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FDA ANDA · ANDA074895

AMIODARONE HYDROCHLORIDE

Sponsor: TEVA

APPLICATION
ANDA074895
TYPE
ANDA
ORIGINAL APPROVAL
1999-04-16
LATEST ACTION
2000-07-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMIODARONE HYDROCHLORIDEDiscontinued
AMIODARONE HYDROCHLORIDE 200MG · TABLET · ORAL

Approval history

2000-07-26Labeling · Supplement 5AP
2000-07-26Manufacturing (CMC) · Supplement 4AP
2000-07-26Manufacturing (CMC) · Supplement 7AP
2000-06-29Manufacturing (CMC) · Supplement 3AP
2000-02-11Labeling · Supplement 2AP
1999-04-16Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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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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