← FDA DRUG APPROVALS

FDA NDA · NDA018708

QUAZEPAM

Sponsor: GALT PHARMS

APPLICATION
NDA018708
TYPE
NDA
ORIGINAL APPROVAL
1985-12-27
LATEST ACTION
2023-01-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

DORALDiscontinued
QUAZEPAM 7.5MG · TABLET · ORAL
DORAL · ReferencePrescription
QUAZEPAM 15MG · TABLET · ORAL

Approval history

2023-01-13Labeling · Supplement 29 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 27 · 901 required — Letter ↗AP
2019-02-06Labeling · Supplement 25 · 901 required — Label ↗AP
2016-12-16Labeling · Supplement 23 · 901 required — Label ↗AP
2013-04-19Manufacturing (CMC) · Supplement 21 · standard — Label ↗AP
2013-04-19Labeling · Supplement 20 · unknown — Label ↗AP
2010-04-13Labeling · Supplement 18 · standard — Label ↗AP
2007-10-30Labeling · Supplement 17 · standard — Letter ↗AP
2002-11-14Labeling · Supplement 14 · standard — Letter ↗AP
1996-09-12Manufacturing (CMC) · Supplement 13 · standardAP
1994-02-03Manufacturing (CMC) · Supplement 12 · standardAP
1993-11-12Manufacturing (CMC) · Supplement 10 · standardAP
1991-08-05Manufacturing (CMC) · Supplement 6 · standardAP
1991-07-11Manufacturing (CMC) · Supplement 9 · standardAP
1991-02-08Manufacturing (CMC) · Supplement 7 · standardAP
1991-02-08Manufacturing (CMC) · Supplement 5 · standardAP
1987-02-26Manufacturing (CMC) · Supplement 2 · standardAP
1987-02-26Manufacturing (CMC) · Supplement 3 · standardAP
1987-02-26Labeling · Supplement 1AP
1985-12-27Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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