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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 021278

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NDA 021278 describes FOCALIN, which is a drug marketed by Sandoz and is included in two NDAs. It is available from two suppliers. Additional details are available on the FOCALIN profile page.

The generic ingredient in FOCALIN 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 021278

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

Pharmacology for NDA: 021278

Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for 021278

Central Nervous System Stimulants
Dopamine Uptake Inhibitors

Suppliers and Packaging for NDA: 021278

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278	NDA	Novartis Pharmaceuticals Corporation	0078-0381	0078-0381-05	100 TABLET in 1 BOTTLE (0078-0381-05)
FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278	NDA	Sandoz Inc	66758-250	66758-250-01	100 TABLET in 1 BOTTLE (66758-250-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Nov 13, 2001	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Nov 13, 2001	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Nov 13, 2001	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021278

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-002	Nov 13, 2001	6,255,325	⤷ Get Started Free
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-001	Nov 13, 2001	5,908,850	⤷ Get Started Free
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-001	Nov 13, 2001	6,528,530	⤷ Get Started Free
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-003	Nov 13, 2001	6,528,530	⤷ Get Started Free
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-003	Nov 13, 2001	6,355,656	⤷ Get Started Free
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-002	Nov 13, 2001	5,908,850	⤷ Get Started Free
Sandoz	FOCALIN	dexmethylphenidate hydrochloride	TABLET;ORAL	021278-003	Nov 13, 2001	5,922,736	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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