Budesonide

ANDA 207367, held by Rising. Budesonide.

As of Nov 15, 2026, ANDA 207367 (Budesonide), held by Rising, was first approved by FDA on Apr 7, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 7, 2017
Review: Standard
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 7, 2017	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Jan 26, 2026	Supplement 13Labeling · Standard review	Approved	None posted
Oct 23, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Nov 15, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Apr 7, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 207367
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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