Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021727
Company: ULURU
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-Container/Carton Labels, Labeling-Package Insert |
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 |