Details for New Drug Application (NDA): 020897
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The generic ingredient in DITROPAN XL is oxybutynin chloride. There are sixteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.
Summary for 020897
Tradename: | DITROPAN XL |
Applicant: | Janssen Pharms |
Ingredient: | oxybutynin chloride |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 16, 1998 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 16, 1998 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jun 22, 1999 | TE: | RLD: | Yes |
Expired US Patents for NDA 020897
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