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FDA ANDA · ANDA076312

MIRTAZAPINE

Sponsor: WATSON LABS

APPLICATION
ANDA076312
TYPE
ANDA
ORIGINAL APPROVAL
2003-06-19
LATEST ACTION
2014-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2014-10-24Labeling · Supplement 9 · standardAP
2014-10-23Labeling · Supplement 11 · standardAP
2008-12-02Labeling · Supplement 7AP
2008-06-03Labeling · Supplement 6AP
2007-11-06Labeling · Supplement 5AP
2007-01-29Labeling · Supplement 4AP
2005-08-23Labeling · Supplement 3AP
2005-01-21Labeling · Supplement 1AP
2003-06-19Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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