Aminophylline In Sodium Chloride 0.45%

ANDA 88147, held by Hospira. Aminophylline.

As of Nov 15, 2026, ANDA 88147 (Aminophylline In Sodium Chloride 0.45%), held by Hospira, was first approved by FDA on May 3, 1983, with 3 approved supplements and 0 published complete response letters.

First approved: May 3, 1983
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

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

Products

2 strengths and forms


Aminophylline In Sodium Chloride 0.45%100MG/100ML · injectable;injection	Aminophylline	Discontinued
Aminophylline In Sodium Chloride 0.45%200MG/100ML · injectable;injection	Aminophylline	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Sep 20, 1996	Supplement 4Manufacturing	Approved	None posted
Apr 28, 1989	Supplement 3Labeling	Approved	None posted
Nov 15, 1984	Supplement 1Manufacturing	Approved	None posted
May 3, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 88147
Drugs@FDA: Overview at FDA
Company: Hospira

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