FDA ANDA · ANDA079107

LEVETIRACETAM

Sponsor: TOLMAR

APPLICATION

ANDA079107

TYPE

ANDA

ORIGINAL APPROVAL

2009-01-15

LATEST ACTION

2014-11-03

ROUTE

ORAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

LEVETIRACETAMDiscontinued

LEVETIRACETAM 100MG/ML · SOLUTION · ORAL

2014-11-03Labeling · Supplement 18 · standardAP

2014-11-03Labeling · Supplement 12 · standardAP

2014-11-03Labeling · Supplement 10AP

2014-11-03Labeling · Supplement 15 · standardAP

2012-10-26Labeling · Supplement 11 · standardAP

2010-12-29Labeling · Supplement 7AP

2009-08-20Labeling · Supplement 3AP

2009-01-15Original — Letter ↗AP

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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