APPLICATION
ANDA073115
TYPE
ANDA
ORIGINAL APPROVAL
1991-08-23
LATEST ACTION
1999-10-07
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
AMANTADINE HYDROCHLORIDEDiscontinued
AMANTADINE HYDROCHLORIDE 50MG/5ML · SYRUP · ORAL
Approval history
1999-10-07Manufacturing (CMC) · Supplement 7AP
1999-03-23Manufacturing (CMC) · Supplement 6AP
1998-11-16Manufacturing (CMC) · Supplement 5AP
1998-06-11Manufacturing (CMC) · Supplement 4AP
1997-09-30Manufacturing (CMC) · Supplement 3AP
1996-05-31Manufacturing (CMC) · Supplement 2AP
1993-12-03Labeling · Supplement 1AP
1991-08-23OriginalAP
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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