Application 202142

Type: ANDA
Sponsor: MIKART INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	SOLUTION;ORAL	300MG/5ML;10MG/5ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46672-648	oxycodone hydrochloride and acetaminophen	oxycodone hydrochloride and acetaminophen	Mikart, LLC	ANDA	Current
46672-648	oxycodone hydrochloride and acetaminophen	oxycodone hydrochloride and acetaminophen	Mikart, LLC	ANDA	Current
46672-648	oxycodone hydrochloride and acetaminophen	oxycodone hydrochloride and acetaminophen	Mikart, LLC	ANDA	Current
46672-648	oxycodone hydrochloride and acetaminophen	oxycodone hydrochloride and acetaminophen	Mikart, LLC	ANDA	Current
46672-648	oxycodone hydrochloride and acetaminophen	oxycodone hydrochloride and acetaminophen	Mikart, LLC	ANDA	Current
72245-648	Prolate	oxycodone hydrochloride and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-648	Prolate	oxycodone hydrochloride and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-648	Prolate	oxycodone hydrochloride and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72245-648	Prolate	oxycodone hydrochloride and acetaminophen	Forte Bio-Pharma LLC	ANDA	Current
72887-648	oxycodone hydrochloride and acetaminophen	oxycodone hydrochloride and acetaminophen	FH2 Pharma LLC	ANDA	Current
72887-648	oxycodone hydrochloride and acetaminophen	oxycodone hydrochloride and acetaminophen	FH2 Pharma LLC	ANDA	Current
72887-648	oxycodone hydrochloride and acetaminophen	oxycodone hydrochloride and acetaminophen	FH2 Pharma LLC	ANDA	Current
72887-648	oxycodone hydrochloride and acetaminophen	oxycodone hydrochloride and acetaminophen	FH2 Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76431	ORIG	2023-11-07
56845	ORIG	2018-12-20