Details for New Drug Application (NDA): 022285
✉ Email this page to a colleague
NDA 022285 describes KEPPRA XR, which is a drug marketed by Ucb Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the KEPPRA XR profile page.
The generic ingredient in KEPPRA XR is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-eight suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
The generic ingredient in KEPPRA XR is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-eight suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 022285
| Tradename: | KEPPRA XR |
| Applicant: | Ucb Inc |
| Ingredient: | levetiracetam |
| Patents: | 1 |
Pharmacology for NDA: 022285
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 022285
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KEPPRA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 022285 | NDA | UCB, Inc. | 50474-598 | 50474-598-66 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-598-66) |
| KEPPRA XR | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 022285 | NDA | UCB, Inc. | 50474-599 | 50474-599-66 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-599-66) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
| Approval Date: | Sep 12, 2008 | TE: | AB | RLD: | Yes | ||||
| Patent: | 7,858,122 | Patent Expiration: | Sep 17, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
| Approval Date: | Feb 12, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | 7,858,122 | Patent Expiration: | Sep 17, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
