APPLICATION
ANDA080983
TYPE
ANDA
ORIGINAL APPROVAL
1976-03-01
LATEST ACTION
2026-04-14
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription
Products
SONAZINEPrescription
CHLORPROMAZINE HYDROCHLORIDE 30MG/ML · CONCENTRATE · ORAL
SONAZINEPrescription
CHLORPROMAZINE HYDROCHLORIDE 100MG/ML · CONCENTRATE · ORAL
Approval history
2026-04-14Labeling · Supplement 63 · standardAP
2025-02-26Manufacturing (CMC) · Supplement 62 · unknownAP
2020-02-05Labeling · Supplement 61 · standardAP
2017-02-23Labeling · Supplement 60 · standardAP
2015-08-12Labeling · Supplement 59AP
1994-01-24Manufacturing (CMC) · Supplement 54AP
1992-06-04Labeling · Supplement 53AP
1990-02-16Labeling · Supplement 48AP
1988-05-19Labeling · Supplement 45AP
1986-05-29Manufacturing (CMC) · Supplement 42AP
1985-02-08Manufacturing (CMC) · Supplement 40AP
1984-09-18Manufacturing (CMC) · Supplement 38AP
1983-07-12Manufacturing (CMC) · Supplement 35AP
1983-06-07Manufacturing (CMC) · Supplement 36AP
1983-05-18Manufacturing (CMC) · Supplement 34AP
1982-12-03Manufacturing (CMC) · Supplement 32AP
1976-03-01OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.