Phyllocontin

ANDA 86760, held by Pharm Res Assoc. Aminophylline.

As of Nov 15, 2026, ANDA 86760 (Phyllocontin), held by Pharm Res Assoc, was first approved by FDA on Nov 21, 1979, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 21, 1979
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
Nov 21, 1979	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phyllocontin225MG · tablet, extended release;oral	Aminophylline	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Mar 3, 1997	Supplement 12Labeling	Approved	None posted
Mar 6, 1996	Supplement 11Labeling	Approved	None posted
Aug 16, 1991	Supplement 6Labeling	Approved	None posted
Nov 21, 1979	Original application	Approved	None posted

Identifiers

Application: ANDA 86760
Drugs@FDA: Overview at FDA
Company: Pharmaceutical Research Associates

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