APPLICATION
ANDA213827
TYPE
ANDA
ORIGINAL APPROVAL
2021-03-30
LATEST ACTION
2026-01-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METOLAZONEPrescription
METOLAZONE 10MG · TABLET · ORAL
METOLAZONEPrescription
METOLAZONE 2.5MG · TABLET · ORAL
METOLAZONEPrescription
METOLAZONE 5MG · TABLET · ORAL
Approval history
2026-01-07Manufacturing (CMC) · Supplement 3 · unknownAP
2021-03-30UNKNOWN · 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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