Details for New Drug Application (NDA): 021802

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NDA 021802 describes FOCALIN XR, which is a drug marketed by Sandoz and is included in one NDA. It is available from two suppliers. Additional details are available on the FOCALIN XR profile page.

The generic ingredient in FOCALIN XR is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.

Summary for 021802

Tradename:	FOCALIN XR
Applicant:	Sandoz
Ingredient:	dexmethylphenidate hydrochloride
Patents:	0

Pharmacology for NDA: 021802

Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for 021802

Central Nervous System Stimulants
Dopamine Uptake Inhibitors

Suppliers and Packaging for NDA: 021802

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802	NDA	Novartis Pharmaceuticals Corporation	0078-0430	0078-0430-05	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0430-05)
FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802	NDA	Novartis Pharmaceuticals Corporation	0078-0431	0078-0431-05	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0431-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	5MG
Approval Date:	May 26, 2005	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	10MG
Approval Date:	May 26, 2005	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	20MG
Approval Date:	May 26, 2005	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021802

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-008	Apr 21, 2011	5,908,850	⤷ Get Started Free
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-005	Oct 23, 2009	5,908,850	⤷ Get Started Free
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-001	May 26, 2005	7,431,944	⤷ Get Started Free
Sandoz	FOCALIN XR	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021802-004	Aug 1, 2006	7,431,944	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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