Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021019
Company: GLAXOSMITHKLINE

Products on NDA 021019

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021019

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/1999	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21019A_Compazine_appltrs_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21019A_Compazine_appltrs_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21019a.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2001	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf

Labels for NDA 021019

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/06/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21019A_Compazine_appltrs_prntlbl.pdf