Aurobindo Pharma gets final approval for Topiramate Tablets from USFDA
March 30, 2009 by admin
Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) for Topiramate Tablets 25mg, 50mg, 100mg and 200mg.
The tablets are the generic equivalent of Ortho McNeil Janssen Pharmaceutical’s Topamax Tablets 25mg, 50mg, 100mg. They are indicated for the treatment of epilepsy in both children and adults.
The company has a total of 94 ANDA approvals from USFDA. It includes 68 final approvals and 26 tentative approvals.
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