Application Information

This drug has been submitted to the FDA under the reference 085685/001.

Names and composition

"PROVAL #3" is the commercial name of a drug composed of ACETAMINOPHEN and CODEINE PHOSPHATE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
085685/001 PROVAL #3 ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE/ORAL 325MG and 30MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
040098/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE SOLUTION/ORAL 120MG per 5ML and 12MG per 5ML
040119/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE SOLUTION/ORAL 120MG per 5ML and 12MG per 5ML
040223/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
040223/002 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
040223/003 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
040419/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
040419/002 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
040419/003 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
040441/001 CODRIX ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 500MG and 30MG
040443/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
040443/002 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
040443/003 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
040447/001 CODRIX ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 500MG and 15MG
040452/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
040459/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
040488/001 CODRIX ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 500MG and 60MG
040779/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
081249/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
081250/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
083643/001 CAPITAL AND CODEINE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 325MG and 30MG
083871/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
083872/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
083951/001 EMPRACET W/ CODEINE PHOSPHATE #3 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
083951/002 EMPRACET W/ CODEINE PHOSPHATE #4 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
084360/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
084444/001 PHENAPHEN W/ CODEINE NO. 2 ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE/ORAL 325MG and 15MG
084445/001 PHENAPHEN W/ CODEINE NO. 3 ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE/ORAL 325MG and 30MG
084446/001 PHENAPHEN W/ CODEINE NO. 4 ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE/ORAL 325MG and 60MG
084656/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
084659/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
084667/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
085055/001 TYLENOL W/ CODEINE NO. 1 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 7.5MG
085055/002 TYLENOL W/ CODEINE NO. 2 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
085055/003 TYLENOL W/ CODEINE NO. 3 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
085055/004 TYLENOL W/ CODEINE NO. 4 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
085056/001 TYLENOL W/ CODEINE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 325MG and 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
085056/002 TYLENOL W/ CODEINE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 325MG and 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
085056/003 TYLENOL W/ CODEINE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 325MG and 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
085056/004 TYLENOL W/ CODEINE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 325MG and 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
085057/001 TYLENOL W/ CODEINE ACETAMINOPHEN; CODEINE PHOSPHATE SOLUTION/ORAL 120MG per 5ML and 12MG per 5ML
085217/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 325MG and 30MG
085218/002 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
085288/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
085291/002 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
085363/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 325MG and 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
085364/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 325MG and 15MG
085365/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
085607/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
085676/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
085685/001 PROVAL #3 ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE/ORAL 325MG and 30MG
085794/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
085795/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
085856/001 PHENAPHEN-650 W/ CODEINE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 650MG and 30MG
085861/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE SOLUTION/ORAL 120MG per 5ML and 12MG per 5ML
085868/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
085883/001 CAPITAL AND CODEINE ACETAMINOPHEN; CODEINE PHOSPHATE SUSPENSION/ORAL 120MG per 5ML and 12MG per 5ML
085896/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
085917/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
085964/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
085992/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
086024/001 CAPITAL AND CODEINE ACETAMINOPHEN; CODEINE PHOSPHATE SUSPENSION/ORAL 120MG per 5ML and 12MG per 5ML
086366/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE SOLUTION/ORAL 120MG per 5ML and 12MG per 5ML
086549/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
086681/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
086683/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
087006/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE SOLUTION/ORAL 120MG per 5ML and 12MG per 5ML
087083/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
087141/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
087275/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
087276/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
087277/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
087306/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
087421/001 TYLENOL W/ CODEINE NO. 4 ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE/ORAL 300MG and 60MG
087422/001 TYLENOL W/ CODEINE NO. 3 ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE/ORAL 300MG and 30MG
087423/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
087433/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
087508/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE SOLUTION/ORAL 120MG per 5ML and 12MG per 5ML
087653/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
087762/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
087919/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
087920/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
088037/001 PAPA-DEINE #3 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
088324/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE/ORAL 300MG and 30MG
088353/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
088354/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
088355/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
088537/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE/ORAL 300MG and 15MG
088599/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE/ORAL 300MG and 60MG
088627/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
088628/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
088629/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
088715/001 PAPA-DEINE #4 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
089080/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
089183/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
089184/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
089185/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
089231/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 650MG and 30MG
089238/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
089244/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
089253/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
089254/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
089363/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 650MG and 60MG
089450/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE SOLUTION/ORAL 120MG per 5ML and 12MG per 5ML
089478/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
089479/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
089480/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
089481/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
089482/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
089483/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
089511/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 500MG and 15MG
089512/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 500MG and 30MG
089513/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 500MG and 60MG
089671/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
089672/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
089673/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
089805/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
089828/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
089990/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
089997/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
089998/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
089999/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG
091238/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE SOLUTION/ORAL 120MG per 5ML and 12MG per 5ML
202800/001 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 15MG
202800/002 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 30MG
202800/003 ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE TABLET/ORAL 300MG and 60MG

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