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FDA ANDA · ANDA076217

AMIODARONE HYDROCHLORIDE

Sponsor: MYLAN INSTITUTIONAL

APPLICATION
ANDA076217
TYPE
ANDA
ORIGINAL APPROVAL
2002-10-15
LATEST ACTION
2020-06-23
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2020-06-23Labeling · Supplement 33 · standardAP
2009-06-24Labeling · Supplement 17AP
2008-03-24Labeling · Supplement 13AP
2007-10-15Labeling · Supplement 12AP
2006-02-01Labeling · Supplement 11AP
2004-01-05Labeling · Supplement 5AP
2003-11-14Labeling · Supplement 3AP
2002-10-15Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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