← FDA DRUG APPROVALS

FDA NDA · NDA018101

SYMMETREL

Sponsor: ENDO PHARMS

APPLICATION
NDA018101
TYPE
NDA
ORIGINAL APPROVAL
1980-11-03
LATEST ACTION
2009-02-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SYMMETREL · ReferenceDiscontinued
AMANTADINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2009-02-02Labeling · Supplement 16 · standard — Letter ↗AP
2008-09-24Labeling · Supplement 15 · standard — Letter ↗AP
2007-03-02Labeling · Supplement 14 · standard — Letter ↗AP
2003-11-18Labeling · Supplement 9 · standard — Review ↗AP
2000-12-06Labeling · Supplement 7 · standardAP
1999-03-12Manufacturing (CMC) · Supplement 5 · standardAP
1998-08-20Manufacturing (CMC) · Supplement 4 · standardAP
1998-01-23Manufacturing (CMC) · Supplement 3 · standardAP
1993-04-19Efficacy · Supplement 2 · standardAP
1980-11-03Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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