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Generated: May 26, 2017

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Details for New Drug Application (NDA): 018163

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NDA 018163 describes RESTORIL, which is a drug marketed by Mallinckrodt Inc 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. Forty-one suppliers are listed for this compound. Additional details are available on the temazepam profile page.

Summary for NDA: 018163

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 018163

Ingredient-typeBenzodiazepines

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 KAISER FOUNDATION HOSPITALS 0179-0045 0179-0045-70 30 CAPSULE in 1 BOX, UNIT-DOSE (0179-0045-70)
RESTORIL
temazepam
CAPSULE;ORAL 018163 NDA Mallinckrodt, Inc. 0406-9914 0406-9914-03 30 CAPSULE in 1 BOTTLE (0406-9914-03)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 018163

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Inc
RESTORIL
temazepam
CAPSULE;ORAL018163-003Oct 25, 19915,326,758► Subscribe
Mallinckrodt Inc
RESTORIL
temazepam
CAPSULE;ORAL018163-003Oct 25, 19915,030,632► Subscribe
Mallinckrodt Inc
RESTORIL
temazepam
CAPSULE;ORAL018163-003Oct 25, 19915,211,954► Subscribe
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