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FDA ANDA · ANDA040151
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Sponsor: HIKMA
APPLICATION
ANDA040151
TYPE
ANDA
ORIGINAL APPROVAL
1997-08-26
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEDiscontinued
CODEINE PHOSPHATE 10MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL
Approval history
2025-12-22Labeling · Supplement 28 · standardAP
2023-12-15Labeling · Supplement 26 · standardAP
2018-06-28Labeling · Supplement 20 · standardAP
2018-06-19Labeling · Supplement 19 · standardAP
2017-08-29Labeling · Supplement 16 · standardAP
2017-08-29Labeling · Supplement 18 · standardAP
2017-01-13Labeling · Supplement 15 · standardAP
2013-05-10Labeling · Supplement 13 · standardAP
2010-04-26Labeling · Supplement 9AP
2009-10-09Labeling · Supplement 8AP
2009-10-09Labeling · Supplement 29AP
2008-12-19Labeling · Supplement 7AP
2008-02-25Labeling · Supplement 6AP
2008-02-04Labeling · Supplement 3AP
2006-02-17Labeling · Supplement 2AP
1997-08-26OriginalAP
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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