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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072215
Company: AIPING PHARM INC

Products on ANDA 072215

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 072215

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/30/1990	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
12/13/1995	SUPPL-4	Labeling		Label is not available on this site.
10/21/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/24/1992	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/18/1990	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 072215

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	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

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

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