Generic Companies with Tentative Approvals for: Macleods Pharma
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Macleods Pharma 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 Pharmaceuticals Ltd | dapagliflozin, metformin hydrochloride | 211559 | 2.5MG | TABLET, EXTENDED RELEASE |
| Macleods Pharmaceuticals Ltd | abacavir, dolutegravir, lamivudine | 217830 | 30MG | TABLET |
| Macleods Pharmaceuticals Ltd | vortioxetine | 211165 | 20MG | TABLET:FILM COATED |
| Macleods Pharmaceuticals Ltd | dapagliflozin, metformin hydrochloride | 211559 | 500MG | TABLET, EXTENDED RELEASE |
| Macleods Pharmaceuticals Ltd | metformin hydrochloride; canagliflozin | 215255 | 150MG | TABLET, EXTENDED RELEASE |
| Macleods Pharma | lamivudine; stavudine | 022541 | 150MG; 30MG | TABLET; ORAL |
| >Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |
