Generic Companies with Tentative Approvals for: empagliflozin;metformin hydrochloride
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empagliflozin;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 |
---|---|---|---|---|
Lupin Ltd | empagliflozin;metformin hydrochloride | 213654 | 10MG; 1GM | TABLET, EXTENDED RELEASE;ORAL |
Msn Labs Pvt Ltd | empagliflozin;metformin hydrochloride | 212362 | 10MG/1000MG | TABLET, EXTENDED RELEASE; ORAL |
Prinston Pharma Inc | empagliflozin;metformin hydrochloride | 218483 | 12.5MG;1000MG | TABLET;ORAL |
Msn Labs Pvt Ltd | empagliflozin;metformin hydrochloride | 212362 | 12.5MG/1000MG | TABLET, EXTENDED RELEASE; ORAL |
Msn Labs Pvt Ltd | empagliflozin;metformin hydrochloride | 212362 | 5MG/1000MG | TABLET, EXTENDED RELEASE; ORAL |
Msn Labs Pvt Ltd | empagliflozin;metformin hydrochloride | 212362 | 25MG/1000MG | TABLET, EXTENDED RELEASE; ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |