← FDA DRUG APPROVALS

FDA NDA · NDA020859

SONATA

Sponsor: PFIZER

APPLICATION
NDA020859
TYPE
NDA
ORIGINAL APPROVAL
1999-08-13
LATEST ACTION
2019-08-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

SONATA · ReferenceDiscontinued
ZALEPLON 5MG · CAPSULE · ORAL
SONATA · ReferenceDiscontinued
ZALEPLON 10MG · CAPSULE · ORAL

Approval history

2019-08-18Labeling · Supplement 16 · standard — Letter ↗AP
2019-02-06Labeling · Supplement 15 · 901 required — Label ↗AP
2013-04-19Labeling · Supplement 13 · standard — Label ↗AP
2012-11-21Manufacturing (CMC) · Supplement 14 · standardAP
2009-06-17Manufacturing (CMC) · Supplement 12AP
2007-12-11Labeling · Supplement 11 · standard — Label ↗AP
2007-12-11Labeling · Supplement 9 · standard — Letter ↗AP
2003-05-19Labeling · Supplement 4 · standard — Letter ↗AP
2003-05-19Labeling · Supplement 5 · standard — Letter ↗AP
2002-05-31Labeling · Supplement 2 · standard — Letter ↗AP
2002-05-31Labeling · Supplement 3 · standard — Letter ↗AP
2001-02-22Efficacy · Supplement 1 · standard — Letter ↗AP
1999-08-13Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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