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Medicines · US (FDA)
Sex hormones and modulators

FDA 1983

3-oxoandrosten (4) derivatives

Testosterone

Approved 23 Aug 1983InjectionInjectable

The FDA lists this product in 39 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: TESTOSTERONE 50MG/ML

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

TESTOSTERONE 50MG/ML · InjectableThis page
TESTOSTERONE 30MG/1.5ML ACTUATION · Solution, meteredANDA209533-001 · Prescription
TESTOSTERONE 30MG/1.5ML ACTUATION · Solution, meteredANDA212301-001 · Discontinued
TESTOSTERONE 50MG/5GM PACKET · GelANDA076737-002 · Prescription
TESTOSTERONE 12.5MG/1.25GM ACTUATION · Gel, meteredANDA076737-003 · Prescription
TESTOSTERONE 25MG/2.5GM PACKET · GelANDA076737-001 · Prescription
TESTOSTERONE 25MG/ML · InjectableANDA086420-001 · Discontinued
TESTOSTERONE 50MG/5GM PACKET · GelANDA076744-002 · Prescription
TESTOSTERONE 25MG/2.5GM PACKET · GelANDA076744-001 · Prescription
TESTOSTERONE 100MG/ML · InjectableANDA086417-001 · Discontinued
TESTOSTERONE 30MG/1.5ML ACTUATION · Solution, meteredANDA204255-001 · Prescription

More in sex hormones and modulators

Conjugated Estrogensestrogens, conjugated · Tablet
EnzalutamideTablet

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

TESTOSTERONE 25MG/2.5GM PACKET · GelANDA212984-003 · Prescription

TESTOSTERONE 50MG/5GM PACKET · GelANDA212984-001 · Prescription

TESTOSTERONE 12.5MG/1.25GM ACTUATION · Gel, meteredANDA212984-002 · Prescription

TESTOSTERONE 25MG/2.5GM PACKET · GelNDA202763-001 · Discontinued

TESTOSTERONE 50MG/5GM PACKET · GelNDA202763-002 · Discontinued

TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) · GelANDA205781-002 · Prescription

TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) · GelANDA205781-001 · Prescription

TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) · Gel, meteredANDA207373-001 · Prescription

TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) · Gel, meteredANDA209390-001 · Discontinued

TESTOSTERONE 10MG/0.5GM ACTUATION · Gel, meteredANDA204571-001 · Prescription

TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) · Gel, meteredANDA213922-001 · Discontinued

TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) · Gel, meteredANDA204268-001 · Prescription

TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) · Gel, meteredANDA204570-001 · Prescription

TESTOSTERONE 1.62% (20.25MG/1.25GM PACKET) · GelANDA204570-002 · Prescription

TESTOSTERONE 1.62% (40.5MG/2.5GM PACKET) · GelANDA204570-003 · Prescription

TESTOSTERONE 30MG/1.5ML ACTUATION · Solution, meteredANDA208061-001 · Prescription

TESTOSTERONE 30MG/1.5ML ACTUATION · Solution, meteredANDA209836-001 · Discontinued

TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) · Gel, meteredANDA210835-001 · Prescription

TESTOSTERONE 30MG/1.5ML ACTUATION · Solution, meteredANDA207337-001 · Tentative approval

TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) · Gel, meteredANDA208620-001 · Prescription

TESTOSTERONE 30MG/1.5ML ACTUATION · Solution, meteredANDA212882-001 · Discontinued

TESTOSTERONE 30MG/1.5ML ACTUATION · Solution, meteredANDA205328-001 · Prescription

TESTOSTERONE 1.62% (20.25MG/1.25GM ACTUATION) · Gel, meteredANDA208560-001 · Prescription

TESTOSTERONE 30MG/1.5ML ACTUATION · Solution, meteredANDA209181-001 · Discontinued

TESTOSTERONE 50MG/5GM PACKET · GelANDA091073-001 · Prescription

TESTOSTERONE 50MG/5GM PACKET · GelNDA203098-003 · Discontinued

TESTOSTERONE 12.5MG/1.25GM ACTUATION · Gel, meteredNDA203098-001 · Discontinued

TESTOSTERONE 25MG/2.5GM PACKET · GelNDA203098-002 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA086419.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Testosterone
Drug class: 3-oxoandrosten (4) derivatives, Androgens and estrogens
Group: Sex hormones and modulators
Route: Injection
Dosage form: Injectable
Applicant: Watson Labs
Status: Discontinued
FDA approval: 23 Aug 1983
Application: ANDA086419-001
RxCUI: 10379

Guidelines

Guidelines in obstetrics and gynaecology1,051 guidelines in the library

FDA 2024

Femlyvethinyl estradiol · Tablet, orally disintegrating

FDA 2024EstradiolGel, metered

FDA 2024OspemifeneTablet

FDA 2023Enilloringethinyl estradiol · Ring

FDA 2023Orserduelacestrant hydrochloride · Tablet

FDA 2023Emzahhnorethindrone · Tablet

FDA 2022Haloetteethinyl estradiol · Ring

FDA 2021Veraringethinyl estradiol · Ring

FDA 2021Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarateethinyl estradiol · Capsule

FDA 2021Ethinyl Estradiol and Norelgestrominethinyl estradiol · Film, extended release

FDA 2021Ethinyl Estradiol; Etonogestrelethinyl estradiol · Ring

FDA 2020Dolishaleethinyl estradiol · Tablet

FDA 2020Winleviclascoterone · Cream

FDA 2020Xtandienzalutamide · Tablet

FDA 2020Finzalaethinyl estradiol · Tablet

FDA 2020Twirlaethinyl estradiol · System