Cytoxan

NDA 12141, held by Baxter Hlthcare. Cyclophosphamide.

As of Nov 14, 2026, NDA 12141 (Cytoxan), held by Baxter Hlthcare, was first approved by FDA on Nov 16, 1959, with 47 approved supplements and 0 published complete response letters.

First approved: Nov 16, 1959
Review: Priority
Supplements approved: 47
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Cyclophosphamide Tablets is an alkylating drug indicated for treatment of:

Malignant Diseases: malignant lymphomas: Hodgkin’s disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt’s lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma
Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been establishe…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 48 submissions below


Apr 29, 1987	Supplement 37Efficacy (new indication or use)	Approved	None posted
Nov 16, 1959	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Cytoxan50MG · tablet;oral	Cyclophosphamide	RxReference drug
Cytoxan25MG · tablet;oral	Cyclophosphamide	RxReference drug

All 48 submissions, including labeling and manufacturing supplements


Aug 7, 2020	Supplement 91Manufacturing	Approved	Letter
May 7, 2013	Supplement 90Labeling · Standard review	Approved	Letter Label
Mar 31, 2012	Supplement 89Labeling · Standard review	Approved	Letter Label
Feb 27, 2003	Supplement 87Labeling · Standard review	Approved	Letter
Jan 30, 2001	Supplement 86Labeling · Standard review	Approved	None posted
Jun 15, 2000	Supplement 83Labeling · Standard review	Approved	None posted
Aug 20, 1999	Supplement 85Manufacturing · Priority review	Approved	None posted
May 28, 1999	Supplement 84Labeling · Standard review	Approved	None posted
Dec 20, 1995	Supplement 81Labeling · Standard review	Approved	None posted
Apr 29, 1987	Supplement 77Manufacturing · Priority review	Approved	None posted
Apr 29, 1987	Supplement 63Labeling	Approved	None posted
Apr 29, 1987	Supplement 37Efficacy (new indication or use)	Approved	None posted
Jul 11, 1986	Supplement 75Labeling	Approved	None posted
Jul 11, 1986	Supplement 74Labeling	Approved	None posted
Jul 11, 1986	Supplement 73Labeling	Approved	None posted
Jul 11, 1986	Supplement 72Labeling	Approved	None posted
Jan 15, 1986	Supplement 71Labeling	Approved	None posted
Dec 5, 1985	Supplement 67Manufacturing · Priority review	Approved	None posted
Dec 4, 1985	Supplement 70Labeling	Approved	None posted
Aug 30, 1985	Supplement 69Manufacturing · Priority review	Approved	None posted
Aug 10, 1984	Supplement 66Manufacturing · Priority review	Approved	None posted
Mar 15, 1983	Supplement 65Labeling	Approved	None posted
Jul 28, 1982	Supplement 62Manufacturing · Priority review	Approved	None posted
Mar 4, 1982	Supplement 64Manufacturing · Priority review	Approved	None posted
Feb 27, 1981	Supplement 60Manufacturing · Priority review	Approved	None posted
Sep 27, 1980	Supplement 61Labeling	Approved	None posted
Jan 25, 1980	Supplement 57Manufacturing · Priority review	Approved	None posted
Aug 3, 1979	Supplement 59Manufacturing · Priority review	Approved	None posted
May 24, 1979	Supplement 58Manufacturing · Priority review	Approved	None posted
Apr 30, 1979	Supplement 56Manufacturing · Priority review	Approved	None posted
Nov 27, 1978	Supplement 53Manufacturing · Priority review	Approved	None posted
Aug 28, 1978	Supplement 55Manufacturing · Priority review	Approved	None posted
Aug 16, 1978	Supplement 54	Approved	None posted
Aug 8, 1978	Supplement 47Manufacturing · Priority review	Approved	None posted
Jul 19, 1978	Supplement 52Manufacturing · Priority review	Approved	None posted
May 23, 1978	Supplement 51Manufacturing · Priority review	Approved	None posted
Nov 16, 1977	Supplement 49Labeling	Approved	None posted
Nov 16, 1977	Supplement 50Manufacturing · Priority review	Approved	None posted
May 16, 1977	Supplement 46Manufacturing · Priority review	Approved	None posted
Apr 25, 1977	Supplement 48Manufacturing · Priority review	Approved	None posted
Mar 17, 1977	Supplement 39Manufacturing · Priority review	Approved	None posted
Mar 17, 1977	Supplement 45Manufacturing · Priority review	Approved	None posted
Nov 1, 1976	Supplement 42Labeling	Approved	None posted
Oct 18, 1976	Supplement 35REMS · Priority review	Approved	None posted
Oct 18, 1976	Supplement 44Manufacturing · Priority review	Approved	None posted
Jun 9, 1976	Supplement 40Manufacturing · Priority review	Approved	None posted
Jun 9, 1976	Supplement 41Manufacturing · Priority review	Approved	None posted
Nov 16, 1959	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 12141
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters