Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 073118
Company: HOSPIRA

Products on ANDA 073118

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073118

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.

Therapeutic Equivalents for ANDA 073118

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