Details for New Drug Application (NDA): 018163

✉ Email this page to a colleague

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-seven 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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991	⤷ Sign Up	⤷ Sign Up
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991	⤷ Sign Up	⤷ Sign Up
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.