Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020428
Company: ALMIRALL

Products on NDA 20428

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZELEX	AZELAIC ACID	20%	CREAM;TOPICAL	Prescription	None	Yes	Yes

Labels for NDA 020428

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/20/2024	SUPPL-27	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020428Orig1s027lbl.pdf
06/10/2003	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20428slr016_azelex_lbl.pdf
04/27/2001	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20428s13lbl.pdf