Didanosine

ANDA 78112, held by Aurobindo Pharma. Didanosine.

As of Nov 15, 2026, ANDA 78112 (Didanosine), held by Aurobindo Pharma, was first approved by FDA on Mar 8, 2007, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 8, 2007
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
Mar 8, 2007	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Didanosine10MG/ML · for solution;oral	Didanosine	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jan 31, 2012	Supplement 4Labeling	Approved	None posted
Dec 27, 2011	Supplement 3Labeling	Approved	None posted
Mar 29, 2010	Supplement 2Labeling	Approved	None posted
Mar 8, 2007	Original application	Approved	Letter

Identifiers

Application: ANDA 78112
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