Generic Companies with Tentative Approvals for: linagliptin; metformin hydrochloride
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linagliptin; 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 |
---|---|---|---|---|
Zydus Pharms Usa Inc | linagliptin; metformin hydrochloride | 208449 | 2.5MG;1GM | TABLET;ORAL |
Dr Reddys Labs Ltd | linagliptin; metformin hydrochloride | 208427 | 2.5MG; 850MG | TABLET;ORAL |
Zydus Pharms Usa Inc | linagliptin; metformin hydrochloride | 208449 | 2.5MG;500MG | TABLET;ORAL |
Prinston Pharma Inc | linagliptin; metformin hydrochloride | 208473 | 2.5MG;850MG | TABLET;ORAL |
Dr Reddys Labs Ltd | linagliptin; metformin hydrochloride | 208427 | 2.5MG; 500MG | TABLET;ORAL |
Dr Reddys Labs Ltd | linagliptin; metformin hydrochloride | 208427 | 2.5MG; 1G | TABLET;ORAL |
Zydus Pharms Usa Inc | linagliptin; metformin hydrochloride | 208449 | 2.5MG;850MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |