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Generated: November 19, 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 Galt Pharms 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:Galt Pharms
Ingredient:quazepam
Patents:1
Generic Entry Opportunity 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.

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 61825-165-10 100 TABLET in 1 BOTTLE (61825-165-10)
DORAL quazepam TABLET;ORAL 018708 NDA Atland Pharmaceuticals, LLC 71993-265 71993-265-10 100 TABLET in 1 BOTTLE (71993-265-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Dec 27, 1985TE:RLD:Yes
Patent:➤ Try a Free TrialPatent 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:➤ Try a Free TrialPatent 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 018708-003 Feb 26, 1987 ➤ Try a Free Trial ➤ Try a Free Trial
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 ➤ Try a Free Trial ➤ Try a Free Trial
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 ➤ Try a Free Trial ➤ Try a Free Trial
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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