Aminophylline

ANDA 84588, held by Chartwell Molecular. Aminophylline.

As of Nov 15, 2026, ANDA 84588 (Aminophylline), held by Chartwell Molecular, was first approved by FDA on Dec 17, 1975, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 17, 1975
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
Dec 17, 1975	Original application	Approved	None posted

Products

2 strengths and forms


Aminophylline100MG · tablet;oral	Aminophylline	Discontinued
Aminophylline200MG · tablet;oral	Aminophylline	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Apr 14, 1988	Supplement 16Labeling	Approved	None posted
Dec 17, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 84588
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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