← FDA DRUG APPROVALS
FDA ANDA · ANDA200963
PROMETHAZINE AND PHENYLEPHRINE HCL, AND CODEINE PHOSPHATE
promethazine, phenylephrine, codeine
Sponsor: AMNEAL PHARMS
APPLICATION
ANDA200963
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-26
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATEPrescription
CODEINE PHOSPHATE 10MG/5ML, PHENYLEPHRINE HYDROCHLORIDE 5MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL
Approval history
2025-12-22Labeling · Supplement 12 · standardAP
2025-12-22Labeling · Supplement 13 · standardAP
2023-12-15Labeling · Supplement 11 · standardAP
2018-06-28Labeling · Supplement 5 · standardAP
2018-06-08Labeling · Supplement 3 · standardAP
2017-08-29Labeling · Supplement 2 · standardAP
2017-01-13Labeling · Supplement 1 · standardAP
2015-08-26Not Applicable · OriginalAP
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.