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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 207386

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NDA 207386 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 207386

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;50MG
Approval Date:	Nov 15, 2016	TE:	AA	RLD:	No

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