Application 207808

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	300MG;5MG	No	No
002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	300MG;7.5MG	No	No
003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	300MG;10MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42858-040	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE and ACETAMINOPHEN	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-040	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE and ACETAMINOPHEN	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-040	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE and ACETAMINOPHEN	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-139	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE and ACETAMINOPHEN	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-139	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE and ACETAMINOPHEN	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-139	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE and ACETAMINOPHEN	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-238	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE and ACETAMINOPHEN	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-238	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE and ACETAMINOPHEN	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-238	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE and ACETAMINOPHEN	Rhodes Pharmaceuticals L.P.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
76167	ORIG	2023-11-03