Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078293
Company: MYLAN PHARMS INC
Company: MYLAN PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| Oxybutynin Chloride | Oxybutynin Chloride | 15 MG. | TABLET, EXTENDED RELEASE; ORAL | Prescription | TBD | TBD | 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 |
|---|---|---|---|---|---|---|---|
| 05/10/2007 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/078293Orig1s000.pdf |
Oxybutynin Chloride
There are no Therapeutic Equivalents.