Aminophylline

ANDA 81142, held by Teva Parenteral. Aminophylline.

As of Nov 15, 2026, ANDA 81142 (Aminophylline), held by Teva Parenteral, was first approved by FDA on Sep 25, 1991, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 25, 1991
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Sep 25, 1991	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Jun 2, 1995	Supplement 1Manufacturing	Approved	None posted
Sep 25, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 81142
Drugs@FDA: Overview at FDA
Company: Teva Parenteral Medicines

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