Application 207537

Type: ANDA
Sponsor: PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	SOLUTION;ORAL	5MG/5ML	No	No
002	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	SOLUTION;ORAL	10MG/5ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-6221	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	SpecGx LLC	ANDA	Current
0406-6225	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	SpecGx LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76449	ORIG	2023-11-07