APPLICATION
ANDA090453
TYPE
ANDA
ORIGINAL APPROVAL
2015-03-20
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MOLINDONE HYDROCHLORIDEPrescription
MOLINDONE HYDROCHLORIDE 25MG · TABLET · ORAL
MOLINDONE HYDROCHLORIDEPrescription
MOLINDONE HYDROCHLORIDE 5MG · TABLET · ORAL
MOLINDONE HYDROCHLORIDEPrescription
MOLINDONE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 11 · standardAP
2017-02-23Labeling · Supplement 4 · standardAP
2015-03-20OriginalAP
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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