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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213645
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DAPZURA RT DAPTOMYCIN 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** POWDER;INTRAVENOUS Discontinued None Yes No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
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