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FDA ANDA · ANDA081306

ETHOSUXIMIDE

Sponsor: TEVA PHARMS

APPLICATION
ANDA081306
TYPE
ANDA
ORIGINAL APPROVAL
1993-07-30
LATEST ACTION
2010-06-29
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

ETHOSUXIMIDEDiscontinued
ETHOSUXIMIDE 250MG/5ML · SYRUP · ORAL

Approval history

2010-06-29Labeling · Supplement 17AP
2002-09-27Labeling · Supplement 14AP
2002-04-08Labeling · Supplement 13AP
2002-01-23Manufacturing (CMC) · Supplement 7AP
2001-10-31Manufacturing (CMC) · Supplement 8AP
2001-10-31Manufacturing (CMC) · Supplement 10AP
2001-10-31Manufacturing (CMC) · Supplement 9AP
2001-02-26Manufacturing (CMC) · Supplement 6AP
1999-09-20Manufacturing (CMC) · Supplement 5AP
1999-03-23Manufacturing (CMC) · Supplement 4AP
1998-10-29Manufacturing (CMC) · Supplement 3AP
1996-05-31Manufacturing (CMC) · Supplement 2AP
1994-01-21Manufacturing (CMC) · Supplement 1AP
1993-07-30OriginalAP
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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