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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 086231

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NDA 086231 describes BUTALBITAL, ASPIRIN AND CAFFEINE, which is a drug marketed by Lgm Pharma, Mpp Pharma, 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 three 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. Six suppliers are listed for this compound. Additional details are available on the aspirin; butalbital; caffeine profile page.

Summary for 086231

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

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	325MG;50MG;40MG
Approval Date:	Feb 12, 1985	TE:		RLD:	No

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