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Last Updated: March 19, 2024

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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021121
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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength18MG
Approval Date:Aug 1, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength36MG
Approval Date:Aug 1, 2000TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength54MG
Approval Date:Dec 8, 2000TE:ABRLD:Yes

Expired US Patents for NDA 021121

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 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-003 Dec 8, 2000 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms CONCERTA methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 021121-001 Aug 1, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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