Generic Companies with Tentative Approvals for: dolutegravir sodium
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dolutegravir sodium 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 |
---|---|---|---|---|
Micro Labs Ltd | dolutegravir sodium | 212179 | 50MG | TABLET;ORAL |
Mylan Labs Ltd | dolutegravir sodium | 209602 | 50MG | TABLET;ORAL |
Cipla Ltd | dolutegravir sodium | 210812 | 50MG | TABLET;ORAL |
Macleods Pharms Ltd | dolutegravir sodium | 214566 | 10MG | TABLET; ORAL SUSPENSION |
Macleods Pharms Ltd | dolutegravir sodium | 214397 | EQ 25MG BASE | TABLET;ORAL |
Macleods Pharms Ltd | dolutegravir sodium | 214397 | EQ 50MG BASE | TABLET;ORAL |
Aurobindo Pharma Ltd | dolutegravir sodium | 208355 | 50MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |