Details for New Drug Application (NDA): 021035
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The generic ingredient in KEPPRA is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 021035
Tradename: | KEPPRA |
Applicant: | Ucb Inc |
Ingredient: | levetiracetam |
Patents: | 1 |
Pharmacology for NDA: 021035
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 021035
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KEPPRA | levetiracetam | TABLET;ORAL | 021035 | NDA | UCB, Inc. | 50474-594 | 50474-594-40 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-594-40) |
KEPPRA | levetiracetam | TABLET;ORAL | 021035 | NDA | UCB, Inc. | 50474-595 | 50474-595-40 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50474-595-40) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Nov 30, 1999 | TE: | AB | RLD: | Yes | ||||
Patent: | 8,802,142*PED | Patent Expiration: | Dec 7, 2031 | Product Flag? | Substance Flag? | Delist Request? | Y |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Nov 30, 1999 | TE: | AB | RLD: | Yes | ||||
Patent: | 8,802,142*PED | Patent Expiration: | Dec 7, 2031 | Product Flag? | Substance Flag? | Delist Request? | Y |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
Approval Date: | Nov 30, 1999 | TE: | AB | RLD: | Yes | ||||
Patent: | 8,802,142*PED | Patent Expiration: | Dec 7, 2031 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 021035
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-002 | Nov 30, 1999 | 4,943,639*PED | ⤷ Subscribe |
Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-004 | Jan 6, 2006 | 4,943,639*PED | ⤷ Subscribe |
Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-003 | Nov 30, 1999 | 4,943,639*PED | ⤷ Subscribe |
Ucb Inc | KEPPRA | levetiracetam | TABLET;ORAL | 021035-003 | Nov 30, 1999 | 4,837,223 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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