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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/28/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21117ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021117_CalciumChloride.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2021 SUPPL-24 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021117s024lbl.pdf
07/25/2018 SUPPL-15 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021117s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021117Orig1s015Ltr.pdf
03/18/2003 SUPPL-2 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21117scs002ltr.pdf
09/01/2000 SUPPL-1 Labeling

Label is not available on this site.

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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021117s015lbl.pdf
07/25/2018 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021117s015lbl.pdf

CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 100MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CALCIUM CHLORIDE 10% CALCIUM CHLORIDE 100MG/ML INJECTABLE;INJECTION Prescription No AP 209088 AM REGENT
CALCIUM CHLORIDE 10% CALCIUM CHLORIDE 100MG/ML INJECTABLE;INJECTION Prescription No AP 203477 INTL MEDICATION SYS
CALCIUM CHLORIDE 10% CALCIUM CHLORIDE 100MG/ML INJECTABLE;INJECTION Prescription No AP 211553 MEDEFIL INC
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER CALCIUM CHLORIDE 100MG/ML INJECTABLE;INJECTION Prescription Yes AP 021117 HOSPIRA
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