Details for New Drug Application (NDA): 203308
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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 203308
Tradename: | LEVETIRACETAM |
Applicant: | Mylan Labs Ltd |
Ingredient: | levetiracetam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203308
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 203308
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | INJECTABLE;INTRAVENOUS | 203308 | ANDA | Mylan Institutional LLC | 67457-790 | 67457-790-05 | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-790-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-790-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 500MG/5ML (100MG/ML) | ||||
Approval Date: | Sep 16, 2016 | TE: | AP | RLD: | No |
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