Aramine

NDA 9509, held by Merck. Metaraminol Bitartrate.

As of Nov 13, 2026, NDA 9509 (Aramine), held by Merck, was first approved by FDA on Sep 29, 1954, with 15 approved supplements and 0 published complete response letters.

First approved: Sep 29, 1954
Review: Priority
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Sep 29, 1954	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
AramineEQ 10MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Metaraminol Bitartrate	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 21, 2001	Supplement 26Manufacturing · Priority review	Approved	Label
Feb 19, 1998	Supplement 25Manufacturing · Priority review	Approved	None posted
Jan 9, 1998	Supplement 24Manufacturing · Priority review	Approved	None posted
Jan 9, 1998	Supplement 23Manufacturing · Priority review	Approved	None posted
Dec 5, 1995	Supplement 22Manufacturing · Priority review	Approved	None posted
Jan 15, 1992	Supplement 21Manufacturing · Priority review	Approved	None posted
Dec 22, 1987	Supplement 19Labeling · Priority review	Approved	None posted
Dec 22, 1987	Supplement 15Labeling · Priority review	Approved	None posted
Aug 27, 1985	Supplement 17Manufacturing · Priority review	Approved	None posted
Oct 11, 1984	Supplement 16Manufacturing · Priority review	Approved	None posted
Oct 22, 1982	Supplement 14Manufacturing · Priority review	Approved	None posted
Nov 3, 1981	Supplement 12Manufacturing · Priority review	Approved	None posted
Jul 14, 1981	Supplement 13Manufacturing · Priority review	Approved	None posted
Feb 5, 1980	Supplement 11Manufacturing · Priority review	Approved	None posted
Oct 30, 1978	Supplement 10Labeling · Priority review	Approved	None posted
Sep 29, 1954	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 9509
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters