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 | empagliflozin;metformin hydrochloride | 212373 | 5MG;1000MG | TABLET;ORAL |
| Macleods Pharms Ltd | sitagliptin phosphate | 211073 | 25MG | TABLET; ORAL |
| Macleods Pharms Ltd | dolutegravir sodium | 214397 | EQ 10MG BASE | TABLET;ORAL |
| Macleods Pharms Ltd | milnacipran hydrochloride | 210944 | 25MG | TABLET;ORAL |
| Macleods Pharms Ltd | hydrochlorothiazide; irbesartan | 202414 | 12.5MG;150MG | TABLET;ORAL |
| Macleods Pharms Ltd | metformin hydrochloride || sitagliptin | 212338 | 1000MG | TABLET;FILM COATED |
| >Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |
