Details for New Drug Application (NDA): 017525

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NDA 017525 describes LOXITANE, which is a drug marketed by Teva Branded Pharm and Actavis Labs Ut Inc and is included in three NDAs. Additional details are available on the LOXITANE profile page.

The generic ingredient in LOXITANE is loxapine hydrochloride. There are eight drug master file entries for this compound. Additional details are available on the loxapine hydrochloride profile page.

Summary for 017525

Tradename:	LOXITANE
Applicant:	Teva Branded Pharm
Ingredient:	loxapine succinate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 017525

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-001	Approved Prior to Jan 1, 1982	3,546,226	⤷ Subscribe
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-004	Approved Prior to Jan 1, 1982	3,546,226	⤷ Subscribe
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-002	Approved Prior to Jan 1, 1982	3,546,226	⤷ Subscribe
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-003	Approved Prior to Jan 1, 1982	3,546,226	⤷ Subscribe
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