Didanosine

ANDA 90788, held by Pharmobedient. Didanosine.

As of Nov 15, 2026, ANDA 90788 (Didanosine), held by Pharmobedient, was first approved by FDA on Apr 8, 2010, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 8, 2010
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
Apr 8, 2010	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 4 submissions, including labeling and manufacturing supplements


Dec 6, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Apr 8, 2010	Original application	Approved	Letter

Identifiers

Application: ANDA 90788
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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