APPLICATION
ANDA040246
TYPE
ANDA
ORIGINAL APPROVAL
2000-06-28
LATEST ACTION
2025-01-22
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Prescription
Products
COMPROPrescription
PROCHLORPERAZINE 25MG · SUPPOSITORY · RECTAL
Approval history
2025-01-22Labeling · Supplement 18 · standardAP
2017-02-23Labeling · Supplement 14 · standardAP
2011-10-25Labeling · Supplement 13AP
2010-12-03Labeling · Supplement 12AP
2009-07-07Labeling · Supplement 8AP
2009-03-03Labeling · Supplement 7AP
2008-05-15Labeling · Supplement 6AP
2001-02-09Manufacturing (CMC) · Supplement 1AP
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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