Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 219271
Company: HETERO LABS LIMITED
Company: HETERO LABS LIMITED
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 1000MG/5ML | INJECTION;SOLUTION | None (Tentative Approval) | None | No | No |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 500MG/2.5ML | INJECTION;SOLUTION | None (Tentative Approval) | None | No | No |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 2000MG/10ML | INJECTION;SOLUTION | None (Tentative Approval) | 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 |
|---|---|---|---|---|---|---|---|
| 04/29/2026 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219271Orig1s000TAltr.pdf |