Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020400
Company: MYLAN

Products on NDA 020400

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AVITA	TRETINOIN	0.025%	GEL;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020400

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/1998	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20400_appltrs.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20400.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/17/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
08/10/2011	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020400s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020400s005ltr.pdf
12/06/2001	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/15/1999	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 020400

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/10/2011	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020400s005lbl.pdf