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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209387
Company: EXELA PHARMA

Products on NDA 209387

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0.9%	SODIUM NITROPRUSSIDE	10MG/50ML (0.2MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209387

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

Labels for NDA 209387

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

Therapeutic Equivalents for NDA 209387

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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