Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYTOXAN | CYCLOPHOSPHAMIDE | 50MG | TABLET;ORAL | Prescription | None | Yes | Yes |
| CYTOXAN | CYCLOPHOSPHAMIDE | 25MG | TABLET;ORAL | Prescription | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 11/16/1959 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/07/2020 | SUPPL-91 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/012141Orig1s091ltr.pdf |
| 05/07/2013 | SUPPL-90 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012141s090,012142s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012141Orig1s090,012142Orig1s112ltr.pdf | |
| 03/31/2012 | SUPPL-89 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012141s089lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/012141s089ltr.pdf | |
| 02/27/2003 | SUPPL-87 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12141slr087ltr.pdf |
| 01/30/2001 | SUPPL-86 | Labeling |
Label is not available on this site. |
||
| 08/20/1999 | SUPPL-85 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1999 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 06/15/2000 | SUPPL-83 | Labeling |
Label is not available on this site. |
||
| 12/20/1995 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 04/29/1987 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1986 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 07/11/1986 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 07/11/1986 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
| 07/11/1986 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 01/15/1986 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
| 12/04/1985 | SUPPL-70 | Labeling |
Label is not available on this site. |
||
| 08/30/1985 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1985 | SUPPL-67 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/10/1984 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/1983 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 03/04/1982 | SUPPL-64 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/29/1987 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 07/28/1982 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/27/1980 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 02/27/1981 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1979 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/1979 | SUPPL-58 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/25/1980 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1979 | SUPPL-56 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1978 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/16/1978 | SUPPL-54 |
Label is not available on this site. |
|||
| 11/27/1978 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/19/1978 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/1978 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/16/1977 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1977 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 04/25/1977 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/1978 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1977 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1977 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/1976 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1976 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 06/09/1976 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/09/1976 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/17/1977 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1987 | SUPPL-37 | Efficacy-New Indication |
Label is not available on this site. |
||
| 10/18/1976 | SUPPL-35 | Unspecified |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/07/2013 | SUPPL-90 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012141s090,012142s112lbl.pdf | |
| 03/31/2012 | SUPPL-89 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012141s089lbl.pdf |