Generic Companies with Tentative Approvals for: esomeprazole magnesium; naproxen
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esomeprazole magnesium; naproxen 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 |
---|---|---|---|---|
Dr Reddys Labs Ltd | esomeprazole magnesium; naproxen | 202461 | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE;ORAL |
Dr Reddys Labs Ltd | esomeprazole magnesium; naproxen | 202461 | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |