Dilor-400

ANDA 84751, held by Savage Labs. Dyphylline.

As of Nov 14, 2026, ANDA 84751 (Dilor-400), held by Savage Labs, was first approved by FDA on Aug 16, 1976, with 8 approved supplements and 0 published complete response letters.

First approved: Aug 16, 1976
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dilor-400400MG · tablet;oral	Dyphylline	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Dec 15, 1995	Supplement 26Manufacturing	Approved	None posted
Mar 4, 1993	Supplement 25Manufacturing	Approved	None posted
Sep 10, 1991	Supplement 24Manufacturing	Approved	None posted
Apr 2, 1990	Supplement 23Manufacturing	Approved	None posted
Nov 28, 1988	Supplement 22Manufacturing	Approved	None posted
Nov 28, 1988	Supplement 21Manufacturing	Approved	None posted
Jan 13, 1983	Supplement 20Manufacturing	Approved	None posted
Jan 13, 1983	Supplement 19Manufacturing	Approved	None posted
Aug 16, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 84751
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