Generic Companies with Tentative Approvals for: Amneal
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Amneal 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 Llc | spironolactone | 215572 | 25MG/5ML | SUSPENSION;ORAL |
Amneal Pharms | saxagliptin;metformin hydrochloride | 205942 | 5MG;500MG | TABLET, EXTENDED RELEASE;ORAL |
Amneal Pharms | donepezil hydrochloride; memantine hydrochloride | 208328 | 10MG;14MG | CAPSULE, EXTENDED RELEASE;ORAL |
Amneal Pharms | saxagliptin | 205941 | 2.5MG | TABLET;ORAL |
Amneal Eu Ltd | vasopressin | 212945 | 200UNITS/10ML(20UNITS/ML) | INJECTABLE;INJECTION |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |