Aminophylline

ANDA 87431, held by Lyphomed. Aminophylline.

As of Nov 15, 2026, ANDA 87431 (Aminophylline), held by Lyphomed, was first approved by FDA on Nov 10, 1981, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 10, 1981
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
Nov 10, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminophylline25MG/ML · injectable;injection	Aminophylline	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Feb 26, 1990	Supplement 24Labeling	Approved	None posted
Oct 30, 1989	Supplement 20Labeling	Approved	None posted
Nov 10, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87431
Drugs@FDA: Overview at FDA
Company: Lyphomed

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