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): 206961
Company: NEXUS

Products on ANDA 206961

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206961

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/02/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206961

ISOPROTERENOL HYDROCHLORIDE

INJECTABLE;INJECTION; 0.2MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210576	AMNEAL
ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210106	AMPHASTAR PHARMS INC
ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	211237	AMRING PHARMS
ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	212189	AVET LIFESCIENCES
ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	217648	GLAND PHARMA LTD
ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	211703	HIKMA
ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	210845	MICRO LABS
ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206961	NEXUS
ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215542	PENN LIFE
ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	211590	SOMERSET THERAPS LLC

Top