Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074277
Company: WEST-WARD PHARMS INT
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 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
10/31/1994 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
11/07/2001 SUPPL-13 Labeling

Label is not available on this site.

04/03/2001 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/05/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1998 SUPPL-10 Labeling

Label is not available on this site.

12/22/1997 SUPPL-9 Labeling

Label is not available on this site.

08/28/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/26/1997 SUPPL-3 Labeling

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 074086 HOSPIRA
DOBUTAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074292 HOSPIRA
DOBUTAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE;INJECTION Prescription No AP 074277 WEST-WARD PHARMS INT

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