Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202513
Company: ALLERGAN
Company: ALLERGAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GELNIQUE 3% | OXYBUTYNIN | 3% | GEL, METERED;TRANSDERMAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
12/07/2011 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202513s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202513s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202513_anturol_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202513Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/10/2015 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202513s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202513Orig1s005ltr.pdf | |
01/09/2013 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202513s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202513Orig1s003ltr_replacement.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/10/2015 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202513s005lbl.pdf | |
01/09/2013 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202513s003lbl.pdf | |
12/07/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202513s000lbl.pdf |