Dutasteride

ANDA 202204, held by Hikma. Dutasteride.

As of Nov 15, 2026, ANDA 202204 (Dutasteride), held by Hikma, was first approved by FDA on Nov 23, 2015, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 23, 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 23, 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 4, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Nov 23, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 202204
Drugs@FDA: Overview at FDA
Company: Hikma

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