APPLICATION
ANDA074509
TYPE
ANDA
ORIGINAL APPROVAL
1995-07-17
LATEST ACTION
2025-07-10
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
AMANTADINE HYDROCHLORIDEPrescription
AMANTADINE HYDROCHLORIDE 50MG/5ML · SYRUP · ORAL
Approval history
2025-07-10Labeling · Supplement 19 · standardAP
2012-06-05Labeling · Supplement 12AP
2011-09-26Labeling · Supplement 11AP
2009-12-07Labeling · Supplement 10AP
2009-04-29Labeling · Supplement 9AP
2009-02-19Labeling · Supplement 8AP
2008-09-03Labeling · Supplement 7AP
2007-09-14Labeling · Supplement 6AP
2006-05-01Labeling · Supplement 4AP
2002-09-18Labeling · Supplement 3AP
1999-07-20Manufacturing (CMC) · Supplement 1AP
1999-07-20Manufacturing (CMC) · Supplement 2AP
1995-07-17OriginalAP
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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