APPLICATION
ANDA212182
TYPE
ANDA
ORIGINAL APPROVAL
2020-05-11
LATEST ACTION
2023-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
FLUVOXAMINE MALEATEPrescription
FLUVOXAMINE MALEATE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
FLUVOXAMINE MALEATEPrescription
FLUVOXAMINE MALEATE 150MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2023-11-21Labeling · Supplement 6 · standardAP
2023-08-18Labeling · Supplement 5 · standardAP
2020-05-11UNKNOWN · Original · standardAP
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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