Details for New Drug Application (NDA): 213532
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The generic ingredient in LEVETIRACETAM IN SODIUM CHLORIDE 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 213532
Tradename: | LEVETIRACETAM IN SODIUM CHLORIDE |
Applicant: | Nexus |
Ingredient: | levetiracetam |
Patents: | 0 |
Pharmacology for NDA: 213532
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 213532
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 213532 | ANDA | Nexus Pharmaceuticals LLC | 14789-110 | 14789-110-05 | 10 BAG in 1 CARTON (14789-110-05) / 100 mL in 1 BAG (14789-110-08) |
LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 213532 | ANDA | Nexus Pharmaceuticals LLC | 14789-220 | 14789-220-10 | 10 BAG in 1 CARTON (14789-220-10) / 100 mL in 1 BAG (14789-220-08) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 500MG/100ML (5MG/ML) | ||||
Approval Date: | Jul 6, 2020 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 1GM/100ML (10MG/ML) | ||||
Approval Date: | Jul 6, 2020 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 1.5GM/100ML (15MG/ML) | ||||
Approval Date: | Jul 6, 2020 | TE: | AP | RLD: | No |
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