Details for New Drug Application (NDA): 078976
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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 078976
Tradename: | LEVETIRACETAM |
Applicant: | Actavis Mid Atlantic |
Ingredient: | levetiracetam |
Patents: | 0 |
Pharmacology for NDA: 078976
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 078976
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | SOLUTION;ORAL | 078976 | ANDA | Actavis Pharma, Inc. | 0472-0235 | 0472-0235-16 | 473 mL in 1 BOTTLE, PLASTIC (0472-0235-16) |
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 |
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