Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018738
Company: JOURNEY

Products on NDA 18738

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EXELDERM	SULCONAZOLE NITRATE	1%	SOLUTION;TOPICAL	Prescription	None	Yes	Yes

Labels for NDA 018738

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/08/2009	SUPPL-9	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018738s009lbl.pdf
05/30/2003	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18737slr003_exelderm_lbl.pdf