Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012141
Company: BAXTER HLTHCARE

Products on NDA 12141

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYTOXAN	CYCLOPHOSPHAMIDE	50MG	TABLET;ORAL	Prescription	None	Yes	Yes
CYTOXAN	CYCLOPHOSPHAMIDE	25MG	TABLET;ORAL	Prescription	None	Yes	No

Labels for NDA 012141

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/07/2013	SUPPL-90	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012141s090,012142s112lbl.pdf
03/31/2012	SUPPL-89	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012141s089lbl.pdf