Application 202509

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	CAPSULE;ORAL	0.5MG;0.4MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10370-280	Dutasteride and Tamsulosin Hydrochloride	Dutasteride and Tamsulosin Hydrochloride Capsules	Par Pharmaceutical, Inc.	ANDA	Current
10370-280	Dutasteride and Tamsulosin Hydrochloride	Dutasteride and Tamsulosin Hydrochloride Capsules	Par Pharmaceutical, Inc.	ANDA	Current
10370-280	Dutasteride and Tamsulosin Hydrochloride	Dutasteride and Tamsulosin Hydrochloride Capsules	Par Pharmaceutical, Inc.	ANDA	Current
10370-280	Dutasteride and Tamsulosin Hydrochloride	Dutasteride and Tamsulosin Hydrochloride Capsules	Par Pharmaceutical, Inc.	ANDA	Current
10370-280	Dutasteride and Tamsulosin Hydrochloride	Dutasteride and Tamsulosin Hydrochloride Capsules	Par Pharmaceutical, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
10058	ORIG	2014-02-27