Generic Companies with Tentative Approvals for: nintedanib
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nintedanib 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 |
---|---|---|---|---|
Lotus Pharm Co Ltd | nintedanib | 216915 | 150MG | CAPSULE;ORAL |
Glenmark Pharms Ltd | nintedanib esylate | 212555 | EQ 150MG BASE | CAPSULE;ORAL |
Accord Hlthcare Inc | nintedanib | 212732 | EQ 150MG BASE | CAPSULE;ORAL |
Lotus Pharm Co Ltd | nintedanib | 216915 | 100MG | CAPSULE;ORAL |
Eugia Pharma Speclts | nintedanib | 215123 | EQ 150MG BASE | CAPSULE;ORAL |
Accord Hlthcare Inc | nintedanib | 212732 | EQ 100MG BASE | CAPSULE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |