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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021793
Company: MEDA PHARMS

Medication Guide

Products on NDA 021793

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REGLAN ODT	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No
REGLAN ODT	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021793

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021793lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021793ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021793s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2011	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021793s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021793s011ltr.pdf
08/02/2011	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021793s009ltr.pdf
11/18/2010	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021793s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017854s055,021793s008ltr.pdf
09/09/2010	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021793s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021793s007ltr.pdf
09/04/2009	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s052_021793s005ltr.pdf
06/30/2009	SUPPL-4	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s051,021793s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017854s051,021793s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021793_s004a_reglan tablets.pdf

Labels for NDA 021793

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2011	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021793s011lbl.pdf
11/18/2010	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021793s008lbl.pdf
09/09/2010	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021793s007lbl.pdf
06/30/2009	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017854s051,021793s004lbl.pdf
06/10/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021793lbl.pdf

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