Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073118
Company: HOSPIRA
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/17/1991 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
06/02/2015 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

06/02/2015 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/03/2006 SUPPL-18 Labeling

Label is not available on this site.

05/05/2003 SUPPL-16 Labeling

Label is not available on this site.

12/09/2002 SUPPL-15 Labeling

Label is not available on this site.

10/25/2002 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/01/2002 SUPPL-13 Labeling

Label is not available on this site.

03/22/2001 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/13/1999 SUPPL-10 Labeling

Label is not available on this site.

01/07/2000 SUPPL-9 Labeling

Label is not available on this site.

01/07/2000 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/25/1997 SUPPL-7 Labeling

Label is not available on this site.

10/03/1996 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/22/1996 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/30/1995 SUPPL-2 Labeling

Label is not available on this site.

02/07/1996 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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