Generic Companies with Tentative Approvals for: dapagliflozin
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dapagliflozin 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 |
---|---|---|---|---|
Glenmark Generics | dapagliflozin | 211564 | 10MG | TABLET;ORAL |
Lupin Ltd | dapagliflozin, saxagliptin monohydrate | 211532 | 5MG | TABLET; ORAL |
Lupin Ltd | dapagliflozin, saxagliptin monohydrate | 211532 | 10MG | TABLET; ORAL |
Zydus Pharms | dapagliflozin | 211582 | 5MG | TABLET;ORAL |
Astrazeneca Ab | dapagliflozin; metformin hydrochloride | 205649 | 5MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
Apotex Inc | dapagliflozin | 211442 | 5MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |