Details for New Drug Application (NDA): 022510

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NDA 022510 describes ABSTRAL, which is a drug marketed by Sentynl Theraps Inc and is included in one NDA. Additional details are available on the ABSTRAL profile page.

The generic ingredient in ABSTRAL is fentanyl citrate. There are thirty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

Summary for 022510

Tradename:	ABSTRAL
Applicant:	Sentynl Theraps Inc
Ingredient:	fentanyl citrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;SUBLINGUAL			Strength	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 7, 2011	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;SUBLINGUAL			Strength	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 7, 2011	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;SUBLINGUAL			Strength	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 7, 2011	TE:		RLD:	Yes

Expired US Patents for NDA 022510

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-004	Jan 7, 2011	6,759,059	⤷ Subscribe
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-006	Jan 7, 2011	6,761,910	⤷ Subscribe
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-005	Jan 7, 2011	6,761,910	⤷ Subscribe
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-002	Jan 7, 2011	6,761,910	⤷ Subscribe
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-003	Jan 7, 2011	7,910,132	⤷ Subscribe
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-001	Jan 7, 2011	6,759,059	⤷ Subscribe
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