APPLICATION
ANDA074028
TYPE
ANDA
ORIGINAL APPROVAL
1993-06-28
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 18 · standardAP
2012-01-18Labeling · Supplement 17AP
2006-03-22Labeling · Supplement 12AP
2002-08-13Manufacturing (CMC) · Supplement 9AP
1998-07-31Manufacturing (CMC) · Supplement 8AP
1998-02-04Manufacturing (CMC) · Supplement 7AP
1998-02-04Manufacturing (CMC) · Supplement 6AP
1997-09-12Manufacturing (CMC) · Supplement 5AP
1996-01-25Manufacturing (CMC) · Supplement 3AP
1995-12-22Labeling · Supplement 4AP
1995-06-12Manufacturing (CMC) · Supplement 2AP
1994-09-27Labeling · Supplement 1AP
1993-06-28OriginalAP
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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