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Generic Companies with Tentative Approvals for: Amneal Pharms
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Amneal Pharms 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 |
---|---|---|---|---|
Amneal Pharms | donepezil hydrochloride; memantine hydrochloride | 208328 | 10MG;14MG | CAPSULE, EXTENDED RELEASE;ORAL |
Amneal Pharms | diclofenac sodium | 208198 | 2% | SOLUTION;TOPICAL |
Amneal Pharms | dronedarone | 206649 | 400MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |