Generic Companies with Tentative Approvals for: sitagliptin; metformin hydrochloride
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sitagliptin; metformin hydrochloride 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 |
---|---|---|---|---|
Sandoz Inc | sitagliptin; metformin hydrochloride | 202388 | 50MG; 500MG | TABLET; ORAL |
Apotex Inc | sitagliptin; metformin hydrochloride | 202426 | 50MG; 500MG | TABLET; ORAL |
Ajanta Pharma Ltd | sitagliptin; metformin hydrochloride | 215220 | 50MG/1000MG | TABLET; ORAL |
Sandoz Inc | sitagliptin; metformin hydrochloride | 202388 | 50MG; 1000MG | TABLET; ORAL |
Apotex Inc | sitagliptin; metformin hydrochloride | 202426 | 50MG; 1000MG | TABLET; ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |