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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040745
Company: BAXTER HLTHCARE

Products on ANDA 040745

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040745

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/21/2008	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/040745Orig1s000ChemR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2025	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/29/2024	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
10/25/2014	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040745Orig1s003lbl.pdf
06/17/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 040745

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2014	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040745Orig1s003lbl.pdf

Therapeutic Equivalents for ANDA 040745

CYCLOPHOSPHAMIDE

INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	210046	AMNEAL
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040745	BAXTER HLTHCARE
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	218644	EPIC PHARMA LLC
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204555	HENGRUI PHARMA
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	216958	HIKMA
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	214529	SAGENT PHARMS INC
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215089	SUNNY
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	500MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	211757	XGEN PHARMS

INJECTABLE;INJECTION; 1GM/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	210046	AMNEAL
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040745	BAXTER HLTHCARE
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	218644	EPIC PHARMA LLC
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204555	HENGRUI PHARMA
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	216958	HIKMA
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	214529	SAGENT PHARMS INC
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215089	SUNNY
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	1GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	211757	XGEN PHARMS

INJECTABLE;INJECTION; 2GM/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	210046	AMNEAL
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040745	BAXTER HLTHCARE
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	218644	EPIC PHARMA LLC
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204555	HENGRUI PHARMA
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	216958	HIKMA
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	214529	SAGENT PHARMS INC
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	215089	SUNNY
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	2GM/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	211757	XGEN PHARMS

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