Details for New Drug Application (NDA): 212688
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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 212688
Tradename: | LEVETIRACETAM |
Applicant: | Overseas |
Ingredient: | levetiracetam |
Patents: | 0 |
Pharmacology for NDA: 212688
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 212688
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 212688 | ANDA | Omnivium Pharmaceuticals LLC | 81665-100 | 81665-100-12 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-100-12) |
LEVETIRACETAM | levetiracetam | TABLET, EXTENDED RELEASE;ORAL | 212688 | ANDA | Omnivium Pharmaceuticals LLC | 81665-100 | 81665-100-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (81665-100-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
Approval Date: | Jun 11, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG | ||||
Approval Date: | May 5, 2023 | TE: | AB | RLD: | No |
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