Details for New Drug Application (NDA): 078149

NDA 078149 describes BUTALBITAL, ASPIRIN AND CAFFEINE, which is a drug marketed by Lgm Pharma, Nostrum Labs Inc, Watson Labs, Actavis Elizabeth, Fosun Pharma, Halsey, Hikma Intl Pharms, Ivax Pharms, Puracap Pharm, Quantum Pharmics, and Strides Pharma, and is included in twelve NDAs. It is available from two suppliers. Additional details are available on the BUTALBITAL, ASPIRIN AND CAFFEINE profile page.

The generic ingredient in BUTALBITAL, ASPIRIN AND CAFFEINE is aspirin; butalbital; caffeine. 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 profile page.

Summary for 078149

Tradename:	BUTALBITAL, ASPIRIN AND CAFFEINE
Applicant:	Nostrum Labs Inc
Ingredient:	aspirin; butalbital; caffeine
Patents:	0

Pharmacology for NDA: 078149

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

Suppliers and Packaging for NDA: 078149

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	CAPSULE;ORAL	078149	ANDA	Nostrum Laboratories, Inc.	29033-215	29033-215-01	100 CAPSULE in 1 BOTTLE (29033-215-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	325MG;50MG;40MG
Approval Date:	Jun 13, 2007	TE:	AA	RLD:	No

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