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 one supplier. 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-five suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
The generic ingredient in CONCERTA is methylphenidate hydrochloride. There are thirty-two drug master file entries for this compound. Forty-five 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 | Janssen Pharmaceuticals, Inc. | 50458-585 | 50458-585-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-585-01) |
| CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121 | NDA | Janssen Pharmaceuticals, Inc. | 50458-586 | 50458-586-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-586-01) |
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
| 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 | ⤷ Get Started Free | ⤷ Get Started Free |
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-003 | Dec 8, 2000 | ⤷ Get Started Free | ⤷ Get Started Free |
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-001 | Aug 1, 2000 | ⤷ Get Started Free | ⤷ Get Started Free |
| Janssen Pharms | CONCERTA | methylphenidate hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021121-002 | Aug 1, 2000 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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