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FDA ANDA · ANDA076276

LEVOFLOXACIN

Sponsor: NATCO PHARMA

APPLICATION
ANDA076276
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-20
LATEST ACTION
2024-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LEVOFLOXACINDiscontinued
LEVOFLOXACIN 500MG · TABLET · ORAL
LEVOFLOXACINDiscontinued
LEVOFLOXACIN 250MG · TABLET · ORAL

Approval history

2024-09-20Labeling · Supplement 11 · standardAP
2024-08-28Labeling · Supplement 10 · standardAP
2019-05-03Labeling · Supplement 8 · standardAP
2019-04-26Labeling · Supplement 7 · standardAP
2019-04-26Labeling · Supplement 5 · standardAP
2019-04-26Labeling · Supplement 6 · standardAP
2014-09-19Labeling · Supplement 4 · standardAP
2012-03-28Labeling · Supplement 2AP
2011-10-20Labeling · Supplement 1AP
2011-06-20OriginalLetterAP
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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