Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074086
Company: HOSPIRA

Products on ANDA 074086

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DOBUTAMINE HYDROCHLORIDE	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074086

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/1993	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
12/31/2002	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
10/23/1997	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/07/1997	SUPPL-5	Labeling		Label is not available on this site.
12/02/1996	SUPPL-4	Labeling		Label is not available on this site.
10/03/1996	SUPPL-3	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/07/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074086

DOBUTAMINE HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 12.5MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DOBUTAMINE HYDROCHLORIDE	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	216131	HAINAN POLY
DOBUTAMINE HYDROCHLORIDE	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	074277	HIKMA
DOBUTAMINE HYDROCHLORIDE	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	074086	HOSPIRA