Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012141
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYTOXAN CYCLOPHOSPHAMIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
CYTOXAN CYCLOPHOSPHAMIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
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

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