Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070581
Company: STRIDES PHARMA INTL

Products on ANDA 070581

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070581

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/1985	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
07/30/2019	SUPPL-44	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/21/2012	SUPPL-38	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/28/2011	SUPPL-37	Labeling-Package Insert, REMS-Proposal, Labeling-Medication Guide		Label is not available on this site.
03/11/2010	SUPPL-35	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/05/2005	SUPPL-27	Labeling		Label is not available on this site.
05/23/2002	SUPPL-22	Labeling		Label is not available on this site.
11/02/2001	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
02/01/2002	SUPPL-20	Labeling		Label is not available on this site.
05/26/2000	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
11/24/1999	SUPPL-18	Labeling		Label is not available on this site.
01/27/2000	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/18/1996	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
03/28/1991	SUPPL-15	Labeling		Label is not available on this site.
07/10/1991	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
11/01/1988	SUPPL-12	Labeling		Label is not available on this site.
11/23/1987	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
09/15/1986	SUPPL-9	Labeling		Label is not available on this site.
06/23/1987	SUPPL-6	Labeling		Label is not available on this site.
06/15/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/15/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/15/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
11/25/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/25/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.