Application 009149

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
007	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
011	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	INJECTABLE;INJECTION	25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
013	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
018	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
020	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	TABLET;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
022	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	SYRUP;ORAL	10MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
024	THORAZINE	CHLORPROMAZINE	SUPPOSITORY;RECTAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
032	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	CONCENTRATE;ORAL	30MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
033	THORAZINE	CHLORPROMAZINE	SUPPOSITORY;RECTAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
043	THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	CONCENTRATE;ORAL	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No