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Details for New Drug Application (NDA): 087863

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NDA 087863 describes CHOLEDYL SA, which is a drug marketed by Warner Chilcott Llc and is included in two NDAs. Additional details are available on the CHOLEDYL SA profile page.

The generic ingredient in CHOLEDYL SA is oxtriphylline. There are three drug master file entries for this compound. Additional details are available on the oxtriphylline profile page.

Summary for NDA: 087863

Warner Chilcott Llc
Therapeutic Class:Respiratory Tract Agents

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:May 24, 1983TE:RLD:Yes

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.