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FDA ANDA · ANDA080258

ZARONTIN

ethosuximide

Sponsor: PARKE-DAVIS

APPLICATION
ANDA080258
TYPE
ANDA
ORIGINAL APPROVAL
1974-02-13
LATEST ACTION
2021-10-29
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription

Products

ZARONTIN · ReferencePrescription
ETHOSUXIMIDE 250MG/5ML · SYRUP · ORAL

Approval history

2021-10-29Labeling · Supplement 35 · standardAP
2021-10-29Labeling · Supplement 32 · standardAP
2014-01-16Labeling · Supplement 29 · standard — Label ↗AP
2014-01-16Labeling · Supplement 31 · standard — Label ↗AP
2012-10-25REMS · Supplement 30AP
2011-04-25REMS · Supplement 28AP
2009-11-20Labeling · Supplement 27AP
2009-11-20Labeling · Supplement 26AP
2009-05-06Labeling · Supplement 25 — Label ↗AP
2006-10-03Labeling · Supplement 20AP
1998-10-27Manufacturing (CMC) · Supplement 16AP
1997-10-22Manufacturing (CMC) · Supplement 14AP
1996-03-13Manufacturing (CMC) · Supplement 13AP
1995-07-28Manufacturing (CMC) · Supplement 12AP
1974-02-13OriginalAP
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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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