Details for New Drug Application (NDA): 090992
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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 090992
Tradename: | LEVETIRACETAM |
Applicant: | Amneal Pharms |
Ingredient: | levetiracetam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090992
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 090992
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | SOLUTION;ORAL | 090992 | ANDA | Amneal Pharmaceuticals LLC | 65162-685 | 65162-685-86 | 118 mL in 1 BOTTLE (65162-685-86) |
LEVETIRACETAM | levetiracetam | SOLUTION;ORAL | 090992 | ANDA | Amneal Pharmaceuticals LLC | 65162-685 | 65162-685-90 | 473 mL in 1 BOTTLE (65162-685-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 100MG/ML | ||||
Approval Date: | Oct 27, 2009 | TE: | AA | RLD: | No |
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