Details for New Drug Application (NDA): 205130
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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 205130
Tradename: | LEVETIRACETAM |
Applicant: | Sciegen Pharms Inc |
Ingredient: | levetiracetam |
Patents: | 0 |
Pharmacology for NDA: 205130
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 205130
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 205130 | ANDA | ScieGen Pharmaceuticals, Inc | 50228-189 | 50228-189-05 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-05) |
LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 205130 | ANDA | ScieGen Pharmaceuticals, Inc | 50228-189 | 50228-189-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-189-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | Nov 27, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
Approval Date: | Nov 27, 2020 | TE: | AB | RLD: | No |
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