APPLICATION
ANDA070589
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-07
LATEST ACTION
2025-07-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
AMANTADINE HYDROCHLORIDEPrescription
AMANTADINE HYDROCHLORIDE 100MG · CAPSULE · ORAL
Approval history
2025-07-10Labeling · Supplement 54 · standardAP
2014-07-28Manufacturing (CMC) · Supplement 44AP
2012-01-11Labeling · Supplement 45AP
2009-06-05Labeling · Supplement 40AP
2009-02-09Labeling · Supplement 38AP
2007-11-19Labeling · Supplement 37AP
2004-11-17Labeling · Supplement 29AP
2003-10-31Labeling · Supplement 26AP
2003-03-26Labeling · Supplement 24AP
1997-12-16Labeling · Supplement 21AP
1996-10-18Manufacturing (CMC) · Supplement 19AP
1996-10-18Manufacturing (CMC) · Supplement 17AP
1996-10-18Manufacturing (CMC) · Supplement 18AP
1996-10-18Manufacturing (CMC) · Supplement 16AP
1996-10-18Labeling · Supplement 20AP
1995-05-09Manufacturing (CMC) · Supplement 15AP
1995-05-09Manufacturing (CMC) · Supplement 14AP
1993-09-24Manufacturing (CMC) · Supplement 13AP
1993-09-24Manufacturing (CMC) · Supplement 9AP
1993-09-24Manufacturing (CMC) · Supplement 11AP
1993-09-24Manufacturing (CMC) · Supplement 12AP
1993-09-24Manufacturing (CMC) · Supplement 10AP
1991-10-16Labeling · Supplement 8AP
1991-02-26Labeling · Supplement 7AP
1991-02-26Labeling · Supplement 6AP
1989-03-27Manufacturing (CMC) · Supplement 5AP
1988-08-26Labeling · Supplement 4AP
1988-05-05Manufacturing (CMC) · Supplement 2AP
1987-01-07Manufacturing (CMC) · Supplement 1AP
1987-01-07OriginalAP
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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