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Generated: December 15, 2018

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Details for New Drug Application (NDA): 085685

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NDA 085685 describes PROVAL #3, which is a drug marketed by Solvay and is included in one NDA. Additional details are available on the PROVAL #3 profile page.

The generic ingredient in PROVAL #3 is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.
Summary for 085685
Tradename:PROVAL #3
Applicant:Solvay
Ingredient:acetaminophen; codeine phosphate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength325MG;30MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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