Details for New Drug Application (NDA): 009268
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NDA 009268 describes CHOLEDYL, which is a drug marketed by Parke Davis and Warner Chilcott Llc and is included in three NDAs. Additional details are available on the CHOLEDYL profile page.
The generic ingredient in CHOLEDYL is oxtriphylline. There are three drug master file entries for this compound. Additional details are available on the oxtriphylline profile page.
The generic ingredient in CHOLEDYL is oxtriphylline. There are three drug master file entries for this compound. Additional details are available on the oxtriphylline profile page.
Summary for 009268
| Tradename: | CHOLEDYL |
| Applicant: | Parke Davis |
| Ingredient: | oxtriphylline |
| Patents: | 0 |
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 007
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 200MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 011
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 50MG/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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