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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211016
Company: CAPLIN

Products on ANDA 211016

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 211016

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211016

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	214199	HAINAN POLY PHARM
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	209584	MYLAN
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	207426	SAGENT PHARMS INC
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210882	SOMERSET THERAPS LLC
SODIUM NITROPRUSSIDE	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	211277	XIROMED

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