Atazanavir Sulfate

ANDA 200626, held by Cipla. Atazanavir Sulfate.

As of Nov 15, 2026, ANDA 200626 (Atazanavir Sulfate), held by Cipla, was first approved by FDA on Aug 9, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 9, 2018
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 9, 2018	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 4 submissions, including labeling and manufacturing supplements


Jul 17, 2025	Supplement 6Labeling · Standard review	Approved	None posted
Nov 22, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Aug 7, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Aug 9, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 200626
Drugs@FDA: Overview at FDA
Company: Cipla

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