Details for New Drug Application (NDA): 090767
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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 090767
Tradename: | LEVETIRACETAM |
Applicant: | Rising |
Ingredient: | levetiracetam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090767
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 090767
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | TABLET;ORAL | 090767 | ANDA | Laurus Generics Inc. | 42385-954 | 42385-954-12 | 120 TABLET in 1 BOTTLE (42385-954-12) |
LEVETIRACETAM | levetiracetam | TABLET;ORAL | 090767 | ANDA | Laurus Generics Inc. | 42385-955 | 42385-955-05 | 500 TABLET in 1 BOTTLE (42385-955-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Jul 28, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jul 28, 2010 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
Approval Date: | Jul 28, 2010 | TE: | AB | RLD: | No |
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