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FDA ANDA · ANDA040027
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
Sponsor: HIKMA
APPLICATION
ANDA040027
TYPE
ANDA
ORIGINAL APPROVAL
1996-07-31
LATEST ACTION
2005-12-21
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEDiscontinued
DEXTROMETHORPHAN HYDROBROMIDE 15MG/5ML, PROMETHAZINE HYDROCHLORIDE 6.25MG/5ML · SYRUP · ORAL
Approval history
2005-12-21Labeling · Supplement 3AP
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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