← FDA DRUG APPROVALS
FDA ANDA · ANDA088875
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Sponsor: PHARMOBEDIENT
APPLICATION
ANDA088875
TYPE
ANDA
ORIGINAL APPROVAL
1984-12-17
LATEST ACTION
2025-12-29
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEPrescription
CODEINE PHOSPHATE 10MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL
Approval history
2025-12-29Labeling · Supplement 48 · standardAP
2025-12-15Labeling · Supplement 47 · standardAP
2018-06-28Labeling · Supplement 39 · standardAP
2017-11-17Labeling · Supplement 38 · standardAP
2017-01-13Labeling · Supplement 37 · standardAP
2015-10-29Manufacturing (CMC) · Supplement 34 · unknownAP
2013-05-10Labeling · Supplement 35 · standardAP
2010-01-21Labeling · Supplement 32AP
2008-12-19Labeling · Supplement 31AP
2008-02-25Labeling · Supplement 30AP
2006-04-03Labeling · Supplement 29AP
2002-06-27Manufacturing (CMC) · Supplement 25AP
2002-06-27Labeling · Supplement 26AP
2002-06-27Manufacturing (CMC) · Supplement 24AP
1991-01-18Labeling · Supplement 17AP
1990-08-23Labeling · Supplement 16AP
1990-01-31Labeling · Supplement 15AP
1989-04-05Manufacturing (CMC) · Supplement 14AP
1988-08-08Manufacturing (CMC) · Supplement 13AP
1987-04-07Manufacturing (CMC) · Supplement 7AP
1987-04-07Manufacturing (CMC) · Supplement 5AP
1987-04-07Manufacturing (CMC) · Supplement 8AP
1987-04-07Manufacturing (CMC) · Supplement 6AP
1987-04-07Manufacturing (CMC) · Supplement 4AP
1986-03-05Manufacturing (CMC) · Supplement 1AP
1986-03-05Manufacturing (CMC) · Supplement 2AP
1984-12-17OriginalAP
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.