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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 four 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. Four suppliers are listed for this compound. Additional details are available on the quazepam profile page.

Summary for NDA: 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 A-S Medication Solutions LLC 50090-1474 50090-1474-0 60 TABLET in 1 BOTTLE (50090-1474-0)
DORAL
quazepam
TABLET;ORAL 018708 NDA Unit Dose Services 50436-0405 50436-0405-1 30 TABLET in 1 BOTTLE (50436-0405-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Dec 27, 1985TE:RLD:Yes
Patent:7,608,616Patent Expiration:Jun 3, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR TREATING INSOMNIA WHILE REDUCING THE RISK OF AN ADVERSE DRUG INTERACTION

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength7.5MG
Approval Date:Feb 26, 1987TE:RLD:No
Patent:7,608,616Patent 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 Orange Book Patents for NDA: 018708

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cutis Health Llc
DORAL
quazepam
TABLET;ORAL018708-003Feb 26, 19873,845,039► subscribe
Cutis Health Llc
DORAL
quazepam
TABLET;ORAL018708-001Dec 27, 19854,128,658► subscribe
Cutis Health Llc
DORAL
quazepam
TABLET;ORAL018708-001Dec 27, 19853,920,818► subscribe
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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 verifification 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.

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