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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207426
Company: SAGENT PHARMS INC

Products on ANDA 207426

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207426

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207426Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207426Orig1s000ltr.pdf

Labels for ANDA 207426

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207426Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 207426

SODIUM NITROPRUSSIDE

INJECTABLE;INJECTION; 25MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209493	AMNEAL
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	214971	BE PHARMS
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	211016	CAPLIN
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210114	DR REDDYS
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209352	MICRO LABS
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210763	MYLAN LABS LTD
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207499	NEXUS
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	209584	PHARMOBEDIENT
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207426	SAGENT PHARMS INC
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	214199	SLATE RUN PHARMA
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210882	SOMERSET THERAPS LLC

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