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FDA ANDA · ANDA202632

MOXIFLOXACIN HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA202632
TYPE
ANDA
ORIGINAL APPROVAL
2014-03-04
LATEST ACTION
2019-12-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MOXIFLOXACIN HYDROCHLORIDEPrescription
MOXIFLOXACIN HYDROCHLORIDE EQ 400MG BASE · TABLET · ORAL

Approval history

2019-12-05Labeling · Supplement 13 · standardAP
2019-12-05Labeling · Supplement 7 · standardAP
2019-12-05Labeling · Supplement 5 · standardAP
2019-12-05Labeling · Supplement 14 · standardAP
2019-12-05Labeling · Supplement 10 · standardAP
2019-12-05Labeling · Supplement 6 · standardAP
2019-12-05Labeling · Supplement 4 · standardAP
2015-03-20Labeling · Supplement 1 · standardAP
2014-03-04UNKNOWN · Original — Letter ↗AP
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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