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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Johnson and Johnson
Fish and Richardson
US Army
Express Scripts

Generated: January 22, 2018

DrugPatentWatch Database Preview

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 five suppliers. Additional details are available on the TREZIX profile page.

The generic ingredient in TREZIX is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six 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 204785
Applicant:Wraser Pharms Llc
Ingredient:acetaminophen; caffeine; dihydrocodeine bitartrate
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
TREZIX acetaminophen; caffeine; dihydrocodeine bitartrate CAPSULE;ORAL 204785 ANDA XSPIRE PHARMA LLC 42195-840 42195-840-10 100 CAPSULE in 1 BOTTLE (42195-840-10)
TREZIX acetaminophen; caffeine; dihydrocodeine bitartrate CAPSULE;ORAL 204785 ANDA Proficient Rx LP 63187-705 63187-705-60 60 CAPSULE in 1 BOTTLE (63187-705-60)

Profile 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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Serving leading biopharmaceutical companies globally:

Harvard Business School
Farmers Insurance
Fish and Richardson

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