Details for New Drug Application (NDA): 076919
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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 076919
Tradename: | LEVETIRACETAM |
Applicant: | Mylan |
Ingredient: | levetiracetam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076919
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 076919
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | TABLET;ORAL | 076919 | ANDA | Mylan Pharmaceuticals Inc. | 0378-5615 | 0378-5615-05 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5615-05) |
LEVETIRACETAM | levetiracetam | TABLET;ORAL | 076919 | ANDA | Mylan Pharmaceuticals Inc. | 0378-5615 | 0378-5615-78 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5615-78) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Nov 4, 2008 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Nov 4, 2008 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
Approval Date: | Nov 4, 2008 | TE: | AB | RLD: | No |
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