Application 019429

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	FIORINAL W/CODEINE	ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	CAPSULE;ORAL	325MG;50MG;40MG;30MG	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-6010	Fiorinal with Codeine	Butalbital, Aspirin, Caffeine, and Codeine Phosphate	Allergan, Inc.	NDA	Current
0023-6010	Fiorinal with Codeine	Butalbital, Aspirin, Caffeine, and Codeine Phosphate	Allergan, Inc.	NDA	Current
0023-6010	Fiorinal with Codeine	Butalbital, Aspirin, Caffeine, and Codeine Phosphate	Allergan, Inc.	NDA	Current
0023-6010	Fiorinal with Codeine	Butalbital, Aspirin, Caffeine, and Codeine Phosphate	Allergan, Inc.	NDA	Current
0591-3546	Butalbital, Aspirin, Caffeine and Codeine Phosphate	Butalbital, Aspirin, Caffeine and Codeine Phosphate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3546	Butalbital, Aspirin, Caffeine and Codeine Phosphate	Butalbital, Aspirin, Caffeine and Codeine Phosphate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3546	Butalbital, Aspirin, Caffeine and Codeine Phosphate	Butalbital, Aspirin, Caffeine and Codeine Phosphate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3546	Butalbital, Aspirin, Caffeine and Codeine Phosphate	Butalbital, Aspirin, Caffeine and Codeine Phosphate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3546	Butalbital, Aspirin, Caffeine and Codeine Phosphate	Butalbital, Aspirin, Caffeine and Codeine Phosphate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
52544-956	Fiorinal with Codeine	Butalbital, Aspirin, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	NDA	Current