Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010571
Company: GLAXOSMITHKLINE

Products on NDA 010571

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COMPAZINE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
COMPAZINE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
COMPAZINE	PROCHLORPERAZINE MALEATE	EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010571

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/23/1956	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
08/03/2005	SUPPL-96	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010571s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010571s096ltr.pdf
04/03/2001	SUPPL-95	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf
09/30/1992	SUPPL-86	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/21/1979	SUPPL-58	Labeling		Label is not available on this site.

Labels for NDA 010571

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/03/2005	SUPPL-96	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010571s096lbl.pdf