Generic Companies with Tentative Approvals for: topiramate
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topiramate Generic Filers with Tentative Approvals
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
| Applicant | Generic Name | NDA | Strength | Dosage Form |
|---|---|---|---|---|
| Barr | topiramate | 076315 | 100MG | TABLET;ORAL |
| Supernus Pharms | topiramate | 201635 | 50MG | CAPSULE, EXTENDED RELEASE;ORAL |
| Barr | topiramate | 076315 | 25MG | TABLET;ORAL |
| Roxane | topiramate | 076306 | 50MG | TABLET;ORAL |
| Supernus Pharms | topiramate | 201635 | 200MG | CAPSULE, EXTENDED RELEASE;ORAL |
| Roxane | topiramate | 076306 | 100MG | TABLET;ORAL |
| >Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |
