Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021910
Company: DIALYSIS SUPS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORMOCARB HF 25 MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 0.21GM/100ML;2.8GM/100ML;9.07GM/100ML SOLUTION;INJECTION Prescription None Yes Yes
NORMOCARB HF 35 MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 0.21GM/100ML;3.97GM/100ML;8.3GM/100ML SOLUTION;INJECTION 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
07/26/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021910lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021910s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021910s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/01/2019 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021910s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021910Orig1s008ltr.pdf
06/22/2012 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021910s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021910s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/01/2019 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021910s008lbl.pdf
06/22/2012 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021910s005lbl.pdf
07/26/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021910lbl.pdf

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