Aminophylline

ANDA 84674, held by Halsey. Aminophylline.

As of Nov 15, 2026, ANDA 84674 (Aminophylline), held by Halsey, was first approved by FDA on Jun 15, 1976, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 15, 1976
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 15, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminophylline100MG · tablet;oral	Aminophylline	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Apr 9, 1991	Supplement 23Labeling	Approved	None posted
Nov 17, 1988	Supplement 21Labeling	Approved	None posted
Jun 15, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 84674
Drugs@FDA: Overview at FDA
Company: Halsey Drug Co.

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