Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071250
Company: IMPAX LABS INC

Products on ANDA 071250

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071250

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/03/1988	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
07/16/2019	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
03/05/2012	SUPPL-34	REMS-Modified, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/29/2010	SUPPL-31	REMS-Proposal		Label is not available on this site.
05/23/2002	SUPPL-15	Labeling		Label is not available on this site.
05/29/2001	SUPPL-14	Manufacturing (CMC)-Facility		Label is not available on this site.
04/18/2001	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
02/05/2001	SUPPL-12	Labeling		Label is not available on this site.
07/07/2000	SUPPL-11	Manufacturing (CMC)-Facility		Label is not available on this site.
09/11/2000	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
11/24/1999	SUPPL-9	Labeling		Label is not available on this site.
06/27/2000	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/21/1995	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/19/1995	SUPPL-6	Labeling		Label is not available on this site.
11/03/1994	SUPPL-5	Labeling		Label is not available on this site.
05/11/1994	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/30/1992	SUPPL-3	Labeling		Label is not available on this site.
07/02/1991	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 071250

METOCLOPRAMIDE HYDROCHLORIDE

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	071250	IMPAX LABS INC
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078807	IPCA LABS LTD
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	070581	STRIDES PHARMA
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	077878	STRIDES PHARMA
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	070184	TEVA
REGLAN	METOCLOPRAMIDE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Prescription	Yes	AB	017854	ANI PHARMS

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	071250	IMPAX LABS INC
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	078807	IPCA LABS LTD
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	077878	STRIDES PHARMA
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	No	AB	072801	TEVA
REGLAN	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE	TABLET;ORAL	Prescription	Yes	AB	017854	ANI PHARMS