All 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 Lacosamide Tablets USP, 50mg, 100mg, 150mg and 200mg. Aurobindo Pharma’s Lacosamide Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), VIMPAT® Tablets manufactured by UCB, Inc.  Lacosamide 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 Dimethyl Fumarate Delayed-Release Capsules, 120mg and 240mg. Aurobindo Pharma’s Dimethyl Fumarate Delayed-Release Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), TECFIDERA® Delayed-Release Capsules manufactured by BIOGEN Inc. Dimethyl […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Sildenafil for Oral Suspension, 10mg/mL. Aurobindo Pharma’s Sildenafil for Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), Revatio® for oral suspension 10mg/mL manufactured by Viatris Specialty LLC.  […]

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Ranolazine Extended-Release Tablets, 500mg and 1000mg. Aurobindo Pharma’s Ranolazine Extended-Release Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), RANEXA® Extended-Release Tablets, manufactured by Gilead Sciences Inc. Ranolazine 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 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 […]