Generic Companies with Tentative Approvals for: Par Pharm
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Par Pharm 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 |
---|---|---|---|---|
Par Pharm Inc | fingolimod | 207965 | 0.5MG | CAPSULE;ORAL |
Par Pharm Inc | lurasidone hydrochloride | 207948 | 40MG | TABLET;ORAL |
Par Pharm Inc | milnacipran hydrochloride | 205062 | 25MG | TABLET;ORAL |
Par Pharm | sumatriptan; naproxen sodium | 090753 | 85MG; 500MG | TABLET; ORAL |
Par Pharm | fluvastatin sodium | 078872 | 80MG | TABLET, EXTENDED RELEASE; ORAL |
Par Pharm Inc | dextromethorphan hydrobromide;quinidine sulfate | 202993 | 20MG;10MG | CAPSULE;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |