Budesonide

ANDA 90410, held by Aurobindo Pharma USA. Budesonide.

As of Nov 15, 2026, ANDA 90410 (Budesonide), held by Aurobindo Pharma USA, was first approved by FDA on May 16, 2011, with 5 approved supplements and 0 published complete response letters.

First approved: May 16, 2011
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 16, 2011	Original application	Approved	Review Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Budesonide3MG · capsule, delayed release;oral	Budesonide	Rx

All 6 submissions, including labeling and manufacturing supplements


Jul 29, 2021	Supplement 9Labeling · Standard review	Approved	None posted
Jul 29, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Jul 29, 2021	Supplement 12Labeling · Standard review	Approved	None posted
Jul 29, 2021	Supplement 15Manufacturing	Approved	None posted
Jan 3, 2016	Supplement 7Labeling · Standard review	Approved	None posted
May 16, 2011	Original application	Approved	Review Review

Identifiers

Application: ANDA 90410
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma USA

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