Generic Companies with Tentative Approvals for: Cipla Ltd
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Cipla 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 |
|---|---|---|---|---|
| Cipla Ltd | dolutegravir sodium | 209658 | 50MG | TABLET;ORAL |
| Cipla Ltd | dolutegravir sodium | 210812 | 50MG | TABLET;ORAL |
| Cipla Ltd | darunavir | 207189 | 600MG | TABLET;ORAL |
| Cipla Ltd | darunavir | 207189 | 400MG | TABLET;ORAL |
| Cipla Ltd | vortioxetine | 211085 | 5MG | TABLET;ORAL |
| Cipla Ltd | darunavir | 207189 | 150MG | TABLET;ORAL |
| Cipla Ltd | lamivudine; nevirapine; zidovudine | 203076 | 30MG; 50MG; 60MG | TABLET; ORAL SUSPENSION |
| >Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |
