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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020428
Company: ALMIRALL

Products on NDA 020428

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020428

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/1995	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/pre96/020428Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/20/2024	SUPPL-27		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020428Orig1s027lbl.pdf
01/06/2020	SUPPL-22	Labeling-Package Insert, Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020428Orig1s022ltr.pdf
06/10/2003	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20428slr016_azelex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20428slr016ltr.pdf
02/19/2002	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/27/2001	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20428s13lbl.pdf
04/05/2000	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
11/10/1999	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
11/10/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/04/1998	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
09/23/1997	SUPPL-7	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/20428S1S7_Azelex.pdf
09/04/1998	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
06/29/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/27/1996	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
05/17/1996	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
05/17/1996	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
05/17/1996	SUPPL-1	Manufacturing (CMC)-Control	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/20428S1S7_Azelex.pdf

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

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