Application 205629

Type: ANDA
Sponsor: OSMOTICA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	8MG	No	No
002	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	12MG	No	No
003	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	16MG	No	No
004	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	32MG	No	Yes
005	HYDROMORPHONE HYDROCHLORIDE	HYDROMORPHONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	24MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13811-701	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-701	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-701	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-701	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-701	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-702	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-702	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-702	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-702	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-702	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-703	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-703	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-703	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-703	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-703	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-704	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-704	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-704	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-704	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-704	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride	Trigen Laboratories, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44596	ORIG	2016-07-22
10480	ORIG	2016-07-11