Dilor

ANDA 84514, held by Savage Labs. Dyphylline.

As of Nov 14, 2026, ANDA 84514 (Dilor), held by Savage Labs, was first approved by FDA on Aug 16, 1976, with 10 approved supplements and 0 published complete response letters.

First approved: Aug 16, 1976
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Aug 16, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dilor200MG · tablet;oral	Dyphylline	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Feb 22, 1996	Supplement 27Manufacturing	Approved	None posted
Mar 4, 1993	Supplement 26Manufacturing	Approved	None posted
Feb 10, 1992	Supplement 25Manufacturing	Approved	None posted
Feb 10, 1992	Supplement 24Manufacturing	Approved	None posted
Feb 10, 1992	Supplement 23Manufacturing	Approved	None posted
Nov 25, 1988	Supplement 22Manufacturing	Approved	None posted
Nov 25, 1988	Supplement 21Manufacturing	Approved	None posted
Jan 13, 1983	Supplement 19Manufacturing	Approved	None posted
Jan 13, 1983	Supplement 18Manufacturing	Approved	None posted
Nov 3, 1981	Supplement 3Manufacturing	Approved	None posted
Aug 16, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 84514
Drugs@FDA: Overview at FDA
Company: Savage Laboratories

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