Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215846
Company: HAINAN POLY

Products on ANDA 215846

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	10MG/50ML (0.2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	None	No	No
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	20MG/100ML (0.2MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	50MG/100ML (0.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215846

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215846Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 215846

SODIUM NITROPRUSSIDE

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	HAINAN POLY

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	HAINAN POLY