Application 090415

Type: ANDA
Sponsor: VINTAGE PHARMS

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 Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64376-643	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical	ANDA	Current
64376-643	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
64376-643	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical	ANDA	Current
64376-643	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical	ANDA	Current
64376-648	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical	ANDA	Current
64376-648	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
64376-648	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical	ANDA	Current
64376-648	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical	ANDA	Current
64376-649	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical	ANDA	Current
64376-649	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical, Inc.	ANDA	Current
64376-649	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical	ANDA	Current
64376-649	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	Par Pharmaceutical	ANDA	Current
76519-1079	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	H.J. Harkins Company, Inc.	ANDA	Current
76519-1081	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	H.J. Harkins Company, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76188	ORIG	2023-11-03