Application 076855

Type: ANDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET;ORAL	8MG	No	No
002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET;ORAL	2MG	No	No
003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET;ORAL	4MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-3243	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3243	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3243	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3243	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3244	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3244	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3244	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3244	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3249	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3249	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3249	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
0406-3249	Hydromorphone Hydrochloride	hydromorphone hydrochloride	SpecGx LLC	ANDA	Current
60687-579	Hydromorphone Hydrochloride	hydromorphone hydrochloride	American Health Packaging	ANDA	Current
60687-579	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	American Health Packaging	ANDA	Current
60687-590	Hydromorphone Hydrochloride	hydromorphone hydrochloride	American Health Packaging	ANDA	Current
60687-590	Hydromorphone Hydrochloride	hydromorphone hydrochloride	American Health Packaging	ANDA	Current
67296-1414	Hydromorphone Hydrochloride	hydromorphone hydrochloride	RedPharm Drug, Inc.	ANDA	Current
71335-0229	Hydromorphone Hydrochloride	hydromorphone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0229	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0229	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0759	Hydromorphone Hydrochloride	hydromorphone hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0759	Hydromorphone Hydrochloride	hydromorphone hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76183	ORIG	2023-11-03