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FDA ANDA · ANDA209469

MOXIFLOXACIN OPHTHALMIC SOLUTION

Sponsor: ALEMBIC

APPLICATION
ANDA209469
TYPE
ANDA
ORIGINAL APPROVAL
2019-02-13
LATEST ACTION
2021-07-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

MOXIFLOXACIN HYDROCHLORIDEPrescription
MOXIFLOXACIN HYDROCHLORIDE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2021-07-19Labeling · Supplement 2 · standardAP
2021-07-19Labeling · Supplement 1 · standardAP
2019-02-13UNKNOWN · Original · standardAP
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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