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FDA NDA · NDA020989

EVOXAC

cevimeline hydrochloride

Sponsor: COSETTE

APPLICATION
NDA020989
TYPE
NDA
ORIGINAL APPROVAL
2000-01-11
LATEST ACTION
2013-11-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

EVOXAC · ReferencePrescription
CEVIMELINE HYDROCHLORIDE 30MG · CAPSULE · ORAL

Approval history

2013-11-01Manufacturing (CMC) · Supplement 12 · standardAP
2006-12-08Labeling · Supplement 8 · standard — Letter ↗AP
2005-12-13Labeling · Supplement 6 · standard — Letter ↗AP
2002-01-04Manufacturing (CMC) · Supplement 5 · standardAP
2001-02-09Manufacturing (CMC) · Supplement 3 · standardAP
2001-01-31Manufacturing (CMC) · Supplement 2 · standardAP
2000-12-19Manufacturing (CMC) · Supplement 1 · standardAP
2000-01-11Type 1 - New Molecular Entity · Original · standard — Review ↗AP
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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