Aminophylline

ANDA 87209, held by Intl Medication. Aminophylline.

As of Nov 15, 2026, ANDA 87209 (Aminophylline), held by Intl Medication, was first approved by FDA on Feb 1, 1982, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 1, 1982
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 1, 1982	Original application	Approved	None posted

Products

1 strengths and forms

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

All 6 submissions, including labeling and manufacturing supplements


Sep 19, 1995	Supplement 12Manufacturing	Approved	None posted
Jun 17, 1994	Supplement 11Manufacturing	Approved	None posted
Mar 26, 1991	Supplement 6Labeling	Approved	None posted
May 1, 1987	Supplement 4Manufacturing	Approved	None posted
Dec 4, 1986	Supplement 3Manufacturing	Approved	None posted
Feb 1, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87209
Drugs@FDA: Overview at FDA
Company: International Medication Systems

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