Application 012142

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYTOXAN	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	CYTOXAN	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	200MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	CYTOXAN (LYOPHILIZED)	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	500MG/VIAL	Yes	No
004	CYTOXAN (LYOPHILIZED)	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	1GM/VIAL	Yes	No
005	CYTOXAN (LYOPHILIZED)	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	2GM/VIAL	Yes	No
006	LYOPHILIZED CYTOXAN	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	100MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
007	LYOPHILIZED CYTOXAN	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	200MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
008	CYTOXAN (LYOPHILIZED)	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
009	CYTOXAN (LYOPHILIZED)	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
010	CYTOXAN (LYOPHILIZED)	CYCLOPHOSPHAMIDE	INJECTABLE;INJECTION	1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10019-988	CYCLOPHOSPHAMIDE	Cyclophosphamide	Baxter Healthcare Corporation	NDA	Current
10019-988	CYCLOPHOSPHAMIDE	Cyclophosphamide	Baxter Healthcare Corpora	NDA	Current
10019-989	CYCLOPHOSPHAMIDE	Cyclophosphamide	Baxter Healthcare Corporation	NDA	Current
10019-989	CYCLOPHOSPHAMIDE	Cyclophosphamide	Baxter Healthcare Corpora	NDA	Current
10019-990	CYCLOPHOSPHAMIDE	Cyclophosphamide	Baxter Healthcare Corporation	NDA	Current
10019-990	CYCLOPHOSPHAMIDE	Cyclophosphamide	Baxter Healthcare Corpora	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79553	SUPPL	2024-09-06
79549	SUPPL	2024-09-06
307	SUPPL	2013-05-10
10794	SUPPL	2013-05-09
306	SUPPL	2012-04-04
33075	SUPPL	2012-04-02
11990	SUPPL	2003-11-25