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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021910
Company: DIALYSIS SUPS

Products on NDA 021910

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021910

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

Labels for NDA 021910

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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