Aminophylline

ANDA 87601, held by Hospira. Aminophylline.

As of Nov 15, 2026, ANDA 87601 (Aminophylline), held by Hospira, was first approved by FDA on Jul 23, 1982, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 23, 1982
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jul 23, 1982	Original application	Approved	None posted

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 11Manufacturing	Approved	None posted
Dec 31, 1996	Supplement 10Labeling	Approved	None posted
Oct 29, 1992	Supplement 8Manufacturing	Approved	None posted
Oct 29, 1992	Supplement 9Manufacturing	Approved	None posted
Apr 13, 1990	Supplement 7Labeling	Approved	None posted
Jan 3, 1990	Supplement 6Labeling	Approved	None posted
Apr 1, 1988	Supplement 5Manufacturing	Approved	None posted
May 10, 1983	Supplement 1Manufacturing	Approved	None posted
Jul 23, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87601
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