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 | memantine hydrochloride | 206310 | 28MG | CAPSULE, EXTENDED RELEASE;ORAL |
Macleods Pharms Ltd | dolutegravir sodium | 214397 | EQ 50MG BASE | TABLET;ORAL |
Macleods Pharms Ltd | efavirenz;lamivudine;tenofovir disoproxil fumarate | 205861 | 600MG;300MG;300MG | TABLET;ORAL |
Macleods Pharms Ltd | memantine hydrochloride | 206310 | 21MG | CAPSULE, EXTENDED RELEASE;ORAL |
Macleods Pharms Ltd | lamivudine; tenofovir disoproxil fumarate | 203283 | 300MG; 300MG | TABLET; ORAL |
Macleods Pharms Ltd | milnacipran hydrochloride | 210944 | 100MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |