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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018738
Company: JOURNEY

Products on NDA 018738

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018738

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/1985	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018738Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2014	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
07/08/2009	SUPPL-9	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018738s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018738s009ltr.pdf
10/19/2001	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/30/2003	SUPPL-7	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/2003/18738slr007ltr.pdf
09/22/1993	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
03/08/1991	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
02/14/1991	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/20/1990	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
08/20/1990	SUPPL-2	Labeling		Label is not available on this site.
12/18/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

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

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