Generic Companies with Tentative Approvals for: Macleods Pharms Ltd
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Macleods Pharms 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 |
---|---|---|---|---|
Macleods Pharms Ltd | dolutegravir;lamivudine;tenofovir disoproxil fumarate | 210796 | 50MG/300MG/300MG | TABLET;ORAL |
Macleods Pharms Ltd | memantine hydrochloride | 206310 | 14MG | CAPSULE, EXTENDED RELEASE;ORAL |
Macleods Pharms Ltd | pregabalin | 205924 | 100MG | CAPSULE;ORAL |
Macleods Pharms Ltd | lamivudine; nevirapine; zidovudine | 202589 | 150MG; 200MG; 300MG | TABLET; ORAL |
Macleods Pharms Ltd | irbesartan: hydrochlorothiazide | 202414 | 300MG; 25MG | TABLET; ORAL |
Macleods Pharms Ltd | dolutegravir sodium | 214397 | EQ 25MG BASE | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |