Details for New Drug Application (NDA): 204785
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NDA 204785 describes TREZIX, which is a drug marketed by Key Therap and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.
The generic ingredient in TREZIX is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.
Summary for 204785
| Tradename: | TREZIX |
| Applicant: | Key Therap |
| Ingredient: | acetaminophen; caffeine; dihydrocodeine bitartrate |
| Patents: | 0 |
Pharmacology for NDA: 204785
| Mechanism of Action | Full Opioid Agonists |
| Physiological Effect | Central 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 | Proficient Rx LP | 63187-705 | 63187-705-00 | 100 CAPSULE in 1 BOTTLE (63187-705-00) |
| TREZIX | acetaminophen; caffeine; dihydrocodeine bitartrate | CAPSULE;ORAL | 204785 | ANDA | Proficient Rx LP | 63187-705 | 63187-705-30 | 30 CAPSULE in 1 BOTTLE (63187-705-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 320.5MG;30MG;16MG | ||||
| Approval Date: | Nov 26, 2014 | TE: | RLD: | No | |||||
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