Details for New Drug Application (NDA): 078154
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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 078154
Tradename: | LEVETIRACETAM |
Applicant: | Lupin |
Ingredient: | levetiracetam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078154
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 078154
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | TABLET;ORAL | 078154 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-617 | 43063-617-60 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-617-60) |
LEVETIRACETAM | levetiracetam | TABLET;ORAL | 078154 | ANDA | DIRECT RX | 61919-685 | 61919-685-30 | 30 TABLET, FILM COATED in 1 BOTTLE (61919-685-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Jan 15, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jan 15, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
Approval Date: | Jan 15, 2009 | TE: | AB | RLD: | No |
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