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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077878
Company: STRIDES PHARMA INTL

Products on ANDA 077878

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077878

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/28/2006	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-12	Labeling-Package Insert		Label is not available on this site.
08/13/2012	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/28/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/30/2010	SUPPL-3	Labeling-Medication Guide		Label is not available on this site.
04/30/2010	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077878

METOCLOPRAMIDE HYDROCHLORIDE

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	072215	AIPING PHARM 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 INTL
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

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	072215	AIPING PHARM 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	077878	STRIDES PHARMA INTL
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

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