Aminophylline

ANDA 85003, held by Hikma. Aminophylline.

As of Nov 15, 2026, ANDA 85003 (Aminophylline), held by Hikma, was first approved by FDA on May 28, 1976, with 26 approved supplements and 0 published complete response letters.

First approved: May 28, 1976
Supplements approved: 26
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below

Date	Submission	Status	Documents
May 28, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminophylline200MG · tablet;oral	Aminophylline	Discontinued

All 27 submissions, including labeling and manufacturing supplements


Jul 3, 2002	Supplement 42Manufacturing	Approved	None posted
Dec 11, 2000	Supplement 41Manufacturing	Approved	None posted
Dec 11, 2000	Supplement 40Manufacturing	Approved	None posted
Jan 13, 2000	Supplement 39Manufacturing	Approved	None posted
Oct 1, 1998	Supplement 38Manufacturing	Approved	None posted
Sep 24, 1996	Supplement 37Labeling	Approved	None posted
May 26, 1995	Supplement 36Manufacturing	Approved	None posted
Jun 16, 1994	Supplement 35Manufacturing	Approved	None posted
Nov 22, 1991	Supplement 32Labeling	Approved	None posted
Nov 22, 1991	Supplement 30Manufacturing	Approved	None posted
Nov 22, 1991	Supplement 29Manufacturing	Approved	None posted
Apr 2, 1991	Supplement 33Manufacturing	Approved	None posted
Apr 2, 1991	Supplement 31Manufacturing	Approved	None posted
Oct 31, 1990	Supplement 34Labeling	Approved	None posted
Jan 27, 1989	Supplement 27Manufacturing	Approved	None posted
Jan 27, 1989	Supplement 26Labeling	Approved	None posted
Jan 27, 1989	Supplement 25Manufacturing	Approved	None posted
Jul 20, 1988	Supplement 24Manufacturing	Approved	None posted
Jul 16, 1986	Supplement 21Manufacturing	Approved	None posted
Jul 16, 1986	Supplement 20Manufacturing	Approved	None posted
Jul 16, 1986	Supplement 19Manufacturing	Approved	None posted
Mar 11, 1985	Supplement 18Manufacturing	Approved	None posted
Mar 29, 1984	Supplement 17Manufacturing	Approved	None posted
Feb 17, 1984	Supplement 15Manufacturing	Approved	None posted
Aug 10, 1983	Supplement 14Manufacturing	Approved	None posted
Dec 1, 1982	Supplement 12Manufacturing	Approved	None posted
May 28, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 85003
Drugs@FDA: Overview at FDA
Company: Hikma

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