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FDA NDA · NDA017118

SYMMETREL

Sponsor: ENDO PHARMS

APPLICATION
NDA017118
TYPE
NDA
ORIGINAL APPROVAL
1976-07-20
LATEST ACTION
2008-12-31
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

SYMMETRELDiscontinued
AMANTADINE HYDROCHLORIDE 50MG/5ML · SYRUP · ORAL

Approval history

2008-12-31Labeling · Supplement 19 · priority — Letter ↗AP
2003-09-04Labeling · Supplement 17 · priority — Label ↗AP
2002-01-11Manufacturing (CMC) · Supplement 16 · priorityAP
1999-06-29Manufacturing (CMC) · Supplement 13 · priorityAP
1999-03-31Manufacturing (CMC) · Supplement 12 · priorityAP
1996-04-11Manufacturing (CMC) · Supplement 10 · priorityAP
1986-03-03Labeling · Supplement 7 · priorityAP
1978-10-27Manufacturing (CMC) · Supplement 2 · priorityAP
1977-09-02Labeling · Supplement 1 · priorityAP
1976-07-20Type 6 - New Indication (no longer used) · Original · priorityAP
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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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