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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 080044


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NDA 080044 describes PROPOXYPHENE COMPOUND 65, which is a drug marketed by Ivax Sub Teva Pharms, Sandoz, and Teva, and is included in three NDAs. Additional details are available on the PROPOXYPHENE COMPOUND 65 profile page.

The generic ingredient in PROPOXYPHENE COMPOUND 65 is aspirin; caffeine; propoxyphene hydrochloride. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; caffeine; propoxyphene hydrochloride profile page.
Summary for 080044

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength389MG;32.4MG;65MG
Approval Date:Sep 16, 1983TE:RLD:Yes

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