Application 208295

Type: ANDA
Sponsor: WATSON LABS TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALVIMOPAN	ALVIMOPAN	CAPSULE;ORAL	12MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2312	Alvimopan	Alvimopan	Actavis Pharma, Inc.	ANDA	Current
0591-2312	Alvimopan	Alvimopan	Actavis Pharma, Inc.	ANDA	Current
0591-2312	Alvimopan	Alvimopan	Actavis Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83453	SUPPL	2025-09-25
76420	ORIG	2023-11-06
62184	ORIG	2020-03-18