Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 017924
Company: GLAXOSMITHKLINE

Products on NDA 017924

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAGAMET	CIMETIDINE HYDROCHLORIDE	EQ 300MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017924

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/16/1977	ORIG-1	Approval	Type 2 - New Active Ingredient	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Note
04/15/1997	SUPPL-59	Manufacturing (CMC)-Control	Label is not available on this site.
02/22/1995	SUPPL-58	Labeling	Label is not available on this site.
11/10/1993	SUPPL-57	Manufacturing (CMC)	Label is not available on this site.
06/08/1993	SUPPL-56	Manufacturing (CMC)	Label is not available on this site.
07/16/1992	SUPPL-54	Manufacturing (CMC)-Control	Label is not available on this site.
01/07/1992	SUPPL-53	Labeling	Label is not available on this site.
08/27/1992	SUPPL-52	Manufacturing (CMC)-Control	Label is not available on this site.
11/13/1991	SUPPL-50	Labeling	Label is not available on this site.
11/13/1989	SUPPL-49	Labeling	Label is not available on this site.
05/30/1990	SUPPL-47	Manufacturing (CMC)-Control	Label is not available on this site.
03/07/1991	SUPPL-46	Labeling	Label is not available on this site.
06/26/1989	SUPPL-45	Labeling	Label is not available on this site.
06/26/1989	SUPPL-44	Labeling	Label is not available on this site.
06/15/1988	SUPPL-42	Labeling	Label is not available on this site.
05/20/1988	SUPPL-41	Labeling	Label is not available on this site.
03/31/1988	SUPPL-40	Efficacy-New Dosing Regimen	Label is not available on this site.
04/23/1986	SUPPL-38	Labeling	Label is not available on this site.
01/13/1986	SUPPL-37	Labeling	Label is not available on this site.
05/15/1985	SUPPL-36	Labeling	Label is not available on this site.
04/18/1985	SUPPL-35	Labeling	Label is not available on this site.
02/07/1985	SUPPL-34	Labeling	Label is not available on this site.
04/29/1986	SUPPL-33	Efficacy-New Dosing Regimen	Label is not available on this site.
06/14/1984	SUPPL-32	Labeling	Label is not available on this site.
07/19/1984	SUPPL-31	Labeling	Label is not available on this site.
12/05/1984	SUPPL-30	Manufacturing (CMC)-Packaging	Label is not available on this site.
03/05/1984	SUPPL-29	Labeling	Label is not available on this site.
07/19/1984	SUPPL-27	Labeling	Label is not available on this site.
02/28/1983	SUPPL-25	Labeling	Label is not available on this site.
01/31/1983	SUPPL-24	Efficacy	Label is not available on this site.
03/11/1983	SUPPL-23	Manufacturing (CMC)	Label is not available on this site.
08/25/1982	SUPPL-22	Efficacy	Label is not available on this site.
01/22/1982	SUPPL-19	Labeling	Label is not available on this site.
12/30/1982	SUPPL-18	Labeling	Label is not available on this site.
11/02/1981	SUPPL-17	Labeling	Label is not available on this site.
07/13/1981	SUPPL-16	Labeling	Label is not available on this site.
06/12/1981	SUPPL-14	Manufacturing (CMC)-Formulation	Label is not available on this site.
01/22/1981	SUPPL-13	Labeling	Label is not available on this site.
01/22/1981	SUPPL-12	Labeling	Label is not available on this site.
12/30/1982	SUPPL-11	Efficacy	Label is not available on this site.
07/08/1980	SUPPL-10	Labeling	Label is not available on this site.
01/08/1980	SUPPL-8	Manufacturing (CMC)-Control	Label is not available on this site.