Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210839
Company: AMNEAL

Products on ANDA 210839

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210839

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2018	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
10/30/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210839

NOREPINEPHRINE BITARTRATE

INJECTABLE;INJECTION; EQ 1MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LEVOPHED	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	007513	HOSPIRA
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	210839	AMNEAL
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	040859	BAXTER HLTHCARE CORP
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	214455	BRECKENRIDGE
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	217575	CAPLIN
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	211382	FRESENIUS KABI USA
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	214323	GLAND PHARMA LTD
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	040462	HIKMA
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	203662	HIKMA
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	040455	MEITHEAL
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	211242	MYLAN LABS LTD
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	218758	RISING
NOREPINEPHRINE BITARTRATE	NOREPINEPHRINE BITARTRATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	211359	SANDOZ