Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021910
Company: DIALYSIS SUPS
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 |