An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210882
Company: SOMERSET THERAPS LLC

Products on ANDA 210882

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 210882

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2020	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210882

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

Top