APPLICATION
ANDA085385
TYPE
ANDA
ORIGINAL APPROVAL
1977-03-03
LATEST ACTION
1977-03-03
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
PROMETHAZINE HYDROCHLORIDEDiscontinued
PROMETHAZINE HYDROCHLORIDE 25MG/5ML · SYRUP · ORAL
Approval history
1977-03-03OriginalAP
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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