Generic Companies with Tentative Approvals for: paliperidone palmitate
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paliperidone palmitate 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 |
---|---|---|---|---|
Mylan Pharmaceuticals Inc A Viatris Co | paliperidone palmitate | 215682 | 410MG/1.315ML | INJECTION;SUSPENSION |
Mylan Pharmaceuticals Inc A Viatris Co | paliperidone palmitate | 215682 | 1560MG/5.0ML | INJECTION;SUSPENSION |
Mylan Pharms Inc | paliperidone palmitate | 216228 | 273MG/0.88ML | SUSPENSION, EXTENDED RELEASE;INJECTABLE |
Pharmascience Inc | paliperidone palmitate | 210397 | SUSPENSION;EXTENDED RELEASE | |
Mylan Pharmaceuticals Inc A Viatris Co | paliperidone palmitate | 215682 | 819MG/2.625ML | INJECTION;SUSPENSION |
Tolmar | paliperidone palmitate | 211995 | 78MG/0.5ML | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |