APPLICATION
ANDA040058
TYPE
ANDA
ORIGINAL APPROVAL
1993-11-24
LATEST ACTION
2025-01-22
ROUTE
RECTAL
DOSAGE FORM
SUPPOSITORY
MARKETING STATUS
Prescription
Products
PROCHLORPERAZINEPrescription
PROCHLORPERAZINE 25MG · SUPPOSITORY · RECTAL
Approval history
2025-01-22Labeling · Supplement 26 · standardAP
2017-02-23Labeling · Supplement 21 · standardAP
2011-10-21Labeling · Supplement 15AP
2010-12-03Labeling · Supplement 14AP
2010-07-30Labeling · Supplement 13AP
2009-06-29Labeling · Supplement 11AP
2008-09-11Labeling · Supplement 10AP
2008-09-03Labeling · Supplement 8AP
2004-06-18Labeling · Supplement 6AP
1999-11-29Manufacturing (CMC) · Supplement 2AP
1997-04-07Manufacturing (CMC) · Supplement 1AP
1993-11-24OriginalAP
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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