Generic Companies with Tentative Approvals for: gabapentin
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gabapentin 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 |
---|---|---|---|---|
Glenmark Pharms Ltd | gabapentin encarbil | 213501 | 300MG | TABLET, EXTENDED RELEASE;ORAL |
Glenmark Pharms Ltd | gabapentin encarbil | 213501 | 600MG | TABLET, EXTENDED RELEASE;ORAL |
Actavis Elizabeth | gabapentin | 203611 | 600MG | TABLET; ORAL |
Actavis Elizabeth | gabapentin | 203611 | 300MG | TABLET; ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |