Aminophyllin

NDA 2386, held by Gd Searle LLC. Aminophylline.

As of Nov 13, 2026, NDA 2386 (Aminophyllin), held by Gd Searle LLC, was first approved by FDA on Apr 19, 1940, with 15 approved supplements and 0 published complete response letters.

First approved: Apr 19, 1940
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Apr 19, 1940	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Aminophyllin100MG · tablet;oral	Aminophylline	Discontinued
Aminophyllin200MG · tablet;oral	Aminophylline	Discontinued

All 16 submissions, including labeling and manufacturing supplements


Aug 27, 1991	Supplement 12Labeling · Standard review	Approved	None posted
Aug 27, 1991	Supplement 13Labeling · Standard review	Approved	None posted
Aug 27, 1991	Supplement 15Labeling · Standard review	Approved	None posted
Aug 14, 1989	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 9, 1983	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 14, 1981	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 14, 1981	Supplement 10Labeling · Standard review	Approved	None posted
Sep 15, 1980	Supplement 5Labeling · Standard review	Approved	None posted
Jun 13, 1980	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 13, 1980	Supplement 7Manufacturing · Standard review	Approved	None posted
May 23, 1980	Supplement 8Labeling · Standard review	Approved	None posted
Jan 18, 1980	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 1, 1977	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 1, 1977	Supplement 2Labeling · Standard review	Approved	None posted
Aug 1, 1977	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 19, 1940	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 2386
Drugs@FDA: Overview at FDA
Company: G.D. Searle

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