An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 211608
Company: CIPLA

Products on ANDA 211608

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 211608

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/03/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211608

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

Top