Generic Companies with Tentative Approvals for: dapagliflozin;metformin hydrochloride
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dapagliflozin;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 |
---|---|---|---|---|
Teva Pharms Usa Inc | dapagliflozin;metformin hydrochloride | 211583 | 10MG/1000MG | TABLET, EXTENDED RELEASE;ORAL |
Teva Pharms Usa Inc | dapagliflozin;metformin hydrochloride | 211583 | 5MG/500MG | TABLET, EXTENDED RELEASE;ORAL |
Teva Pharms Usa Inc | dapagliflozin;metformin hydrochloride | 211583 | 5MG/1000MG | TABLET, EXTENDED RELEASE;ORAL |
Teva Pharms Usa Inc | dapagliflozin;metformin hydrochloride | 211583 | 2.5MG/1000MG | TABLET, EXTENDED RELEASE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |