Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 217651
Company: BAXTER HLTHCARE CORP
Company: BAXTER HLTHCARE CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 500MG/2.5ML (200MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 1GM/5ML (200MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/27/2023 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217651Orig1s000Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217651Orig1s000Correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217651Orig1s000TOC.html |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/27/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217651Orig1s000Correctedlbl.pdf |