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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 205120

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NDA 205120 describes BUTALBITAL AND ACETAMINOPHEN, which is a drug marketed by Dr Reddys Labs Sa, Granules, Alvogen, Halsey, Larken Labs Inc, Lgm Pharma, Mikart, Ne Rx Pharma, Quagen, Senores Pharms, and Watson Labs, and is included in thirteen NDAs. It is available from nine suppliers. Additional details are available on the BUTALBITAL AND ACETAMINOPHEN profile page.

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

Summary for 205120

Tradename:	BUTALBITAL AND ACETAMINOPHEN
Applicant:	Alvogen
Ingredient:	acetaminophen; butalbital
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	325MG;50MG
Approval Date:	Oct 30, 2015	TE:		RLD:	No

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