← FDA DRUG APPROVALS

FDA ANDA · ANDA074545

DOBUTAMINE HYDROCHLORIDE

Sponsor: LUITPOLD

APPLICATION
ANDA074545
TYPE
ANDA
ORIGINAL APPROVAL
1998-06-25
LATEST ACTION
2002-01-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DOBUTAMINE HYDROCHLORIDEDiscontinued
DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML · INJECTABLE · INJECTION

Approval history

2002-01-30Labeling · Supplement 1AP
1998-06-25OriginalLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →