Aminophylline

ANDA 88182, held by Duramed Pharms Barr. Aminophylline.

As of Nov 15, 2026, ANDA 88182 (Aminophylline), held by Duramed Pharms Barr, was first approved by FDA on Mar 31, 1983, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 31, 1983
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 31, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminophylline100MG · tablet;oral	Aminophylline	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Aug 8, 1990	Supplement 12Labeling	Approved	None posted
Mar 15, 1989	Supplement 10Labeling	Approved	None posted
Mar 31, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88182
Drugs@FDA: Overview at FDA
Company: Duramed Pharmaceuticals (Barr)

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