Application 215138

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	CAPSULE;ORAL	325MG;50MG;40MG;30MG	No	No
002	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	CAPSULE;ORAL	300MG;50MG;40MG;30MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0650	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0650	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-3000	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-3000	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Hikma Pharmaceuticals USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76483	ORIG	2023-11-07