Generic Companies with Tentative Approvals for: lamotrigine
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lamotrigine 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 |
---|---|---|---|---|
Caraco | lamotrigine | 077757 | 100MG | TABLET; ORAL |
Roxane | lamotrigine | 077392 | 100MG | TABLET;ORAL |
Dr Reddys Labs Ltd | lamotrigine | 202383 | 25MG | TABLET, EXTENDED RELEASE;ORAL |
Roxane | lamotrigine | 077392 | 150MG | TABLET;ORAL |
Dr Reddys Labs Ltd | lamotrigine | 202383 | 300MG | TABLET, EXTENDED RELEASE;ORAL |
Dr Reddys Labs Ltd | lamotrigine | 202383 | 200MG | TABLET, EXTENDED RELEASE;ORAL |
Roxane | lamotrigine | 077392 | 25MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |