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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 five 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. Seven suppliers are listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.

Summary for NDA: 204785

Tradename:
TREZIX
Applicant:
Wraser Pharms Llc
Ingredient:
acetaminophen; caffeine; dihydrocodeine bitartrate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 204785

Ingredient-typeXanthines
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 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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