Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020524
Company: MYLAN

Products on NDA 020524

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MENTAX	BUTENAFINE HYDROCHLORIDE	1%	CREAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020524

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/18/1996	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/pre96/020524Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/17/2002	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/06/2001	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20524s5lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20524S5ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-524S005_Mentax.cfm
11/01/1999	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/31/1997	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
03/11/1997	SUPPL-2	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
11/25/1997	SUPPL-1	Efficacy-New Dosing Regimen		Label is not available on this site.

Labels for NDA 020524

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/06/2001	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20524s5lbl.pdf