Dutasteride

ANDA 207935, held by Heritage Pharms Inc. Dutasteride.

As of Nov 15, 2026, ANDA 207935 (Dutasteride), held by Heritage Pharms Inc, was first approved by FDA on Oct 13, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 13, 2017
Review: Standard
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
Oct 13, 2017	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 25, 2026	Supplement 1Labeling · Standard review	Approved	None posted
Oct 13, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 207935
Drugs@FDA: Overview at FDA
Company: Heritage 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