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. Thirty-nine 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 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 5MG | ||||
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 | ||||
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| TABLET, EXTENDED RELEASE;ORAL | Strength | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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