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Last Updated: January 17, 2020

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 three 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. Six suppliers are listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.
Summary for 204785
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 63187-705-00 100 CAPSULE in 1 BOTTLE (63187-705-00)

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:

Boehringer Ingelheim
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