Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040032
Company: ROXANE
Company: ROXANE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 50MG | TABLET;ORAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 08/17/1999 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/040032_cyclophosphamide_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/21/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/10/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/17/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/17/2002 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/17/2002 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/16/2000 | SUPPL-1 | Labeling |
Label is not available on this site. |