Details for New Drug Application (NDA): 021121

✉ Email this page to a colleague

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-seven 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

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-002	Aug 1, 2000	⤷ Subscribe	⤷ Subscribe
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-003	Dec 8, 2000	⤷ Subscribe	⤷ Subscribe
Janssen Pharms	CONCERTA	methylphenidate hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021121-001	Aug 1, 2000	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.