Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020126
Company: MYLAN

Products on NDA 20126

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZONALON	DOXEPIN HYDROCHLORIDE	5%	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Labels for NDA 020126

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2002	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20126slr006_Zonalon_lbl.pdf