Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 220712
Company: AMNEAL PHARMS NY
Company: AMNEAL PHARMS NY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KITPROZY | CARFILZOMIB | 60MG/ML, 2/ML | VIAL; SINGLE-USE | Prescription | None | No | No |
| KITPROZY | CARFILZOMIB | 120MG/2ML (60MG/ML), 2ML | VIAL; SINGLE-USE | 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 |
|---|---|---|---|---|---|---|---|
| 03/19/2026 | ORIG-1 | Tentative Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220712Orig1s000TAltr.pdf |