Details for New Drug Application (NDA): 021121

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NDA 021121 describes CONCERTA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the CONCERTA profile page.

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

Summary for 021121

Tradename:	CONCERTA
Applicant:	Janssen Pharms
Ingredient:	methylphenidate hydrochloride
Patents:	0

Pharmacology for NDA: 021121

Physiological Effect	Central Nervous System Stimulation

Suppliers and Packaging for NDA: 021121

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121	NDA	Patriot Pharmaceuticals, LLC.	10147-0685	10147-0685-1	100 TABLET in 1 BOTTLE (10147-0685-1)
CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121	NDA AUTHORIZED GENERIC	Patriot Pharmaceuticals, LLC.	10147-0686	10147-0686-1	100 TABLET in 1 BOTTLE (10147-0686-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	18MG
Approval Date:	Aug 1, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	36MG
Approval Date:	Aug 1, 2000	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	54MG
Approval Date:	Dec 8, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021121

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-003	Dec 8, 2000	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-004	Apr 1, 2002	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-003	Dec 8, 2000	⤷ Sign Up	⤷ Sign Up
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