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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 219924

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NDA 219924 describes NOREPINEPHRINE BITARTRATE, which is a drug marketed by Amneal, Anthea Pharma, Aspiro, Baxter Hlthcare Corp, Biocon Pharma, Breckenridge, Caplin, Fresenius Kabi Usa, Gland, Hikma, Meitheal, Metrics Pharm, Mylan Labs Ltd, Rising, Sandoz, Sun Pharm, Zydus Pharms, Inforlife, Long Grove Pharms, and Sagent, and is included in twenty-two NDAs. It is available from twenty-one suppliers. There are thirteen 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-four suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.

Summary for 219924

Tradename:	NOREPINEPHRINE BITARTRATE
Applicant:	Anthea Pharma
Ingredient:	norepinephrine bitartrate
Patents:	0

Pharmacology for NDA: 219924

Medical Subject Heading (MeSH) Categories for 219924

Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents

Suppliers and Packaging for NDA: 219924

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NOREPINEPHRINE BITARTRATE	norepinephrine bitartrate	INJECTABLE;INJECTION	219924	ANDA	Anthea Pharma Private Limited	83854-017	83854-017-10	10 VIAL in 1 CARTON (83854-017-10) / 4 mL in 1 VIAL (83854-017-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/ML
Approval Date:	Nov 25, 2025	TE:	AP	RLD:	No

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