Application 208593

Type: ANDA
Sponsor: ABHAI LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	SOLUTION;ORAL	5MG/5ML	No	No
002	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	SOLUTION;ORAL	100MG/5ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10702-171	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	KVK-Tech, Inc.	ANDA	Current
10702-171	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	KVK-Tech, Inc.	ANDA	Current
10702-183	Oxycodone Hydrochloride	Oxycodone Hydrochloride	KVK-Tech, Inc.	ANDA	Current
10702-183	Oxycodone Hydrochloride	Oxycodone Hydrochloride	KVK-Tech, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76295	ORIG	2023-11-03
49080	ORIG	2017-07-25