Generic Companies with Tentative Approvals for: efavirenz
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efavirenz 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 |
|---|---|---|---|---|
| Par Formulations Private Ltd | efavirenz | 202990 | 600MG | TABLET; ORAL |
| Teva Pharms Usa | efavirenz | 091175 | 600MG | TABLET;ORAL |
| Mylan | efavirenz, emtricitabine and tenofovir alafenamide | 213509 | 400MG; 200MG; 25MG | TABLET; ORAL |
| Micro Labs Ltd India | efavirenz | 205389 | 100MG | TABLET;ORAL |
| Cipla Limited | efavirenz | 077916 | 600MG | TABLET; ORAL |
| Cipla Limited | efavirenz; emtricitabine; tenofovir disoproxil fumarate | 091593 | 300MG | TABLET; ORAL |
| >Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |
