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 Inc, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, and Nexus, and is included in eight NDAs. It is available from ten 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-six 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-six 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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 500MG/100ML (5MG/ML) | ||||
| Approval Date: | Jan 31, 2023 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 1GM/100ML (10MG/ML) | ||||
| Approval Date: | Jan 31, 2023 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 1.5GM/100ML (15MG/ML) | ||||
| Approval Date: | Jan 31, 2023 | TE: | RLD: | No | |||||
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