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^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 7,608,616 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:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Dec 27, 1985	TE:		RLD:	Yes
Patent:	7,608,616	Patent Expiration:	Jun 3, 2028	Product 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:	DISCN	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Feb 26, 1987	TE:		RLD:	No
Patent:	7,608,616	Patent Expiration:	Jun 3, 2028	Product 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985	4,128,658	⤷ Subscribe
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-003	Feb 26, 1987	3,845,039	⤷ Subscribe
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708-001	Dec 27, 1985	4,521,431	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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