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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085100

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NDA 085100 describes DOLENE AP-65, which is a drug marketed by Lederle and is included in one NDA. Additional details are available on the DOLENE AP-65 profile page.

The generic ingredient in DOLENE AP-65 is acetaminophen; propoxyphene hydrochloride. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; propoxyphene hydrochloride profile page.
Summary for 085100
Tradename:DOLENE AP-65
Applicant:Lederle
Ingredient:acetaminophen; propoxyphene hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength650MG;65MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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