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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018737
Company: JOURNEY

Products on NDA 018737

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018737

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/1989	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/26/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/19/2001	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/30/2003	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18737slr003_exelderm_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18737slr003ltr.pdf
05/13/1991	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 018737

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/30/2003	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18737slr003_exelderm_lbl.pdf

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