APPLICATION
ANDA076698
TYPE
ANDA
ORIGINAL APPROVAL
2003-12-23
LATEST ACTION
2004-10-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METOLAZONEPrescription
METOLAZONE 5MG · TABLET · ORAL
METOLAZONEPrescription
METOLAZONE 10MG · TABLET · ORAL
METOLAZONEPrescription
METOLAZONE 2.5MG · TABLET · ORAL
Approval history
2004-10-19Supplement · Supplement 3AP
2004-10-19Supplement · Supplement 1AP
2004-10-19Labeling · Supplement 4AP
2004-10-19Labeling · Supplement 2AP
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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