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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 018708


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NDA 018708 describes DORAL, which is a drug marketed by Galt Pharms and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the quazepam profile page.
Summary for 018708
Tradename:DORAL
Applicant:Galt Pharms
Ingredient:quazepam
Patents:1
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 018708
Generic Entry Date for 018708*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 AUTHORIZED GENERIC Atland Pharmaceuticals, LLC 71993-265 71993-265-30 30 TABLET in 1 BOTTLE (71993-265-30)

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
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 ⤷  Sign Up ⤷  Sign Up
Galt Pharms DORAL quazepam TABLET;ORAL 018708-003 Feb 26, 1987 ⤷  Sign Up ⤷  Sign Up
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 ⤷  Sign Up ⤷  Sign Up
Galt Pharms 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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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.