Details for New Drug Application (NDA): 075929
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The generic ingredient in BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE is acetaminophen; butalbital; caffeine; codeine phosphate. There are sixty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine; codeine phosphate profile page.
Summary for 075929
Tradename: | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE |
Applicant: | Nostrum Labs Inc |
Ingredient: | acetaminophen; butalbital; caffeine; codeine phosphate |
Patents: | 0 |
Pharmacology for NDA: 075929
Mechanism of Action | Full Opioid Agonists |
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 075929
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | acetaminophen; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 075929 | ANDA | Bryant Ranch Prepack | 71335-0653 | 71335-0653-1 | 20 CAPSULE in 1 BOTTLE (71335-0653-1) |
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | acetaminophen; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 075929 | ANDA | Bryant Ranch Prepack | 71335-0653 | 71335-0653-2 | 90 CAPSULE in 1 BOTTLE (71335-0653-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 325MG;50MG;40MG;30MG | ||||
Approval Date: | Apr 22, 2002 | TE: | RLD: | No |
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