Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219692
Company: SAGENT

Products on ANDA 219692

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219692

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219692

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

SOLUTION;INTRAVENOUS; EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	214313	BAXTER HLTHCARE CORP
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219692	SAGENT

SOLUTION;INTRAVENOUS; EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	214313	BAXTER HLTHCARE CORP
NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE	NOREPINEPHRINE BITARTRATE	EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	219692	SAGENT