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Last Updated: November 4, 2024

Suppliers and packages for tradename: BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

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BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	215138	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0650-25	100 CAPSULE in 1 BOTTLE (0054-0650-25)	2022-05-09
Hikma	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	215138	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3000-01	100 CAPSULE in 1 BOTTLE (0054-3000-01)	2022-05-09
Lgm Pharma	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	076560	ANDA	Actavis Pharma, Inc.	0591-2641-01	100 CAPSULE in 1 BOTTLE, PLASTIC (0591-2641-01)	2013-07-29
Lgm Pharma	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	076560	ANDA	Breckenridge Pharmaceutical, Inc.	51991-073-01	100 CAPSULE in 1 BOTTLE, PLASTIC (51991-073-01)	2004-07-01
Lgm Pharma	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	076560	ANDA	Actavis Pharma, Inc.	52544-082-01	100 CAPSULE in 1 BOTTLE, PLASTIC (52544-082-01)	2013-07-29
Lgm Pharma	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	076560	ANDA	Bryant Ranch Prepack	71335-0194-1	20 CAPSULE in 1 BOTTLE (71335-0194-1)	2004-07-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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