Details for New Drug Application (NDA): 208619
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NDA 208619 describes LEVETIRACETAM IN SODIUM CHLORIDE, which is a drug marketed by B Braun Medical, Baxter Hlthcare Corp, Caplin, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hq Spclt Pharma, and Nexus, and is included in nine NDAs. It is available from fifteen suppliers. Additional details are available on the LEVETIRACETAM IN SODIUM CHLORIDE profile page.
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.
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 208619
| Tradename: | LEVETIRACETAM IN SODIUM CHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | levetiracetam |
| Patents: | 0 |
Pharmacology for NDA: 208619
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 208619
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 208619 | ANDA | Fresenius Kabi USA, LLC | 65219-042 | 65219-042-71 | 24 BAG in 1 CARTON (65219-042-71) / 100 mL in 1 BAG (65219-042-21) |
| LEVETIRACETAM IN SODIUM CHLORIDE | levetiracetam | INJECTABLE;INTRAVENOUS | 208619 | ANDA | Fresenius Kabi USA, LLC | 65219-044 | 65219-044-71 | 24 BAG in 1 CARTON (65219-044-71) / 100 mL in 1 BAG (65219-044-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 500MG/100ML (5MG/ML) | ||||
| Approval Date: | Jan 31, 2023 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 1GM/100ML (10MG/ML) | ||||
| Approval Date: | Jan 31, 2023 | 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: | Jan 31, 2023 | TE: | AP | RLD: | No | ||||
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