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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 021284

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NDA 021284 describes RITALIN LA, 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 RITALIN LA profile page.

The generic ingredient in RITALIN LA is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.

Summary for 021284

Tradename:	RITALIN LA
Applicant:	Sandoz
Ingredient:	methylphenidate hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021284

Physiological Effect	Central Nervous System Stimulation

Suppliers and Packaging for NDA: 021284

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284	NDA	Novartis Pharmaceuticals Corporation	0078-0370	0078-0370-05	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0370-05)
RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284	NDA	Novartis Pharmaceuticals Corporation	0078-0371	0078-0371-05	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0371-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	20MG
Approval Date:	Jun 5, 2002	TE:	AB1	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	30MG
Approval Date:	Jun 5, 2002	TE:	AB1	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	40MG
Approval Date:	Jun 5, 2002	TE:	AB1	RLD:	Yes

Expired US Patents for NDA 021284

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-004	Apr 10, 2004	⤷ Try a Trial	⤷ Try a Trial
Sandoz	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-004	Apr 10, 2004	⤷ Try a Trial	⤷ Try a Trial
Sandoz	RITALIN LA	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021284-001	Jun 5, 2002	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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