Details for New Drug Application (NDA): 209705
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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-six suppliers are listed for this compound. Additional details are available on the levetiracetam profile page.
Summary for 209705
| Tradename: | LEVETIRACETAM IN SODIUM CHLORIDE |
| Applicant: | B Braun Medical |
| Ingredient: | levetiracetam |
| Patents: | 0 |
Pharmacology for NDA: 209705
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 209705
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 209705 | ANDA | B. Braun Medical Inc. | 0264-1009 | 0264-1009-90 | 24 CONTAINER in 1 CASE (0264-1009-90) / 100 mL in 1 CONTAINER |
| LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 209705 | ANDA | B. Braun Medical Inc. | 0264-1509 | 0264-1509-90 | 24 CONTAINER in 1 CASE (0264-1509-90) / 100 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 500MG/100ML (5MG/ML) | ||||
| Approval Date: | Feb 27, 2024 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 1GM/100ML (10MG/ML) | ||||
| Approval Date: | Feb 27, 2024 | 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: | Feb 27, 2024 | TE: | AP | RLD: | No | ||||
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