Details for New Drug Application (NDA): 091261
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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 091261
Tradename: | LEVETIRACETAM |
Applicant: | Apotex Inc |
Ingredient: | levetiracetam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091261
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 091261
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 091261 | ANDA | Golden State Medical Supply, Inc. | 60429-349 | 60429-349-60 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60429-349-60) |
LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 091261 | ANDA | Golden State Medical Supply, Inc. | 60429-350 | 60429-350-60 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60429-350-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Sep 12, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
Approval Date: | Sep 12, 2011 | TE: | AB | RLD: | No |
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