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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021117
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER CALCIUM CHLORIDE 100MG/ML INJECTABLE;INJECTION Prescription AP Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/31/2021 SUPPL-24 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021117s024lbl.pdf
07/25/2018 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021117s015lbl.pdf
07/25/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021117s015lbl.pdf
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