Truphylline

ANDA 85498, held by Cosette Pharms Nc. Aminophylline.

As of Nov 15, 2026, ANDA 85498 (Truphylline), held by Cosette Pharms Nc, was first approved by FDA on Jan 3, 1983, with 9 approved supplements and 0 published complete response letters.

First approved: Jan 3, 1983
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jan 3, 1983	Original application	Approved	None posted

Products

2 strengths and forms


Truphylline250MG · suppository;rectal	Aminophylline	Discontinued
Truphylline500MG · suppository;rectal	Aminophylline	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Oct 14, 1997	Supplement 14Labeling	Approved	None posted
May 1, 1992	Supplement 13Labeling	Approved	None posted
Jul 15, 1991	Supplement 12Labeling	Approved	None posted
Jun 18, 1990	Supplement 11Labeling	Approved	None posted
Dec 29, 1988	Supplement 10Labeling	Approved	None posted
Nov 5, 1985	Supplement 8Manufacturing	Approved	None posted
May 27, 1983	Supplement 5Manufacturing	Approved	None posted
Mar 22, 1983	Supplement 1Manufacturing	Approved	None posted
Mar 22, 1983	Supplement 2Manufacturing	Approved	None posted
Jan 3, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 85498
Drugs@FDA: Overview at FDA
Company: Cosette Pharmaceuticals

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