Application 205327

Type: ANDA
Sponsor: OSMOTICA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	18MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	27MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	36MG	No	No
004	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	54MG	No	No
005	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	72MG	No	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13811-706	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-706	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-706	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-706	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-707	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-707	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-707	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-707	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-708	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-708	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-708	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-708	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-709	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-709	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-709	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-709	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-710	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-710	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-710	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
13811-710	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Trigen Laboratories, LLC	ANDA	Current
63629-2459	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2459	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2459	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2460	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2460	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2460	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2461	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2461	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2461	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2462	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2462	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2462	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2463	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2463	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2463	Methylphenidate Hydrochloride	Methylphenidate hydrochloride	Bryant Ranch Prepack	ANDA	Current
68025-084	RELEXXII	methylphenidate hydrochloride	Vertical Pharmaceuticals, LLC	ANDA	Current
68025-084	RELEXXII	methylphenidate hydrochloride	Vertical Pharmaceuticals, LLC	ANDA	Current
68025-084	RELEXXII	methylphenidate hydrochloride	Vertical Pharmaceuticals, LLC	ANDA	Current
68025-084	RELEXXII	methylphenidate hydrochloride	Vertical Pharmaceuticals, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49511	ORIG	2017-08-22
49194	ORIG	2017-08-02

Application 205327

Related Records#

Application Products#

NDC Listings For This Application#

Documents#