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 | ivacaftor | 217431 | 50MG | GRANULE;ORAL |
Lupin Ltd | diclofenac | 207393 | 35MG | CAPSULE;ORAL |
Lupin Ltd | milnacipran hydrochloride | 205286 | 25MG | TABLET;ORAL |
Lupin Ltd | hydrochlorothiazide; irbesartan | 201524 | 12.5MG;150MG | TABLET;ORAL |
Lupin Ltd | doxycycline | 091277 | 40MG | CAPSULE; ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |