Details for New Drug Application (NDA): 074951

NDA 074951 describes BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, which is a drug marketed by Dr Reddys Labs Sa, Lgm Pharma, Stevens J, Strides Pharma, and Watson Labs, and is included in five NDAs. It is available from five suppliers. Additional details are available on the BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE profile page.

The generic ingredient in BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE is aspirin; butalbital; caffeine; codeine phosphate. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine; codeine phosphate profile page.

Summary for 074951

Tradename:	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
Applicant:	Stevens J
Ingredient:	aspirin; butalbital; caffeine; codeine phosphate
Patents:	0

Pharmacology for NDA: 074951

Mechanism of Action	Cyclooxygenase Inhibitors Full Opioid Agonists
Physiological Effect	Central Nervous System Stimulation Decreased Platelet Aggregation Decreased Prostaglandin Production

Suppliers and Packaging for NDA: 074951

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	074951	ANDA	Lannett Company, Inc.	0527-1312	0527-1312-01	100 CAPSULE in 1 BOTTLE (0527-1312-01)
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	074951	ANDA	Amneal Pharmaceuticals of New York, LLC	69238-1993	69238-1993-1	100 CAPSULE in 1 BOTTLE (69238-1993-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	325MG;50MG;40MG;30MG
Approval Date:	Aug 31, 1998	TE:	AB	RLD:	No

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