Choledyl SA

ANDA 87863, held by Warner Chilcott LLC. Oxtriphylline.

As of Nov 14, 2026, ANDA 87863 (Choledyl SA), held by Warner Chilcott LLC, was first approved by FDA on May 24, 1983, with 13 approved supplements and 0 published complete response letters.

First approved: May 24, 1983
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
May 24, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Choledyl SA400MG · tablet, extended release;oral	Oxtriphylline	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Jun 8, 1999	Supplement 18Manufacturing	Approved	None posted
Jun 8, 1999	Supplement 19Manufacturing	Approved	None posted
Jun 8, 1999	Supplement 20Labeling	Approved	None posted
Feb 24, 1998	Supplement 15Manufacturing	Approved	None posted
Feb 24, 1998	Supplement 16Manufacturing	Approved	None posted
Jul 19, 1993	Supplement 12Labeling	Approved	None posted
Aug 12, 1992	Supplement 11Manufacturing	Approved	None posted
Nov 5, 1991	Supplement 1Labeling	Approved	None posted
Aug 21, 1991	Supplement 7Manufacturing	Approved	None posted
Aug 21, 1991	Supplement 8Manufacturing	Approved	None posted
Aug 21, 1991	Supplement 9Manufacturing	Approved	None posted
Apr 17, 1984	Supplement 2Manufacturing	Approved	None posted
Apr 17, 1984	Supplement 3Manufacturing	Approved	None posted
May 24, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 87863
Drugs@FDA: Overview at FDA
Company: Warner Chilcott Company

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