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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203856
Company: HIKMA

Summary Review

Products on NDA 203856

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203856

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/16/2013	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203856s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203856Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203856Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203856Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/26/2019	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203856s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203856Orig1s003ltr.pdf

Labels for NDA 203856

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/26/2019	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203856s003lbl.pdf
09/16/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203856s000lbl.pdf

Therapeutic Equivalents for NDA 203856

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

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