FDA Approval for TALZENNA issued to PFIZER INC
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 217439
Company: PFIZER INC
Company: PFIZER INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TALZENNA | TALAZOPARIB | 0.1MG | CAPSULE; ORAL | Prescription | None | No | No |
| TALZENNA | TALAZOPARIB | 0.25MG | CAPSULE; ORAL | Prescription | None | No | No |
| TALZENNA | TALAZOPARIB | 0.35MG | CAPSULE; ORAL | Prescription | None | No | No |
| TALZENNA | TALAZOPARIB | 0.5MG | CAPSULE; ORAL | Prescription | None | No | No |
| TALZENNA | TALAZOPARIB | 0.75MG | CAPSULE; ORAL | Prescription | None | No | No |
| TALZENNA | TALAZOPARIB | 1MG | CAPSULE; ORAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/07/2024 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217439Orig1s000ltr.pdf |