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Moodys
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Accenture
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Fuji
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Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018708

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NDA 018708 describes DORAL, which is a drug marketed by Cutis Health Llc and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the DORAL profile page.

The generic ingredient in DORAL is quazepam. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the quazepam profile page.
Summary for 018708
Tradename:DORAL
Applicant:Cutis Health Llc
Ingredient:quazepam
Patents:1
Pharmacology for NDA: 018708
Ingredient-typeBenzodiazepines
Suppliers and Packaging for NDA: 018708
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DORAL quazepam TABLET;ORAL 018708 NDA Galt Pharmaceuticals LLC 61825-165 N 61825-165-10
DORAL quazepam TABLET;ORAL 018708 NDA Thompson Medical Solutions LLC 69874-322 E 69874-322-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Dec 27, 1985TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 3, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR TREATING INSOMNIA WHILE REDUCING THE RISK OF AN ADVERSE DRUG INTERACTION

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength7.5MG
Approval Date:Feb 26, 1987TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Jun 3, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR TREATING INSOMNIA WHILE REDUCING THE RISK OF AN ADVERSE DRUG INTERACTION

Expired US Patents for NDA 018708

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cutis Health Llc DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 ➤ Sign Up ➤ Sign Up
Cutis Health Llc DORAL quazepam TABLET;ORAL 018708-003 Feb 26, 1987 ➤ Sign Up ➤ Sign Up
Cutis Health Llc DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 ➤ Sign Up ➤ Sign Up
Cutis Health Llc DORAL quazepam TABLET;ORAL 018708-003 Feb 26, 1987 ➤ Sign Up ➤ Sign Up
Cutis Health Llc DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 ➤ Sign Up ➤ Sign Up
Cutis Health Llc DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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