APPLICATION
ANDA091482
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-23
LATEST ACTION
2024-02-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
FLUVOXAMINE MALEATEPrescription
FLUVOXAMINE MALEATE 150MG · CAPSULE, EXTENDED RELEASE · ORAL
FLUVOXAMINE MALEATEPrescription
FLUVOXAMINE MALEATE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-02-12Labeling · Supplement 12 · standardAP
2023-08-18Labeling · Supplement 11 · standardAP
2023-08-10Labeling · Supplement 10 · standardAP
2020-11-13Labeling · Supplement 7 · standardAP
2020-11-13Labeling · Supplement 3 · standardAP
2013-11-18OriginalAP
2013-04-23OriginalAP
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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