APPLICATION
ANDA074884
TYPE
ANDA
ORIGINAL APPROVAL
1997-12-17
LATEST ACTION
2002-05-31
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
CLEMASTINE FUMARATEPrescription
CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML · SYRUP · ORAL
Approval history
2002-05-31Labeling · Supplement 2AP
2002-05-31Manufacturing (CMC) · Supplement 1AP
1997-12-17OriginalAP
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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