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-five suppliers are listed for this compound. Additional details are available on the methylphenidate hydrochloride profile page.
The generic ingredient in RITALIN LA 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 021284
| Tradename: | RITALIN LA |
| Applicant: | Sandoz |
| Ingredient: | methylphenidate hydrochloride |
| Patents: | 0 |
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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