Details for New Drug Application (NDA): 020897

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NDA 020897 describes DITROPAN XL, which is a drug marketed by Janssen Pharms and is included in one NDA. Additional details are available on the DITROPAN XL profile page.

The generic ingredient in DITROPAN XL is oxybutynin chloride. There are sixteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.

Summary for 020897

Tradename:	DITROPAN XL
Applicant:	Janssen Pharms
Ingredient:	oxybutynin chloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 16, 1998	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 16, 1998	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 22, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 020897

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-002	Dec 16, 1998	6,262,115*PED	⤷ Get Started Free
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-002	Dec 16, 1998	5,912,268*PED	⤷ Get Started Free
Janssen Pharms	DITROPAN XL	oxybutynin chloride	TABLET, EXTENDED RELEASE;ORAL	020897-001	Dec 16, 1998	5,912,268*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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