Application 211749

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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
67877-625	Oxycodone	Oxycodone	Ascend Laboratories, LLC	ANDA	Current
67877-625	Oxycodone	Oxycodone	Ascend Laboratories, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76436	ORIG	2023-11-07