Application 017105

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRANXENE	CLORAZEPATE DIPOTASSIUM	CAPSULE;ORAL	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	TRANXENE	CLORAZEPATE DIPOTASSIUM	CAPSULE;ORAL	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
003	TRANXENE	CLORAZEPATE DIPOTASSIUM	CAPSULE;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
004	TRANXENE SD	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	22.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
005	TRANXENE SD	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	11.25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
006	TRANXENE	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
007	TRANXENE	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	7.5MG	Yes	No
008	TRANXENE	CLORAZEPATE DIPOTASSIUM	TABLET;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55292-304	Tranxene	clorazepate dipotassium	Recordati Rare Diseases, Inc.	NDA	Current
55292-304	Tranxene	clorazepate dipotassium	Recordati Rare Diseases Inc.	NDA	Current
55292-304	Tranxene	clorazepate dipotassium	RECORDATI RARE DISEASES,	NDA	Current
55292-304	Tranxene	clorazepate dipotassium	RECORDATI RARE DISEASES, INC.	NDA	Current
55292-304	Tranxene	clorazepate dipotassium	RECORDATI RARE DISEASES, INC.	NDA	Current