Details for New Drug Application (NDA): 217591
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NDA 217591 describes DALBAVANCIN HYDROCHLORIDE, which is a drug marketed by Fresenius Kabi Usa, Kindos, and Teva Pharms Inc, and is included in three NDAs. It is available from three suppliers. Additional details are available on the DALBAVANCIN HYDROCHLORIDE profile page.
The generic ingredient in DALBAVANCIN HYDROCHLORIDE is dalbavancin hydrochloride. Four suppliers are listed for this compound. Additional details are available on the dalbavancin hydrochloride profile page.
The generic ingredient in DALBAVANCIN HYDROCHLORIDE is dalbavancin hydrochloride. Four suppliers are listed for this compound. Additional details are available on the dalbavancin hydrochloride profile page.
Summary for 217591
| Tradename: | DALBAVANCIN HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | dalbavancin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217591
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DALBAVANCIN HYDROCHLORIDE | dalbavancin hydrochloride | POWDER;INTRAVENOUS | 217591 | ANDA | Fresenius Kabi USA, LLC | 65219-120 | 65219-120-12 | 1 VIAL in 1 PACKAGE (65219-120-12) / 25 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Nov 10, 2025 | TE: | AP | RLD: | No | ||||
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