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Generated: December 13, 2018

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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.
Summary for 009268
Tradename:CHOLEDYL
Applicant:Parke Davis
Ingredient:oxtriphylline
Patents:0
Formulation / Manufacturing:see details

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 007

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrength200MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 011

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength50MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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