Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012142
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYTOXAN CYCLOPHOSPHAMIDE 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
CYTOXAN CYCLOPHOSPHAMIDE 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
CYTOXAN (LYOPHILIZED) CYCLOPHOSPHAMIDE 500MG/VIAL INJECTABLE;INJECTION Discontinued None Yes No
CYTOXAN (LYOPHILIZED) CYCLOPHOSPHAMIDE 1GM/VIAL INJECTABLE;INJECTION Discontinued None Yes No
CYTOXAN (LYOPHILIZED) CYCLOPHOSPHAMIDE 2GM/VIAL INJECTABLE;INJECTION Discontinued None Yes No
CYTOXAN (LYOPHILIZED) CYCLOPHOSPHAMIDE 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
CYTOXAN (LYOPHILIZED) CYCLOPHOSPHAMIDE 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
CYTOXAN (LYOPHILIZED) CYCLOPHOSPHAMIDE 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
LYOPHILIZED CYTOXAN CYCLOPHOSPHAMIDE 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
LYOPHILIZED CYTOXAN CYCLOPHOSPHAMIDE 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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 2 - New Active Ingredient 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
10/31/2016 SUPPL-115 Manufacturing (CMC)

Label is not available on this site.

07/22/2014 SUPPL-114 Manufacturing (CMC)

Label is not available on this site.

05/07/2013 SUPPL-112 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-109 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012142s109lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/012142s109ltr.pdf
11/07/2003 SUPPL-107 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12142scf107ltr.pdf
11/02/2000 SUPPL-104 Manufacturing (CMC)

Label is not available on this site.

01/30/2001 SUPPL-103 Labeling

Label is not available on this site.

05/28/1999 SUPPL-102 Labeling

Label is not available on this site.

06/15/2000 SUPPL-101 Labeling

Label is not available on this site.

12/20/1995 SUPPL-98 Labeling

Label is not available on this site.

10/22/1990 SUPPL-93 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1989 SUPPL-92 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1988 SUPPL-91 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1988 SUPPL-90 Labeling

Label is not available on this site.

11/20/1987 SUPPL-89 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1987 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

12/08/1986 SUPPL-87 Labeling

Label is not available on this site.

12/08/1986 SUPPL-86 Labeling

Label is not available on this site.

05/30/1986 SUPPL-85 Labeling

Label is not available on this site.

05/30/1986 SUPPL-84 Labeling

Label is not available on this site.

07/11/1986 SUPPL-83 Labeling

Label is not available on this site.

07/11/1986 SUPPL-82 Labeling

Label is not available on this site.

07/11/1986 SUPPL-81 Labeling

Label is not available on this site.

05/30/1986 SUPPL-80 Labeling

Label is not available on this site.

04/28/1988 SUPPL-79 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1986 SUPPL-77 Labeling

Label is not available on this site.

08/30/1985 SUPPL-76 Labeling

Label is not available on this site.

08/30/1985 SUPPL-75 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/1985 SUPPL-74 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/18/1985 SUPPL-73 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1985 SUPPL-72 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/10/1984 SUPPL-71 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/10/1985 SUPPL-70 Labeling

Label is not available on this site.

09/24/1985 SUPPL-69 Labeling

Label is not available on this site.

12/05/1985 SUPPL-68 Labeling

Label is not available on this site.

07/18/1984 SUPPL-67 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/15/1984 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

08/20/1984 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

05/24/1984 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1984 SUPPL-63 Labeling

Label is not available on this site.

10/17/1984 SUPPL-61 Labeling

Label is not available on this site.

04/05/1984 SUPPL-59 Labeling

Label is not available on this site.

01/04/1984 SUPPL-58 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/06/1985 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

03/15/1983 SUPPL-56 Labeling

Label is not available on this site.

06/14/1984 SUPPL-55 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/30/1982 SUPPL-54 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/29/1987 SUPPL-53 Labeling

Label is not available on this site.

07/28/1982 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/1981 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/1981 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/1981 SUPPL-47 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/21/1981 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/27/1980 SUPPL-45 Labeling

Label is not available on this site.

08/03/1979 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

06/19/1979 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/16/1979 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1978 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

12/03/1979 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1978 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1977 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1977 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/1977 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

11/01/1976 SUPPL-30 Labeling

Label is not available on this site.

06/10/1976 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

04/29/1987 SUPPL-28 Efficacy-New Indication

Label is not available on this site.

01/13/1976 SUPPL-25 Manufacturing (CMC)-Control

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-112 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012141s090,012142s112lbl.pdf
03/31/2012 SUPPL-109 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012142s109lbl.pdf

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