Atazanavir Sulfate

ANDA 209717, held by Amneal. Atazanavir Sulfate.

As of Nov 15, 2026, ANDA 209717 (Atazanavir Sulfate), held by Amneal, was first approved by FDA on Jun 1, 2020, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 1, 2020
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 1, 2020	Original application	Approved	None posted

Products

4 strengths and forms


Atazanavir SulfateEQ 100MG BASE · capsule;oral	Atazanavir Sulfate	Discontinued
Atazanavir SulfateEQ 150MG BASE · capsule;oral	Atazanavir Sulfate	Discontinued
Atazanavir SulfateEQ 200MG BASE · capsule;oral	Atazanavir Sulfate	Discontinued
Atazanavir SulfateEQ 300MG BASE · capsule;oral	Atazanavir Sulfate	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Aug 12, 2025	Supplement 7Labeling · Standard review	Approved	None posted
Aug 12, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Aug 12, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Mar 26, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Jun 1, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 209717
Drugs@FDA: Overview at FDA
Company: Amneal 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