Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210046
Company: AMNEAL

Products on ANDA 210046

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210046

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210046

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