Details for New Drug Application (NDA): 211359

NDA 211359 describes NOREPINEPHRINE BITARTRATE, which is a drug marketed by Amneal, Baxter Hlthcare Corp, Breckenridge, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Meitheal, Metrics Pharm, Mylan Labs Ltd, Rising, Sandoz, Sun Pharm, Zydus Pharms, Inforlife, and Long Grove Pharms, and is included in eighteen NDAs. It is available from twenty suppliers. There are eight patents protecting this drug. Additional details are available on the NOREPINEPHRINE BITARTRATE profile page.

The generic ingredient in NOREPINEPHRINE BITARTRATE is norepinephrine bitartrate. There are five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.

Summary for 211359

Tradename:	NOREPINEPHRINE BITARTRATE
Applicant:	Sandoz
Ingredient:	norepinephrine bitartrate
Patents:	0

Pharmacology for NDA: 211359

Medical Subject Heading (MeSH) Categories for 211359

Adrenergic alpha-Agonists

Sympathomimetics

Vasoconstrictor Agents

Suppliers and Packaging for NDA: 211359

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	211359	ANDA	Sandoz Inc	0781-3755	0781-3755-95	10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3755-95) / 4 mL in 1 VIAL, SINGLE-DOSE (0781-3755-75)
NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	211359	ANDA	Civica, Inc.	72572-481	72572-481-10	10 VIAL, SINGLE-DOSE in 1 CARTON (72572-481-10) / 4 mL in 1 VIAL, SINGLE-DOSE (72572-481-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/ML
Approval Date:	Oct 18, 2018	TE:	AP	RLD:	No

Complete Access Available with Subscription