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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 083363

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NDA 083363 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 083363

Tradename:	METARAMINOL BITARTRATE
Applicant:	Elkins Sinn
Ingredient:	metaraminol bitartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 083363

Adrenergic alpha-1 Receptor Agonists
Sympathomimetics
Vasoconstrictor Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10MG BASE/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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