Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020784
Company: SANOFI AVENTIS US

Products on NDA 020784

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NASACORT HFA	TRIAMCINOLONE ACETONIDE	0.055MG/SPRAY	SPRAY, METERED;NASAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020784

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/07/2004	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20784ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020784s000TOC.html