Application 040482

Type: ANDA
Sponsor: ANDA REPOSITORY

Related Records

Company: ANDA REPOSITORY

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	SOLUTION;ORAL	325MG/15ML;7.5MG/15ML	No	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0703	Hycet	Hydrocodone bitartrate and acetaminophen	G&W Laboratories, Inc.	ANDA	Current
0713-0704	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate and acetaminophen	G&W Laboratories, Inc.	ANDA	Current
46672-642	hydrocodone bitartrate and acetaminophen	hydrocodone bitartrate and acetaminophen	Mikart, LLC	ANDA	Current
46672-642	hydrocodone bitartrate and acetaminophen	hydrocodone bitartrate and acetaminophen	Mikart, LLC	ANDA	Current
46672-642	hydrocodone bitartrate and acetaminophen	hydrocodone bitartrate and acetaminophen	Mikart, LLC	ANDA	Current
46672-642	hydrocodone bitartrate and acetaminophen	hydrocodone bitartrate and acetaminophen	Mikart, LLC	ANDA	Current

Documents

Document	Submission type	Date
76116	ORIG	2023-11-03