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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208418
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALCIUM GLUCONATE CALCIUM GLUCONATE 1GM/10ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
CALCIUM GLUCONATE CALCIUM GLUCONATE 5GM/50ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
CALCIUM GLUCONATE CALCIUM GLUCONATE 10GM/100ML (100MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
CALCIUM GLUCONATE IN SODIUM CHLORIDE CALCIUM GLUCONATE 1GM/50ML (20MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
CALCIUM GLUCONATE IN SODIUM CHLORIDE CALCIUM GLUCONATE 2GM/100ML (20MG/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/15/2017 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208418s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208418Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208418Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/29/2021 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208418s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208418Orig1s011ltr.pdf
06/17/2021 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/0208418s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208418Orig1s007ltr.pdf
12/22/2017 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/208418Orig1s001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/29/2021 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208418s011lbl.pdf
06/17/2021 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/0208418s007lbl.pdf
06/15/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208418s000lbl.pdf
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