Details for New Drug Application (NDA): 213645
✉ Email this page to a colleague
NDA 213645 describes DAPTOMYCIN IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from one supplier. Additional details are available on the DAPTOMYCIN IN 0.9% SODIUM CHLORIDE profile page.
The generic ingredient in DAPTOMYCIN IN 0.9% SODIUM CHLORIDE is daptomycin. There are ten drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the daptomycin profile page.
The generic ingredient in DAPTOMYCIN IN 0.9% SODIUM CHLORIDE is daptomycin. There are ten drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the daptomycin profile page.
Summary for 213645
| Tradename: | DAPTOMYCIN IN 0.9% SODIUM CHLORIDE |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | daptomycin |
| Patents: | 1 |
Suppliers and Packaging for NDA: 213645
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAPZURA RT | daptomycin | POWDER;INTRAVENOUS | 213645 | NDA | Baxter Healthcare Corporation | 0338-0712 | 0338-0712-24 | 24 BAG in 1 CARTON (0338-0712-24) / 50 mL in 1 BAG |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | daptomycin | SOLUTION;INTRAVENOUS | 213645 | NDA | Baxter Healthcare Corporation | 0338-0712 | 0338-0712-24 | 24 BAG in 1 CARTON (0338-0712-24) / 50 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 25, 2022 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 11, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF TREATING A BACTERIAL INFECTION BY ADMINISTERING A RECONSTITUTED SOLID FORMULATION OF DAPTOMYCIN CONTAINING 31.0 TO 59.4% WT TOTAL MANNITOL AND SORBITOL | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 350MG/50ML (7MG/ML) | ||||
| Approval Date: | Feb 27, 2023 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 500MG/50ML (10MG/ML) | ||||
| Approval Date: | Feb 27, 2023 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
