Didanosine

ANDA 90094, held by Aurobindo Pharma. Didanosine.

As of Nov 15, 2026, ANDA 90094 (Didanosine), held by Aurobindo Pharma, was first approved by FDA on Sep 24, 2008, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 24, 2008
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Sep 24, 2008	Original application	Approved	Letter

Products

4 strengths and forms


Didanosine125MG · capsule, delayed rel pellets;oral	Didanosine	Discontinued
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 8 submissions, including labeling and manufacturing supplements


Nov 14, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Nov 14, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Jan 31, 2012	Supplement 9Labeling	Approved	None posted
Dec 27, 2011	Supplement 8Labeling	Approved	None posted
Mar 22, 2010	Supplement 6Labeling	Approved	None posted
Sep 2, 2009	Supplement 5Labeling	Approved	None posted
Nov 14, 2008	Supplement 1Labeling	Approved	None posted
Sep 24, 2008	Original application	Approved	Letter

Identifiers

Application: ANDA 90094
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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