Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 213645
Company: BAXTER HLTHCARE CORP
Company: BAXTER HLTHCARE CORP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | DAPTOMYCIN | 350MG/50ML (7MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | DAPTOMYCIN | 500MG/50ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | DAPTOMYCIN | 700MG/100ML (7MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | DAPTOMYCIN | 1GM/100ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
DAPZURA RT | DAPTOMYCIN | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | POWDER;INTRAVENOUS | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/25/2022 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213645s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213645Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/213645Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/27/2023 | SUPPL-1 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213645s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213645Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/27/2023 | SUPPL-1 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213645s001lbl.pdf | |
01/25/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213645s000lbl.pdf |