Generic Companies with Tentative Approvals for: Mylan Labs Ltd
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Mylan Labs Ltd 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 | abacavir;lamivudine | 204915 | 120MG;60MG | TABLET; ORAL SUSPENSION |
| Mylan Labs Ltd | emtricitabine, tenofovir alafenamide | 211148 | 200MG | TABLET; ORAL |
| Mylan Labs Ltd | emtricitabine, tenofovir alafenamide | 211148 | 10MG | TABLET; ORAL |
| Mylan Labs Ltd | atazanavir sulfate;ritonavir;lamivudine;zidovudine | 206041 | 300MG;100MG;150MG;300MG | TABLET;ORAL |
| Mylan Labs Ltd | dolutegravir sodium | 209602 | 50MG | TABLET;ORAL |
| Mylan Labs Ltd | bivalirudin | 091468 | 250MG/VIAL | INJECTABLE;INJECTION |
| Mylan Labs Ltd | emtricitabine, tenofovir alafenamide | 211148 | 120MG | TABLET; ORAL |
| >Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |
