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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020694
Company: JANSSEN PHARMA

Products on NDA 020694

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPORANOX	ITRACONAZOLE	100MG	CAPSULE; ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020694

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/06/1996	ORIG-1	Approval	Type 6 - New Indication (no longer used)	STANDARD; Orphan	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020694ap.pdf

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