Application 209410

Type: NDA
Sponsor: OSMOTICA PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 129MG BASE	Yes	No
002	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 193MG BASE	Yes	No
003	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 258MG BASE	Yes	Yes
004	OSMOLEX ER	AMANTADINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 161MG BASE	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68025-021	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-074	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-074	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-074	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-074	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-075	Osmolex ER	amantadine	Vertical Pharmaceuticals,	NDA	Current
68025-075	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-075	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-075	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-075	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-075	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-076	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-076	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-076	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-076	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-076	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-076	Osmolex ER	amantadine	Vertical Pharmaceuticals,	NDA	Current
68025-077	Osmolex ER	amantadine	Vertical Pharmaceuticals,	NDA	Current
68025-077	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-077	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-077	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
68025-077	Osmolex ER	amantadine	Vertical Pharmaceuticals, LLC	NDA	Current
70482-075	OSMOLEX ER	amantadine	Adamas Pharma, LLC	NDA	Current
70482-075	OSMOLEX ER	amantadine	Adamas Pharma, LLC	NDA	Current
70482-075	OSMOLEX ER	amantadine	Adamas Pharma, LLC	NDA	Current
70482-076	OSMOLEX ER	amantadine	Adamas Pharma, LLC	NDA	Current
70482-076	OSMOLEX ER	amantadine	Adamas Pharma, LLC	NDA	Current
70482-076	OSMOLEX ER	amantadine	Adamas Pharma, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82815	SUPPL	2025-07-11
82792	SUPPL	2025-07-11
57037	ORIG	2018-12-26
52699	ORIG	2018-02-23
52687	ORIG	2018-02-22

Application 209410

Related Records#

Application Products#

NDC Listings For This Application#

Documents#