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FDA ANDA · ANDA089647
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
Sponsor: PHARM ASSOC
APPLICATION
ANDA089647
TYPE
ANDA
ORIGINAL APPROVAL
1988-12-22
LATEST ACTION
2023-12-15
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
2023-12-15Labeling · Supplement 17 · standardAP
2018-06-28Labeling · Supplement 16 · standardAP
2018-06-19Labeling · Supplement 14 · standardAP
2018-06-19Labeling · Supplement 15 · standardAP
2017-08-29Labeling · Supplement 12 · standardAP
2017-08-29Labeling · Supplement 13 · standardAP
2017-01-13Labeling · Supplement 11 · standardAP
2013-05-10Labeling · Supplement 10 · standardAP
2010-01-21Labeling · Supplement 7AP
2009-01-23Labeling · Supplement 6AP
2008-12-19Labeling · Supplement 5AP
2004-12-17Labeling · Supplement 3AP
1988-12-22OriginalAP
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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