Azmiro

NDA 216318, held by Azurity. Testosterone Cypionate.

As of Nov 15, 2026, NDA 216318 (Azmiro), held by Azurity, was first approved by FDA on Jun 2, 2022, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 2, 2022
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

AZMIRO is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone:

Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchiectomy, Klinefelter’s syndrome, or toxic damage from alcohol or heavy metals, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 2, 2022	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Azmiro200MG/ML (200MG/ML) · solution;intramuscular	Testosterone Cypionate	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Jul 11, 2025	Supplement 5Labeling · Standard review	Approved	Letter Label Medication Guide
Dec 18, 2024	Supplement 3Labeling · Standard review	Approved	Label Letter
Feb 1, 2024	Supplement 2Labeling · Standard review	Approved	Label Letter
Jun 2, 2022	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 216318
Drugs@FDA: Overview at FDA
Company: Azurity 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