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Details for New Drug Application (NDA): 021505

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NDA 021505 describes KEPPRA, which is a drug marketed by Ucb Inc and is included in four NDAs. It is available from seven suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the KEPPRA profile page.

The generic ingredient in KEPPRA is levetiracetam. There are thirty-four drug master file entries for this compound. Ninety suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the levetiracetam profile page.

Summary for NDA: 021505

Tradename:
KEPPRA
Applicant:
Ucb Inc
Ingredient:
levetiracetam
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 021505

Suppliers and Packaging for NDA: 021505

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KEPPRA
levetiracetam
SOLUTION;ORAL 021505 NDA UCB, Inc. 50474-001 50474-001-48 473 mL in 1 BOTTLE, PLASTIC (50474-001-48)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/ML
Approval Date:Jul 15, 2003TE:AARLD:Yes

Expired Orange Book Patents for NDA: 021505

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc
KEPPRA
levetiracetam
SOLUTION;ORAL021505-001Jul 15, 20034,837,223► subscribe
Ucb Inc
KEPPRA
levetiracetam
SOLUTION;ORAL021505-001Jul 15, 20034,943,639*PED► subscribe
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