APPLICATION
ANDA071293
TYPE
ANDA
ORIGINAL APPROVAL
1987-02-18
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 44 · standardAP
2019-09-11Labeling · Supplement 38 · standardAP
2019-09-11Manufacturing (CMC) · Supplement 40 · unknownAP
2009-03-25Labeling · Supplement 31AP
2008-11-20Labeling · Supplement 29AP
2008-04-01Labeling · Supplement 28AP
2004-05-11Labeling · Supplement 21AP
2002-11-08Manufacturing (CMC) · Supplement 17AP
2002-11-08Manufacturing (CMC) · Supplement 18AP
2002-11-08Manufacturing (CMC) · Supplement 20AP
2002-11-08Manufacturing (CMC) · Supplement 19AP
2002-02-07Manufacturing (CMC) · Supplement 15AP
2002-02-07Manufacturing (CMC) · Supplement 16AP
1997-10-17Manufacturing (CMC) · Supplement 14AP
1997-01-07Manufacturing (CMC) · Supplement 12AP
1996-01-25Manufacturing (CMC) · Supplement 11AP
1996-01-25Manufacturing (CMC) · Supplement 9AP
1996-01-25Labeling · Supplement 7AP
1996-01-25Manufacturing (CMC) · Supplement 10AP
1996-01-25Manufacturing (CMC) · Supplement 8AP
1996-01-25Manufacturing (CMC) · Supplement 6AP
1994-09-28Labeling · Supplement 5AP
1991-09-11Labeling · Supplement 4AP
1991-06-27Manufacturing (CMC) · Supplement 3AP
1989-07-14Labeling · Supplement 2AP
1988-03-30Manufacturing (CMC) · Supplement 1AP
1987-02-18OriginalAP
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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