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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020637
Company: AZURITY

Products on NDA 20637

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLIADEL	CARMUSTINE	7.7MG	IMPLANT;INTRACRANIAL	Prescription	None	Yes	Yes

Labels for NDA 020637

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
12/05/2018	SUPPL-29	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020637s029lbl.pdf
08/16/2013	SUPPL-26	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020637s026lbl.pdf
02/25/2003	SUPPL-16	Efficacy-New Indication	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020637s016lbl.pdf

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