Application 011145

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DIURIL	CHLOROTHIAZIDE	TABLET;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	DIURIL	CHLOROTHIAZIDE	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	DIURIL	CHLOROTHIAZIDE SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-419	Chlorothiazide Sodium	Chlorothiazide Sodium	Akorn, Inc.	NDA AUTHORIZED GENERIC	Current
17478-419	Chlorothiazide Sodium	Chlorothiazide Sodium	Akorn	NDA AUTHORIZED GENERIC	Current
17478-419	Chlorothiazide Sodium	Chlorothiazide Sodium	Akorn	NDA AUTHORIZED GENERIC	Current
17478-419	Chlorothiazide Sodium	Chlorothiazide Sodium	Akorn, Inc.	NDA AUTHORIZED GENERIC	Current
17478-419	Chlorothiazide Sodium	Chlorothiazide Sodium	Akorn, Inc.	NDA AUTHORIZED GENERIC	Current
76478-711	Sodium Diuril	chlorothiazide sodium	Akorn	NDA	Current
76478-711	Sodium Diuril	chlorothiazide sodium	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)	NDA	Current
76478-711	Sodium Diuril	chlorothiazide sodium	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)	NDA	Current
76478-711	Sodium Diuril	chlorothiazide sodium	Akorn	NDA	Current
76478-711	Sodium Diuril	chlorothiazide sodium	Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)	NDA	Current