← FDA DRUG APPROVALS

FDA NDA · NDA018163

RESTORIL

temazepam

Sponsor: SPECGX LLC

APPLICATION
NDA018163
TYPE
NDA
ORIGINAL APPROVAL
1981-02-27
LATEST ACTION
2023-01-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

RESTORIL · ReferencePrescription
TEMAZEPAM 22.5MG · CAPSULE · ORAL
RESTORIL · ReferencePrescription
TEMAZEPAM 30MG · CAPSULE · ORAL
RESTORIL · ReferencePrescription
TEMAZEPAM 7.5MG · CAPSULE · ORAL
RESTORIL · ReferencePrescription
TEMAZEPAM 15MG · CAPSULE · ORAL

Approval history

2023-01-13Labeling · Supplement 71 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 67 · 901 required — Letter ↗AP
2019-02-06Labeling · Supplement 65 · 901 required — Label ↗AP
2016-12-16Labeling · Supplement 64 · 901 required — Label ↗AP
2010-11-08Labeling · Supplement 54 · standard — Label ↗AP
2008-02-25Labeling · Supplement 58 · standard — Letter ↗AP
2008-02-25Labeling · Supplement 59 · standard — Label ↗AP
2004-11-02Manufacturing (CMC) · Supplement 57 · standard — Letter ↗AP
2002-05-31Labeling · Supplement 53 · standard — Letter ↗AP
2000-04-11Labeling · Supplement 48 · standardAP
2000-04-11Labeling · Supplement 32AP
1999-10-27Manufacturing (CMC) · Supplement 52 · standardAP
1999-04-15Manufacturing (CMC) · Supplement 51 · standardAP
1995-12-18Manufacturing (CMC) · Supplement 49 · standardAP
1995-12-07Manufacturing (CMC) · Supplement 50 · standardAP
1995-02-27Manufacturing (CMC) · Supplement 46 · standardAP
1994-12-13Manufacturing (CMC) · Supplement 47 · standardAP
1994-07-19Labeling · Supplement 29AP
1994-07-15Manufacturing (CMC) · Supplement 43 · standardAP
1994-07-13Manufacturing (CMC) · Supplement 38 · standardAP
1994-07-13Manufacturing (CMC) · Supplement 39 · standardAP
1994-03-29Labeling · Supplement 31AP
1994-03-17Manufacturing (CMC) · Supplement 35 · standardAP
1994-02-28Manufacturing (CMC) · Supplement 30 · standardAP
1993-07-23Manufacturing (CMC) · Supplement 41 · standardAP
1993-06-15Manufacturing (CMC) · Supplement 45 · standardAP
1993-04-21Manufacturing (CMC) · Supplement 34 · standardAP
1993-02-02Labeling · Supplement 44 · standardAP
1992-11-25Labeling · Supplement 42 · standardAP
1992-08-10Labeling · Supplement 40AP
1992-04-16Labeling · Supplement 37AP
1992-04-15Manufacturing (CMC) · Supplement 36 · standardAP
1991-10-25Efficacy · Supplement 11AP
1991-10-25Efficacy · Supplement 22AP
1990-03-14Manufacturing (CMC) · Supplement 28 · standardAP
1990-02-16Manufacturing (CMC) · Supplement 24 · standardAP
1990-02-16Manufacturing (CMC) · Supplement 27 · standardAP
1990-01-22Labeling · Supplement 25AP
1990-01-22Labeling · Supplement 23AP
1989-06-28Manufacturing (CMC) · Supplement 26 · standardAP
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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