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Generic Companies with Tentative Approvals for: Mylan Labs
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Mylan Labs 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 |
---|---|---|---|---|
Mylan Labs Ltd | posaconazole | 211500 | 300MG/16.7ML (18MG/ML) | SOLUTION;INTRAVENOUS |
Mylan Labs Ltd | nevirapine | 205921 | 400MG | TABLET, EXTENDED RELEASE;ORAL |
Mylan Labs Ltd | bendamustine hydrochloride | 204104 | 100MG/VIAL | POWDER;IV (INFUSION) |
Mylan Labs Ltd | bivalirudin | 091468 | 250MG/VIAL | INJECTABLE;INJECTION |
Mylan Labs Ltd | abacavir;lamivudine | 204915 | 120MG;60MG | TABLET;ORAL |
Mylan Labs Ltd | pemetrexed | 203628 | 500MG | INJECTABLE;INJECTION |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |