Generic Companies with Tentative Approvals for: Lupin Ltd
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Lupin 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 |
---|---|---|---|---|
Lupin Ltd | pregabalin | 201989 | 20MG/ML | SOLUTION; ORAL |
Lupin Ltd | norethindrone acetate;ethinyl estradiol;ferrous fumarate | 203113 | 1MG;0.01MG;75MG | TABLET;ORAL |
Lupin Ltd | empagliflozin;metformin hydrochloride | 213654 | 12.5MG; 1GM | TABLET, EXTENDED RELEASE;ORAL |
Lupin Ltd | fesoterodine fumarate | 204893 | 4MG | TABLET, EXTENDED RELEASE;ORAL |
Lupin Ltd | balsalazide disodium | 206529 | 1.1GM | TABLET;ORAL |
Lupin Ltd | diclofenac | 207393 | 18MG | CAPSULE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |