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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074277
Company: HIKMA

Products on ANDA 074277

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074277

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
03/06/2024	SUPPL-21	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 074277

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

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