Generic Companies with Tentative Approvals for: Lupin
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Lupin 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 | minocycline hydrochloride | 091424 | EQ 90MG BASE | TABLET, EXTENDED RELEASE;ORAL |
Lupin Ltd | irbesartan; hydrochlorothiazide | 201524 | 300MG; 25MG | TABLET; ORAL |
Lupin Ltd | norethindrone acetate;ethinyl estradiol;ferrous fumarate | 203113 | 1MG;0.01MG;75MG | TABLET;ORAL |
Lupin | dasatinib | 214350 | 140MG | TABLET;ORAL |
Lupin Ltd | armodafinil | 200751 | 150MG | TABLET;ORAL |
Lupin | dasatinib | 214350 | 50MG | TABLET;ORAL |
Lupin Ltd | balsalazide disodium | 206529 | 1.1GM | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |