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FDA ANDA · ANDA076336

MIRTAZAPINE

Sponsor: ACTAVIS LABS FL INC

APPLICATION
ANDA076336
TYPE
ANDA
ORIGINAL APPROVAL
2003-06-20
LATEST ACTION
2007-11-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MIRTAZAPINEDiscontinued
MIRTAZAPINE 30MG · TABLET · ORAL
MIRTAZAPINEDiscontinued
MIRTAZAPINE 45MG · TABLET · ORAL
MIRTAZAPINEDiscontinued
MIRTAZAPINE 15MG · TABLET · ORAL

Approval history

2007-11-05Labeling · Supplement 7AP
2006-11-06Labeling · Supplement 6AP
2005-04-28Labeling · Supplement 5AP
2005-04-28Labeling · Supplement 3AP
2003-06-20OriginalOther Important Information from FDAAP
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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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