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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078807
Company: IPCA LABS LTD

Products on ANDA 078807

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 078807

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2008	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
08/01/2025	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
08/01/2025	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/05/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/08/2012	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
02/21/2012	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/31/2010	SUPPL-3	Labeling-Medication Guide, REMS-Modified		Label is not available on this site.
12/01/2009	SUPPL-2	Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 078807

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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