Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020400
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AVITA TRETINOIN 0.025% GEL;TOPICAL Prescription BT No No
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.

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

AVITA

There are no Therapeutic Equivalents.

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