Aminophylline

ANDA 88126, held by Roxane. Aminophylline.

As of Nov 15, 2026, ANDA 88126 (Aminophylline), held by Roxane, was first approved by FDA on Aug 19, 1983, with 15 approved supplements and 0 published complete response letters.

First approved: Aug 19, 1983
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Aug 19, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminophylline105MG/5ML · solution;oral	Aminophylline	Discontinued

All 16 submissions, including labeling and manufacturing supplements


Feb 17, 1999	Supplement 17Manufacturing	Approved	None posted
Feb 17, 1999	Supplement 13Manufacturing	Approved	None posted
Nov 16, 1998	Supplement 15Manufacturing	Approved	None posted
Aug 31, 1998	Supplement 16Labeling	Approved	None posted
Aug 28, 1996	Supplement 9Manufacturing	Approved	None posted
Aug 15, 1996	Supplement 12Labeling	Approved	None posted
Aug 1, 1996	Supplement 11Manufacturing	Approved	None posted
Aug 26, 1992	Supplement 8Labeling	Approved	None posted
Oct 3, 1990	Supplement 7Labeling	Approved	None posted
Apr 6, 1990	Supplement 5Manufacturing	Approved	None posted
Mar 22, 1990	Supplement 6Labeling	Approved	None posted
Jun 22, 1989	Supplement 2Labeling	Approved	None posted
Jul 18, 1988	Supplement 4Manufacturing	Approved	None posted
Jul 18, 1988	Supplement 3Manufacturing	Approved	None posted
Oct 24, 1984	Supplement 1Manufacturing	Approved	None posted
Aug 19, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88126
Drugs@FDA: Overview at FDA
Company: Roxane Laboratories

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