Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022204
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GELNIQUE | OXYBUTYNIN CHLORIDE | 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL;TRANSDERMAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
01/27/2009 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022204lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022204s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022204s000_gelnique_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022204s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/25/2017 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022204s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022204Orig1s010ltr.pdf | |
07/10/2015 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022204s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022204Orig1s009ltr.pdf | |
08/04/2015 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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08/12/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/10/2012 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022204s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022204Orig1s006ltr.pdf | |
01/31/2011 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022204s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022204s004ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/25/2017 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022204s010lbl.pdf | |
07/10/2015 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022204s009lbl.pdf | |
10/10/2012 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022204s006lbl.pdf | |
01/31/2011 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022204s004lbl.pdf | |
01/27/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022204lbl.pdf |