Details for New Drug Application (NDA): 021872
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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 021872
Tradename: | KEPPRA |
Applicant: | Ucb Inc |
Ingredient: | levetiracetam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021872
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 021872
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KEPPRA | levetiracetam | INJECTABLE;INTRAVENOUS | 021872 | NDA | UCB, Inc. | 50474-002 | 50474-002-63 | 10 VIAL, SINGLE-USE in 1 CARTON (50474-002-63) / 5 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 500MG/5ML (100MG/ML) | ||||
Approval Date: | Jul 31, 2006 | TE: | AP | RLD: | Yes |
Expired US Patents for NDA 021872
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ucb Inc | KEPPRA | levetiracetam | INJECTABLE;INTRAVENOUS | 021872-001 | Jul 31, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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