Details for New Drug Application (NDA): 090876
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The generic ingredient in LEVETIRACETAM is levetiracetam. There are thirty-five drug master file entries for this compound. Eighty-seven suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 090876
Tradename: | LEVETIRACETAM |
Applicant: | Fresenius Kabi Usa |
Ingredient: | levetiracetam |
Patents: | 0 |
Pharmacology for NDA: 090876
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 090876
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | INJECTABLE;INTRAVENOUS | 090876 | ANDA | Fresenius Kabi USA, LLC | 63323-400 | 63323-400-05 | 10 VIAL, SINGLE-USE in 1 TRAY (63323-400-05) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-01) |
LEVETIRACETAM | levetiracetam | INJECTABLE;INTRAVENOUS | 090876 | ANDA | Fresenius Kabi USA, LLC | 63323-400 | 63323-400-44 | 10 VIAL, SINGLE-USE in 1 TRAY (63323-400-44) / 5 mL in 1 VIAL, SINGLE-USE (63323-400-41) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 500MG/5ML (100MG/ML) | ||||
Approval Date: | Aug 13, 2015 | TE: | AP | RLD: | No |
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