Details for New Drug Application (NDA): 090981
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The generic ingredient in LEVETIRACETAM is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-four suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 090981
Tradename: | LEVETIRACETAM |
Applicant: | Hikma Farmaceutica |
Ingredient: | levetiracetam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090981
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 090981
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | INJECTABLE;INTRAVENOUS | 090981 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9574 | 0143-9574-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01) |
LEVETIRACETAM | levetiracetam | INJECTABLE;INTRAVENOUS | 090981 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9574 | 0143-9574-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0143-9574-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9574-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 500MG/5ML (100MG/ML) | ||||
Approval Date: | Oct 13, 2011 | TE: | AP | RLD: | No |
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