Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073135
Company: TEVA PHARMS USA

Products on ANDA 073135

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073135

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/27/1991	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
03/06/2024	SUPPL-28	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/06/2024	SUPPL-25	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/19/2013	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
06/03/2010	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/19/2004	SUPPL-7	Labeling		Label is not available on this site.
08/22/2002	SUPPL-5	Labeling		Label is not available on this site.
11/24/1999	SUPPL-4	Labeling		Label is not available on this site.
03/06/1996	SUPPL-3	Labeling		Label is not available on this site.
06/02/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/10/1993	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 073135

METOCLOPRAMIDE HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 5MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METOCLOPRAMIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	204756	AVET LIFESCIENCES
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	091392	FRESENIUS KABI USA
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	073118	HOSPIRA
METOCLOPRAMIDE HYDROCHLORIDE	METOCLOPRAMIDE HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	073135	TEVA PHARMS USA