Aminophylline

Treats acute exacerbations of the symptoms and reversible airflow obstruction associated…. ANDA 87242, held by Hospira. Aminophylline.

As of Nov 15, 2026, ANDA 87242 (Aminophylline), held by Hospira, was first approved by FDA on Oct 26, 1983, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 26, 1983
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Intravenous theophylline is indicated as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Oct 26, 1983	Original application	Approved	None posted

Products

1 strengths and forms

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

All 15 submissions, including labeling and manufacturing supplements


Jul 30, 1999	Supplement 16Manufacturing	Approved	None posted
Feb 24, 1997	Supplement 15Manufacturing	Approved	None posted
Dec 31, 1996	Supplement 13Labeling	Approved	None posted
Oct 3, 1996	Supplement 14Manufacturing	Approved	None posted
Feb 1, 1995	Supplement 5Labeling	Approved	None posted
Dec 22, 1993	Supplement 11Manufacturing	Approved	None posted
Aug 28, 1992	Supplement 10Manufacturing	Approved	None posted
Mar 5, 1992	Supplement 6Manufacturing	Approved	None posted
Mar 5, 1992	Supplement 7Manufacturing	Approved	None posted
Mar 5, 1992	Supplement 8Manufacturing	Approved	None posted
Mar 5, 1992	Supplement 9Manufacturing	Approved	None posted
Apr 9, 1991	Supplement 3Labeling	Approved	None posted
May 7, 1990	Supplement 4Labeling	Approved	None posted
Dec 27, 1989	Supplement 2Labeling	Approved	None posted
Oct 26, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 87242
Drugs@FDA: Overview at FDA
Company: Hospira

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