Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011000
Company: GLAXOSMITHKLINE

Products on NDA 011000

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COMPAZINE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
COMPAZINE	PROCHLORPERAZINE MALEATE	EQ 15MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
COMPAZINE	PROCHLORPERAZINE MALEATE	EQ 30MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
COMPAZINE	PROCHLORPERAZINE MALEATE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011000

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/1957	ORIG-1	Approval	Type 3 - New Dosage Form	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-84	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf
08/21/1979	SUPPL-46	Labeling		Label is not available on this site.