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Generated: May 30, 2017

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Details for New Drug Application (NDA): 204785

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NDA 204785 describes TREZIX, which is a drug marketed by Wraser Pharms Llc and is included in one NDA. It is available from six suppliers. Additional details are available on the TREZIX profile page.

The generic ingredient in TREZIX is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.

Summary for NDA: 204785

Formulation / Manufacturing:see details

Pharmacology for NDA: 204785

Mechanism of ActionFull Opioid Agonists
Physiological EffectCentral Nervous System Stimulation

Suppliers and Packaging for NDA: 204785

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
acetaminophen; caffeine; dihydrocodeine bitartrate
CAPSULE;ORAL 204785 ANDA XSPIRE PHARMA LLC 42195-840 42195-840-10 100 CAPSULE in 1 BOTTLE (42195-840-10)
acetaminophen; caffeine; dihydrocodeine bitartrate
CAPSULE;ORAL 204785 ANDA Medsource Pharmaceuticals 45865-866 45865-866-30 30 CAPSULE in 1 BOTTLE (45865-866-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength320.5MG;30MG;16MG
Approval Date:Nov 26, 2014TE:RLD:No

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