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 |
---|---|---|---|---|
Matrix Labs Ltd | efavirenz | 022461 | 50MG | TABLET; ORAL |
Micro Labs Ltd | efavirenz | 202042 | 200MG | CAPSULE; ORAL |
Mylan | efavirenz, emtricitabine and tenofovir alafenamide | 213509 | 400MG; 200MG; 25MG | TABLET; ORAL |
Emcure Pharma | efavirenz | 078958 | 600MG | TABLET; ORAL |
Cipla Limited | efavirenz | 077916 | 600MG | TABLET; ORAL |
Matrix Labs Ltd | efavirenz; emtricitabine; tenofovir disoproxil fumarate | 090437 | 600MG; 200MG; 300MG | TABLET; ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |