction 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 Clobazam Oral Suspension, 2.5mg/mL. Aurobindo Pharma’s Clobazam Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), ONFI® Oral Suspension, of Lundbeck Pharmaceuticals LLC . Clobazam Oral Suspension  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 Colchicine Tablets USP, 0.6 mg. Aurobindo Pharma’s Colchicine Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), COLCRYS® Tablets, of Takeda Pharmaceuticals USA, Inc. Colchicine Tablets are indicated in: