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Last Updated: December 26, 2024

Details for New Drug Application (NDA): 088825

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NDA 088825 describes BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, which is a drug marketed by Aurolife Pharma Llc, Dr Reddys Labs Sa, Gilbert Labs, Graham Dm, Granules, Hikma, Key Therap, Lannett Co Inc, Lgm Pharma, Mallinckrodt, Novast Labs, Nuvo Pharms Inc, Quagen, Senores Pharms, Taro, Mikart, Abhai Llc, Able, Actavis Labs Ut Inc, Alvogen, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Sun Pharm Industries, Vintage Pharms, and Watson Labs, and is included in forty-five NDAs. It is available from thirty-seven suppliers. Additional details are available on the BUTALBITAL, ACETAMINOPHEN AND CAFFEINE profile page.

The generic ingredient in BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is acetaminophen; butalbital; caffeine. There are sixty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.

Summary for 088825

Tradename:	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Applicant:	Gilbert Labs
Ingredient:	acetaminophen; butalbital; caffeine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 5, 1984	TE:		RLD:	Yes

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