Aminophylline

ANDA 87600, held by Am Regent. Aminophylline.

As of Nov 15, 2026, ANDA 87600 (Aminophylline), held by Am Regent, was first approved by FDA on Aug 27, 1981, with 19 approved supplements and 0 published complete response letters.

First approved: Aug 27, 1981
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Aug 27, 1981	Original application	Approved	None posted

Products

1 strengths and forms

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

All 20 submissions, including labeling and manufacturing supplements


May 16, 2023	Supplement 28Manufacturing	Approved	None posted
Aug 23, 2002	Supplement 21Manufacturing	Approved	None posted
Aug 23, 2002	Supplement 22Manufacturing	Approved	None posted
Nov 14, 1997	Supplement 19Manufacturing	Approved	None posted
Oct 1, 1997	Supplement 20Labeling	Approved	None posted
Oct 3, 1996	Supplement 18Labeling	Approved	None posted
Feb 28, 1996	Supplement 17Manufacturing	Approved	None posted
Dec 14, 1994	Supplement 16Labeling	Approved	None posted
Mar 4, 1994	Supplement 15Labeling	Approved	None posted
Jan 9, 1991	Supplement 13Manufacturing	Approved	None posted
Jun 19, 1990	Supplement 14Labeling	Approved	None posted
Mar 7, 1989	Supplement 10Manufacturing	Approved	None posted
Mar 7, 1989	Supplement 11Manufacturing	Approved	None posted
Mar 7, 1989	Supplement 12Manufacturing	Approved	None posted
Jun 15, 1987	Supplement 6Manufacturing	Approved	None posted
Jun 15, 1987	Supplement 7Manufacturing	Approved	None posted
Jun 15, 1987	Supplement 8Manufacturing	Approved	None posted
Jun 15, 1987	Supplement 9Manufacturing	Approved	None posted
Sep 20, 1982	Supplement 1Manufacturing	Approved	None posted
Aug 27, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87600
Drugs@FDA: Overview at FDA
Company: Am Regent

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