Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009149
Company: GLAXOSMITHKLINE

Products on NDA 009149

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No
THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No
THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No
THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No
THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No
THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No
THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SYRUP;ORAL	Discontinued	None	Yes	No
THORAZINE	CHLORPROMAZINE	25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SUPPOSITORY;RECTAL	Discontinued	None	Yes	No
THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CONCENTRATE;ORAL	Discontinued	None	Yes	No
THORAZINE	CHLORPROMAZINE	100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SUPPOSITORY;RECTAL	Discontinued	None	Yes	No
THORAZINE	CHLORPROMAZINE HYDROCHLORIDE	100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CONCENTRATE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009149

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/1957	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/1996	SUPPL-178	Manufacturing (CMC)		Label is not available on this site.
02/14/1992	SUPPL-173	Manufacturing (CMC)		Label is not available on this site.
04/22/1998	SUPPL-165	Labeling		Label is not available on this site.
08/19/1994	SUPPL-151	Manufacturing (CMC)-Formulation		Label is not available on this site.