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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 215047

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NDA 215047 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, Genus, Abhai Llc, Able, Actavis Labs Ut Inc, Alvogen, Anda Repository, Hikma Pharms, Mikart, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Strides Pharma Intl, Sun Pharm Industries, Vintage Pharms, and Watson Labs, and is included in forty-five NDAs. It is available from thirty-six 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-six suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.

Summary for 215047

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	300MG;50MG;40MG
Approval Date:	Nov 17, 2021	TE:	AA	RLD:	No

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