Dutasteride

ANDA 202530, held by Rising. Dutasteride.

As of Nov 15, 2026, ANDA 202530 (Dutasteride), held by Rising, was first approved by FDA on Nov 20, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 20, 2015
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 20, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dutasteride0.5MG · capsule;oral	Dutasteride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 12, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Nov 20, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 202530
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