Details for New Drug Application (NDA): 211106

NDA 211106 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 211106

Tradename:	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Applicant:	Abhai Llc
Ingredient:	acetaminophen; butalbital; caffeine
Patents:	0

Pharmacology for NDA: 211106

Physiological Effect

Central Nervous System Stimulation

Suppliers and Packaging for NDA: 211106

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	211106	ANDA	KVK-Tech, Inc.	10702-253	10702-253-01	100 TABLET in 1 BOTTLE (10702-253-01)
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	211106	ANDA	KVK-Tech, Inc.	10702-253	10702-253-50	500 TABLET in 1 BOTTLE (10702-253-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;50MG;40MG
Approval Date:	Sep 26, 2018	TE:	AA	RLD:	No

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