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Generic Companies with Tentative Approvals for: Roxane
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Roxane 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 |
---|---|---|---|---|
Roxane | lamotrigine | 077392 | 100MG | TABLET;ORAL |
Roxane | topiramate | 076306 | 200MG | TABLET;ORAL |
Roxane | sumatriptan succinate | 078241 | EQ 50MG BASE | TABLET;ORAL |
Roxane | lisdexamfetamine dimesylate | 202827 | 20MG | CAPSULE;ORAL |
Roxane | tapentadol | 205057 | 75MG | TABLET;ORAL |
Roxane | topiramate | 076306 | 50MG | TABLET;ORAL |
Roxane | lisdexamfetamine dimesylate | 202827 | 60MG | CAPSULE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |