APPLICATION
ANDA040650
TYPE
ANDA
ORIGINAL APPROVAL
2006-01-31
LATEST ACTION
2025-12-23
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
PROMETHAZINE WITH CODEINEDiscontinued
CODEINE PHOSPHATE 10MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL
Approval history
2025-12-23Labeling · Supplement 31 · standardAP
2025-12-22Labeling · Supplement 30 · standardAP
2023-12-15Labeling · Supplement 29 · standardAP
2018-06-28Labeling · Supplement 25 · standardAP
2018-06-19Labeling · Supplement 22 · standardAP
2017-08-29Labeling · Supplement 19 · standardAP
2017-08-29Labeling · Supplement 21 · standardAP
2017-01-13Labeling · Supplement 17 · standardAP
2013-05-10Labeling · Supplement 13 · standardAP
2009-09-08Labeling · Supplement 6AP
2008-12-19Labeling · Supplement 3AP
2008-02-25Labeling · Supplement 2AP
2006-01-31OriginalAP
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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