Generic Companies with Tentative Approvals for: Par Pharm Inc
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Par Pharm Inc 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 | lurasidone hydrochloride | 207948 | 120MG | TABLET;ORAL |
Par Pharm Inc | lurasidone hydrochloride | 207948 | 40MG | TABLET;ORAL |
Par Pharm Inc | citric acid; magnesium oxide; sodium picosulfate | 205743 | 12GM/PACKET;3.5GM/PACKET;10MG/PACKET | FOR SOLUTION;ORAL |
Par Pharm Inc | cyclobenzaprine hydrochloride | 090864 | 15MG | CAPSULE, EXTENDED RELEASE; ORAL |
Par Pharm Inc | fingolimod | 207965 | 0.5MG | CAPSULE;ORAL |
Par Pharm Inc | milnacipran hydrochloride | 205062 | 100MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |