Ertugliflozin

ANDA 216947, held by Aurobindo Pharma Ltd. Ertugliflozin.

As of Nov 15, 2026, ANDA 216947 (Ertugliflozin), held by Aurobindo Pharma Ltd, was first approved by FDA on Jul 13, 2023, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 13, 2023
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
Jul 13, 2023	Original application	Approved	Letter

Products

2 strengths and forms


Ertugliflozin5MG · tablet;oral	Ertugliflozin	Discontinued
Ertugliflozin15MG · tablet;oral	Ertugliflozin	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Dec 3, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Dec 9, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Jul 11, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Jul 13, 2023	Original application	Approved	Letter

Identifiers

Application: ANDA 216947
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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