Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211552
Company: ZYDUS LIFESCIENCES

Products on ANDA 211552

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	25MG	CAPSULE;ORAL	Prescription	AB	No	No
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	50MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211552

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/13/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211552

CYCLOPHOSPHAMIDE

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	25MG	CAPSULE;ORAL	Prescription	No	AB	215892	ALEMBIC
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	25MG	CAPSULE;ORAL	Prescription	No	AB	209872	ANIMA
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	25MG	CAPSULE;ORAL	Prescription	No	AB	211608	CIPLA
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	25MG	CAPSULE;ORAL	Prescription	Yes	AB	203856	HIKMA
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	25MG	CAPSULE;ORAL	Prescription	No	AB	211552	ZYDUS LIFESCIENCES

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	50MG	CAPSULE;ORAL	Prescription	No	AB	215892	ALEMBIC
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	50MG	CAPSULE;ORAL	Prescription	No	AB	209872	ANIMA
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	50MG	CAPSULE;ORAL	Prescription	No	AB	211608	CIPLA
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	50MG	CAPSULE;ORAL	Prescription	Yes	AB	203856	HIKMA
CYCLOPHOSPHAMIDE	CYCLOPHOSPHAMIDE	50MG	CAPSULE;ORAL	Prescription	No	AB	211552	ZYDUS LIFESCIENCES