Somophyllin-Df

ANDA 87045, held by Fisons. Aminophylline.

As of Nov 15, 2026, ANDA 87045 (Somophyllin-Df), held by Fisons, was first approved by FDA on Sep 30, 1980, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1980
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
Sep 30, 1980	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Somophyllin-Df105MG/5ML · solution;oral	Aminophylline	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Oct 31, 1990	Supplement 15Labeling	Approved	None posted
Jul 20, 1989	Supplement 13Labeling	Approved	None posted
Sep 30, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 87045
Drugs@FDA: Overview at FDA
Company: Fisons Corp.

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