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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

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 five 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. Thirty 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 018163
Medical Subject Heading (MeSH) Categories for 018163
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)
Paragraph IV (Patent) Challenges for 018163
Tradename Dosage Ingredient NDA Submissiondate
RESTORIL CAPSULE;ORAL temazepam 018163 2006-11-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength7.5MG
Approval Date:Oct 25, 1991TE:ABRLD:Yes

Expired US Patents for NDA 018163

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991   Start Trial   Start Trial
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991   Start Trial   Start Trial
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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