Details for New Drug Application (NDA): 017577
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NDA 017577 describes DITROPAN, which is a drug marketed by Ortho Mcneil Janssen and Janssen Pharms and is included in three NDAs. Additional details are available on the DITROPAN profile page.
The generic ingredient in DITROPAN 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.
The generic ingredient in DITROPAN 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 017577
| Tradename: | DITROPAN |
| Applicant: | Janssen Pharms |
| Ingredient: | oxybutynin chloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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