Application 210644

Type: ANDA
Sponsor: ABHAI LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;2.5MG	No	No
002	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;5MG	No	No
003	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;7.5MG	No	No
004	OXYCODONE AND ACETAMINOPHEN	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;10MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10702-184	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-184	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-184	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-184	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-184	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-185	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-185	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-185	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-185	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-185	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-186	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-186	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-186	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-186	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-186	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-187	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-187	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-187	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-187	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current
10702-187	Oxycodone and Acetaminophen	Oxycodone and Acetaminophen	KVK-Tech, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76064	ORIG	2023-11-02