Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011127
Company: GLAXOSMITHKLINE

Products on NDA 011127

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COMPAZINE	PROCHLORPERAZINE	5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SUPPOSITORY;RECTAL	Discontinued	None	No	No
COMPAZINE	PROCHLORPERAZINE	25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SUPPOSITORY;RECTAL	Discontinued	None	No	No
COMPAZINE	PROCHLORPERAZINE	2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SUPPOSITORY;RECTAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011127

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/1959	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2001	SUPPL-61	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf
05/09/1997	SUPPL-60	Manufacturing (CMC)-Control		Label is not available on this site.
08/11/1994	SUPPL-59	Manufacturing (CMC)-Control		Label is not available on this site.
02/14/1992	SUPPL-57	Manufacturing (CMC)		Label is not available on this site.
08/21/1979	SUPPL-28	Labeling		Label is not available on this site.