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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 216341

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NDA 216341 describes NOREPINEPHRINE BITARTRATE, which is a drug marketed by Amneal, 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-one NDAs. It is available from twenty 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-three suppliers are listed for this compound. Additional details are available on the norepinephrine bitartrate profile page.

Summary for 216341

Tradename:	NOREPINEPHRINE BITARTRATE
Applicant:	Zydus Pharms
Ingredient:	norepinephrine bitartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 216341

Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1MG BASE/ML
Approval Date:	Jul 19, 2022	TE:		RLD:	No

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