Details for New Drug Application (NDA): 076560
✉ Email this page to a colleague
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 076560
Tradename: | BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE |
Applicant: | Lgm Pharma |
Ingredient: | acetaminophen; butalbital; caffeine; codeine phosphate |
Patents: | 0 |
Pharmacology for NDA: 076560
Mechanism of Action | Full Opioid Agonists |
Physiological Effect | Central Nervous System Stimulation |
Suppliers and Packaging for NDA: 076560
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 | 076560 | ANDA | Actavis Pharma, Inc. | 0591-2641 | 0591-2641-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2641-01) |
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | acetaminophen; butalbital; caffeine; codeine phosphate | CAPSULE;ORAL | 076560 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-073 | 51991-073-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (51991-073-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 325MG;50MG;40MG;30MG | ||||
Approval Date: | Jun 10, 2004 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG;50MG;40MG;30MG | ||||
Approval Date: | Jul 19, 2012 | TE: | AB | RLD: | No |
Complete Access Available with Subscription