Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074703
Company: PHARMOBEDIENT CNSLTG

• Medication Guide

Products on ANDA 074703

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/5ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074703

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/1997	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/08/2014	SUPPL-10	Labeling-Medication Guide		Label is not available on this site.
02/15/2011	SUPPL-9	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/074703s009ltr.pdf
02/17/2011	SUPPL-8	Labeling		Label is not available on this site.
09/15/2009	SUPPL-7	Labeling, REMS-Proposal	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/074703s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/074703Orig1s007.pdf
06/30/2009	SUPPL-6	Labeling, REMS-Proposal	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/074703Orig1s006.pdf
05/16/2012	SUPPL-5	Labeling		Label is not available on this site.
08/18/2003	SUPPL-4	Labeling		Label is not available on this site.
07/12/2002	SUPPL-3	Labeling		Label is not available on this site.
12/20/2001	SUPPL-2	Labeling		Label is not available on this site.
09/21/2000	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.