Generic Companies with Tentative Approvals for: metformin hydrochloride
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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 |
---|---|---|---|---|
Anchen Pharms | metformin hydrochloride; sitagliptin phosphate | 204144 | 500MG; EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL |
Msn Labs Pvt Ltd | metformin hydrochloride | 211479 | 5MG; 500MG | TABLET, EXTENDED RELEASE; ORAL |
Msn Labs Pvt Ltd | metformin hydrochloride | 211479 | 10MG; 500MG | TABLET, EXTENDED RELEASE; ORAL |
Zydus Pharms Usa Inc | metformin hydrochloride;sitagliptin phosphate | 208535 | 50MG/500MG;50MG/1000MG | TABLET;ORAL |
Anchen Pharms | metformin hydrochloride; sitagliptin phosphate | 204144 | 1GM; EQ 50MG BASE | TABLET, EXTENDED RELEASE;ORAL |
Ranbaxy Labs Ltd | metformin hydrochloride | 076413 | 500MG | TABLET, EXTENDED RELEASE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |