Application 089450

Related Records

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	SOLUTION;ORAL	120MG/5ML;12MG/5ML	No	No

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46672-561	acetaminophen and codeine phosphate	acetaminophen and codeine phosphate	Mikart, LLC	ANDA	Current
46672-561	acetaminophen and codeine phosphate	acetaminophen and codeine phosphate	Mikart, Inc.	ANDA	Current
46672-561	acetaminophen and codeine phosphate	acetaminophen and codeine phosphate	Mikart, Inc.	ANDA	Current
46672-561	acetaminophen and codeine phosphate	acetaminophen and codeine phosphate	Mikart, LLC	ANDA	Current
46672-561	acetaminophen and codeine phosphate	acetaminophen and codeine phosphate	Mikart, LLC	ANDA	Current

Document	Submission type	Date
76115	ORIG	2023-11-02