Application 209822

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIGABATRIN	VIGABATRIN	TABLET;ORAL	500MG	No	No

Orange Book products#

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209822-001	VIGABATRIN	VIGABATRIN	500MG	TABLET / ORAL	AB		2019-01-14

Therapeutic equivalence codes#

Application-product, TE code table
Application-product	TE code
A209822-001	AB

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3851	Vigabatrin	Vigabatrin	Actavis Pharma, Inc.	ANDA	Current
0591-3851	Vigabatrin	Vigabatrin	Actavis Pharma, Inc.	ANDA	Current
0591-3851	Vigabatrin	Vigabatrin	Actavis Pharma, Inc.	ANDA	Current
0591-3851	Vigabatrin	Vigabatrin	Actavis Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76528	ORIG	2023-11-08
65833	ORIG	2021-01-06
57720	ORIG	2019-02-21