Mounjaro (Autoinjector), Mounjaro, Mounjaro Kwikpen

For type 2 diabetes mellitus. NDA 215866, held by Eli Lilly And Co. Tirzepatide.

As of Nov 13, 2026, NDA 215866 (Mounjaro (Autoinjector), Mounjaro, Mounjaro Kwikpen), held by Eli Lilly And Co, was first approved by FDA on May 13, 2022, with 12 approved supplements and 0 published complete response letters.

First approved: May 13, 2022
Review: Priority
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

MOUNJARO is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Aug 27, 2026	Supplement 45Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Aug 27, 2026	Supplement 44Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 19, 2025	Supplement 39Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 13, 2022	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

24 strengths and forms


Mounjaro (Autoinjector)2.5MG/0.5ML (2.5MG/0.5ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro (Autoinjector)5MG/0.5ML (5MG/0.5ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro (Autoinjector)7.5MG/0.5ML (7.5MG/0.5ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro (Autoinjector)10MG/0.5ML (10MG/0.5ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro (Autoinjector)12.5MG/0.5ML (12.5MG/0.5ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro (Autoinjector)15MG/0.5ML (15MG/0.5ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro2.5MG/0.5ML (2.5MG/0.5ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro5MG/0.5ML (5MG/0.5ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro7.5MG/0.5ML (7.5MG/0.5ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro10MG/0.5ML (10MG/0.5ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro12.5MG/0.5ML (12.5MG/0.5ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro15MG/0.5ML (15MG/0.5ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro10MG/2.4ML (4.17MG/ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro20MG/2.4ML (8.33MG/ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro30MG/2.4ML (12.5MG/ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro40MG/2.4ML (16.7MG/ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro50MG/2.4ML (20.8MG/ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro60MG/2.4ML (25MG/ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro Kwikpen10MG/2.4ML (4.17MG/ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro Kwikpen20MG/2.4ML (8.33MG/ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro Kwikpen30MG/2.4ML (12.5MG/ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro Kwikpen40MG/2.4ML (16.7MG/ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro Kwikpen50MG/2.4ML (20.8MG/ML) · solution;subcutaneous	Tirzepatide	RxReference drug
Mounjaro Kwikpen60MG/2.4ML (25MG/ML) · solution;subcutaneous	Tirzepatide	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Aug 27, 2026	Supplement 45Efficacy (new indication or use) · Standard review	Approved	Label Medication Guide Letter
Aug 27, 2026	Supplement 44Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 20, 2026	Supplement 9Labeling · Standard review	Approved	Letter Letter Label Medication Guide
Jan 7, 2026	Supplement 41Manufacturing · Standard review	Approved	Letter Label Medication Guide
Dec 19, 2025	Supplement 39Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 25, 2025	Supplement 34Labeling · Standard review	Approved	Letter Label
May 28, 2025	Supplement 31Labeling · Standard review	Approved	Label Letter
Nov 1, 2024	Supplement 22Labeling	Approved	Letter Label
Nov 1, 2024	Supplement 15Labeling · Standard review	Approved	Letter Label
Nov 1, 2024	Supplement 10Labeling · Standard review	Approved	Letter Label
Jul 28, 2023	Supplement 6Labeling · Standard review	Approved	Letter Label
Jul 28, 2023	Supplement 2Labeling · Standard review	Approved	Review Letter Label
May 13, 2022	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 215866
Drugs@FDA: Overview at FDA
Company: Eli Lilly

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