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FDA ANDA · ANDA091563

DISULFIRAM

Sponsor: CHARTWELL MOLECULES

APPLICATION
ANDA091563
TYPE
ANDA
ORIGINAL APPROVAL
2012-12-31
LATEST ACTION
2021-11-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DISULFIRAMPrescription
DISULFIRAM 500MG · TABLET · ORAL
DISULFIRAMPrescription
DISULFIRAM 250MG · TABLET · ORAL

Approval history

2021-11-02Manufacturing (CMC) · Supplement 7AP
2012-12-31OriginalAP
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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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