Generic Companies with Tentative Approvals for: empagliflozin
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empagliflozin 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 |
---|---|---|---|---|
Kinapse Limited | empagliflozin; linagliptin | 212354 | 10MG/5MG | TABLET; ORAL |
Lupin Ltd | empagliflozin;metformin hydrochloride | 213654 | 10MG; 1GM | TABLET, EXTENDED RELEASE;ORAL |
Lupin Ltd | empagliflozin;metformin hydrochloride | 213654 | 25MG; 1GM | TABLET, EXTENDED RELEASE;ORAL |
Alkem Labs Ltd | empagliflozin | 212382 | 10MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |