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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 018163

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NDA 018163 describes RESTORIL, which is a drug marketed by Specgx Llc and is included in one NDA. It is available from four suppliers. Additional details are available on the RESTORIL profile page.

The generic ingredient in RESTORIL is temazepam. There are seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the temazepam profile page.

Summary for 018163

Tradename:	RESTORIL
Applicant:	Specgx Llc
Ingredient:	temazepam
Patents:	0

Pharmacology for NDA: 018163

Medical Subject Heading (MeSH) Categories for 018163

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 018163

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RESTORIL	temazepam	CAPSULE;ORAL	018163	NDA	SpecGx LLC	0406-9914	0406-9914-03	30 CAPSULE in 1 BOTTLE (0406-9914-03)
RESTORIL	temazepam	CAPSULE;ORAL	018163	NDA	SpecGx LLC	0406-9915	0406-9915-01	100 CAPSULE in 1 BOTTLE (0406-9915-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	7.5MG
Approval Date:	Oct 25, 1991	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018163

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991	5,030,632	⤷ Get Started Free
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991	5,326,758	⤷ Get Started Free
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991	5,211,954	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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