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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 211304

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NDA 211304 describes METARAMINOL BITARTRATE, which is a drug marketed by Abraxis Pharm, Azurity, Elkins Sinn, Fresenius Kabi Usa, and Gd Searle Llc, and is included in five NDAs. Additional details are available on the METARAMINOL BITARTRATE profile page.

The generic ingredient in METARAMINOL BITARTRATE is metaraminol bitartrate. There is one drug master file entry for this compound. Additional details are available on the metaraminol bitartrate profile page.

Summary for 211304

Tradename:	METARAMINOL BITARTRATE
Applicant:	Azurity
Ingredient:	metaraminol bitartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 211304

Adrenergic alpha-1 Receptor Agonists
Sympathomimetics
Vasoconstrictor Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML
Approval Date:	Aug 24, 2021	TE:		RLD:	No

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