Aminophylline

ANDA 87501, held by Roxane. Aminophylline.

As of Nov 15, 2026, ANDA 87501 (Aminophylline), held by Roxane, was first approved by FDA on Feb 9, 1982, with 8 approved supplements and 0 published complete response letters.

First approved: Feb 9, 1982
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Feb 9, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aminophylline200MG · tablet;oral	Aminophylline	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Aug 28, 1996	Supplement 11Manufacturing	Approved	None posted
Aug 15, 1996	Supplement 12Labeling	Approved	None posted
Sep 11, 1995	Supplement 10Manufacturing	Approved	None posted
Sep 4, 1992	Supplement 9Labeling	Approved	None posted
Oct 3, 1990	Supplement 8Labeling	Approved	None posted
Aug 26, 1988	Supplement 6Manufacturing	Approved	None posted
Aug 26, 1988	Supplement 5Manufacturing	Approved	None posted
Dec 11, 1984	Supplement 3Manufacturing	Approved	None posted
Feb 9, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87501
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