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FDA ANDA · ANDA214238

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Sponsor: QUAGEN

APPLICATION
ANDA214238
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-08
LATEST ACTION
2025-12-22
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

2025-12-22Labeling · Supplement 3 · standardAP
2023-12-15Labeling · Supplement 1 · standardAP
2020-10-08UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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