Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073135
Company: TEVA PHARMS USA
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
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
09/19/2013 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

06/03/2010 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

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.

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 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

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