Fulvestrant

ANDA 205871, held by Sagent Pharms Inc. Fulvestrant.

As of Nov 14, 2026, ANDA 205871 (Fulvestrant), held by Sagent Pharms Inc, was first approved by FDA on Aug 22, 2019, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 22, 2019
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
Aug 22, 2019	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fulvestrant250MG/5ML (50MG/ML) · solution;intramuscular	Fulvestrant	Rx

All 4 submissions, including labeling and manufacturing supplements


May 15, 2023	Supplement 6Labeling · Standard review	Approved	None posted
May 15, 2023	Supplement 9Labeling · Standard review	Approved	None posted
May 15, 2023	Supplement 10Labeling · Standard review	Approved	None posted
Aug 22, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 205871
Drugs@FDA: Overview at FDA
Company: Sagent 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