Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202211
Company: ABBVIE
Company: ABBVIE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYTROL FOR WOMEN | OXYBUTYNIN | 3.9MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/25/2013 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202211Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202211Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202211_oxytrol_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202211Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/03/2016 | SUPPL-4 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202211Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202211Orig1s004ltr.pdf | |
05/15/2014 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
08/16/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/20/2013 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/03/2016 | SUPPL-4 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202211Orig1s004lbl.pdf | |
01/25/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202211Orig1s000lbl.pdf |
OXYTROL FOR WOMEN
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
FILM, EXTENDED RELEASE;TRANSDERMAL; 3.9MG/24HR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
OXYTROL FOR WOMEN | OXYBUTYNIN | 3.9MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Over-the-counter | Yes | 202211 | ABBVIE |