Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020511
Company: ULURU
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APHTHASOL AMLEXANOX 5% PASTE;DENTAL 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
12/17/1996 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020511ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/07/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/2002 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20511s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20511s002ltr.pdf
11/10/1998 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/11/2002 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20511s002lbl.pdf

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