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Generated: September 19, 2018

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Details for New Drug Application (NDA): 040688

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NDA 040688 describes ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, which is a drug marketed by Mikart, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp, and is included in five NDAs. It is available from one supplier. Additional details are available on the ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE profile page.

The generic ingredient in ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.
Pharmacology for NDA: 040688
Ingredient-typeXanthines
Mechanism of ActionFull Opioid Agonists
Physiological EffectCentral Nervous System Stimulation
Suppliers and Packaging for NDA: 040688
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE acetaminophen; caffeine; dihydrocodeine bitartrate CAPSULE;ORAL 040688 ANDA WraSer LLC 66992-340 66992-340-10 100 CAPSULE in 1 BOTTLE (66992-340-10)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength356.4MG;30MG;16MG
Approval Date:Apr 3, 2007TE:RLD:No

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