Details for New Drug Application (NDA): 079063
✉ Email this page to a colleague
The generic ingredient in LEVETIRACETAM 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 079063
Tradename: | LEVETIRACETAM |
Applicant: | Aurobindo Pharma |
Ingredient: | levetiracetam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 079063
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 079063
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | SOLUTION;ORAL | 079063 | ANDA | NorthStar Rx LLC | 16714-358 | 16714-358-01 | 473 mL in 1 BOTTLE, PLASTIC (16714-358-01) |
LEVETIRACETAM | levetiracetam | SOLUTION;ORAL | 079063 | ANDA | Aurobindo Pharma Limited | 65862-250 | 65862-250-05 | 500 mL in 1 BOTTLE, PLASTIC (65862-250-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 100MG/ML | ||||
Approval Date: | Jan 15, 2009 | TE: | AA | RLD: | No |
Complete Access Available with Subscription