APPLICATION
NDA016023
TYPE
NDA
ORIGINAL APPROVAL
1968-02-14
LATEST ACTION
2009-02-02
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
SYMMETREL · ReferenceDiscontinued
AMANTADINE HYDROCHLORIDE 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL
Approval history
2002-01-11Manufacturing (CMC) · Supplement 36 · priorityAP
2000-12-06Labeling · Supplement 35 · priorityAP
1999-06-08Manufacturing (CMC) · Supplement 33 · priorityAP
1996-01-05Manufacturing (CMC) · Supplement 31 · priorityAP
1993-04-19Efficacy · Supplement 23 · priorityAP
1992-08-11Manufacturing (CMC) · Supplement 30 · priorityAP
1992-02-06Manufacturing (CMC) · Supplement 26 · priorityAP
1992-02-04Manufacturing (CMC) · Supplement 27 · priorityAP
1989-10-23Labeling · Supplement 24 · priorityAP
1987-01-16Efficacy · Supplement 22 · priorityAP
1986-02-14Labeling · Supplement 21 · priorityAP
1985-01-04Manufacturing (CMC) · Supplement 20 · priorityAP
1982-12-08Manufacturing (CMC) · Supplement 19 · priorityAP
1977-11-16Manufacturing (CMC) · Supplement 15 · priorityAP
1977-08-10Manufacturing (CMC) · Supplement 16 · priorityAP
1976-01-07Manufacturing (CMC) · Supplement 14 · priorityAP
1968-02-14Type 3 - New Dosage Form · Original · priorityAP
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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