Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021727
Company: ULURU
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMLEXANOX AMLEXANOX 2MG PATCH;TOPICAL Discontinued None 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
09/29/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21727lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21727ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021727s000_OraDiscTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/06/2008 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/29/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21727lbl.pdf

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