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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209387
Company: EXELA PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% SODIUM NITROPRUSSIDE 10MG/50ML (0.2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;INTRAVENOUS Discontinued None Yes No
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION;INTRAVENOUS 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
03/08/2017 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209387s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209387Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209387Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/13/2018 SUPPL-4 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209387s004lbl.pdf
05/23/2018 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209387Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/13/2018 SUPPL-4 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209387s004lbl.pdf
05/23/2018 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s003lbl.pdf
05/23/2018 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020937s003lbl.pdf
03/08/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209387s000lbl.pdf

NIPRIDE RTU IN SODIUM CHLORIDE 0.9%

SOLUTION;INTRAVENOUS; 50MG/100ML (0.5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 209387 EXELA PHARMA
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 50MG/100ML (0.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 215846 SLATE RUN PHARMA

SOLUTION;INTRAVENOUS; 20MG/100ML (0.2MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NIPRIDE RTU IN SODIUM CHLORIDE 0.9% SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 209387 EXELA PHARMA
SODIUM NITROPRUSSIDE SODIUM NITROPRUSSIDE 20MG/100ML (0.2MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 215846 SLATE RUN PHARMA
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