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FDA ANDA · ANDA075955

AMIODARONE HYDROCHLORIDE

Sponsor: HOSPIRA

APPLICATION
ANDA075955
TYPE
ANDA
ORIGINAL APPROVAL
2002-10-18
LATEST ACTION
2013-08-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

AMIODARONE HYDROCHLORIDEDiscontinued
AMIODARONE HYDROCHLORIDE 50MG/ML · INJECTABLE · INJECTION

Approval history

2013-08-16Labeling · Supplement 15 · standard — Label ↗AP
2010-06-30Labeling · Supplement 12AP
2007-09-12Labeling · Supplement 9AP
2006-06-27Labeling · Supplement 6AP
2002-10-18Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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.

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