Aminophylline

ANDA 87239, held by Elkins Sinn. Aminophylline.

As of Nov 15, 2026, ANDA 87239 (Aminophylline), held by Elkins Sinn, was first approved by FDA on Feb 11, 1981, with 10 approved supplements and 0 published complete response letters.

First approved: Feb 11, 1981
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Feb 11, 1981	Original application	Approved	None posted

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements


Sep 29, 1992	Supplement 14Manufacturing	Approved	None posted
Mar 29, 1991	Supplement 13Labeling	Approved	None posted
Jan 31, 1991	Supplement 12Labeling	Approved	None posted
Feb 9, 1989	Supplement 11Manufacturing	Approved	None posted
Feb 9, 1989	Supplement 10Manufacturing	Approved	None posted
Jun 8, 1987	Supplement 8Manufacturing	Approved	None posted
Mar 25, 1987	Supplement 7Manufacturing	Approved	None posted
Nov 3, 1986	Supplement 6Manufacturing	Approved	None posted
Nov 18, 1985	Supplement 5Manufacturing	Approved	None posted
Feb 14, 1983	Supplement 2Manufacturing	Approved	None posted
Feb 11, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87239
Drugs@FDA: Overview at FDA
Company: Elkins-Sinn

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