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Drugs@FDA: FDA-Approved Drugs

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

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 074277 HIKMA
DOBUTAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074086 HOSPIRA
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