Didanosine

ANDA 77167, held by Barr. Didanosine.

As of Nov 15, 2026, ANDA 77167 (Didanosine), held by Barr, was first approved by FDA on Dec 3, 2004, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 3, 2004
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
Dec 3, 2004	Original application	Approved	Letter

Products

3 strengths and forms


Didanosine200MG · capsule, delayed rel pellets;oral	Didanosine	Discontinued
Didanosine250MG · capsule, delayed rel pellets;oral	Didanosine	Discontinued
Didanosine400MG · capsule, delayed rel pellets;oral	Didanosine	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Feb 10, 2012	Supplement 7Labeling	Approved	None posted
Mar 22, 2010	Supplement 5Labeling	Approved	None posted
Jan 29, 2010	Supplement 4Labeling	Approved	None posted
Dec 3, 2004	Original application	Approved	Letter

Identifiers

Application: ANDA 77167
Drugs@FDA: Overview at FDA
Company: Barr 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