Application 077723

Type: ANDA
Sponsor: VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	TABLET;ORAL	7.5MG;200MG	No	No
002	HYDROCODONE BITARTRATE AND IBUPROFEN	HYDROCODONE BITARTRATE; IBUPROFEN	TABLET;ORAL	10MG;200MG	No	No
003	HYDROCODONE	HYDROCODONE BITARTRATE; IBUPROFEN	TABLET;ORAL	5MG;200MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-3586	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical, Inc.	ANDA	Current
0603-3586	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
0603-3586	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
0603-3586	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
0603-3897	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
0603-3897	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
0603-3897	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Par Pharmaceutical	ANDA	Current
50991-579	IBUDONE	hydrocodone bitartrate and ibuprofen	Poly Pharmaceuticals	ANDA	Current
55700-639	Hydrocodone Bitartrate and Ibuprofen	hydrocodone bitartrate and ibuprofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-296	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	DIRECT RX	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76162	ORIG	2023-11-03