Is Testosterone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Testosterone, including Androgel (16.2 mg/g, Gel, SAR 205.15); Axelus (200 mg/ml, Solution for injection, SAR 26.25); TESTAVAN (20 mg/g, Gel, SAR 213.00); TESTOVIRON DEPOT 250MG-1ML AMP (250 mg/ml, Solution for injection, SAR 26.25).

Is Testosterone approved by the US FDA?

Drugs@FDA lists 86 application product lines for Testosterone, including TESTOPEL (Prescription); DEPO-TESTOSTERONE (Prescription); ANDROGEL (Prescription); ANDROGEL (Prescription); TESTIM (Prescription).

Is Testosterone authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Testosterone.

Is Testosterone on the WHO Model List of Essential Medicines?

Yes — 18.2. Androgens (complementary list): Testicular dysfunction or testosterone-related disorders.

Are there safety signals or safety updates for Testosterone?

EMA PRAC: 1 entry; US FDA: 14 entries (latest 2025-07-11).

Active substance

Testosterone

SFDA 5
US FDA 86
EMA 2
Health Canada 9
US price lines 19
NHS prices 5
WHO EML 1
Safety 15

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Androgel	16.2 mg/g	Gel · Transdermal use	1 Tube	SAR 205.15	NCE · Prescription	Laboratoires Besins International	Valid
Axelus	200 mg/ml	Solution for injection · Intramuscular use	1 Vial	SAR 26.25	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
TESTAVAN	20 mg/g	Gel · Transdermal use	1 Spray Pump	SAR 213.00	NCE · Prescription	Ferring GmbH	Valid
TESTOVIRON DEPOT 250MG-1ML AMP	250 mg/ml	Solution for injection · Intramuscular use	1 Ampoule	SAR 26.25	NCE · Prescription	BAYER PHARMA AG	Valid
ANDROGEL 1% GEL	1 %	Gel · Topical	30 Sachet	SAR 232.65	NCE · Prescription	ABBOTT PRODUCTS GMBH	Invalid · Not Marketed

Indications — CHI Daman Drug Formulary

DUCHENNE MUSCULAR DYSTROPHY

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
TESTOPEL	75MG	pellet · implantation	ENDO OPERATIONS	Prescription	13 Jul 1972
DEPO-TESTOSTERONE	100MG/ML; 200MG/ML	injectable · injection	PFIZER	Prescription	25 Jul 1979
ANDROGEL	25MG/2.5GM PACKET; 50MG/5GM PACKET	gel · transdermal	BESINS HLTHCARE	Prescription	28 Feb 2000
ANDROGEL	12.5MG/1.25GM ACTUATION	gel, metered · transdermal	BESINS HLTHCARE	Prescription	28 Feb 2000
TESTIM	50MG/5GM PACKET	gel · transdermal	ENDO OPERATIONS	Prescription	31 Oct 2002
TESTOSTERONE CYPIONATE	200MG/ML	injectable · injection	PADAGIS US	Prescription	31 Jan 2005
TESTOSTERONE	25MG/2.5GM PACKET; 50MG/5GM PACKET	gel · transdermal	ACTAVIS LABS UT INC	Prescription	27 Jan 2006
TESTOSTERONE	12.5MG/1.25GM ACTUATION	gel, metered · transdermal	ACTAVIS LABS UT INC	Prescription	27 Jan 2006
TESTOSTERONE ENANTHATE	200MG/ML	injectable · injection	NEXUS	Prescription	14 Jun 2006
TESTOSTERONE	25MG/2.5GM PACKET; 50MG/5GM PACKET	gel · transdermal	STRIDES PHARMA INTL	Prescription	23 May 2007
TESTOSTERONE CYPIONATE	100MG/ML; 200MG/ML	injectable · injection	HIKMA PHARMS	Prescription	15 Jul 2010
ANDROGEL	1.62% (20.25MG/1.25GM ACTUATION)	gel, metered · transdermal	BESINS HLTHCARE	Prescription	29 Apr 2011
ANDROGEL	1.62% (20.25MG/1.25GM PACKET); 1.62% (40.5MG/2.5GM PACKET)	gel · transdermal	BESINS HLTHCARE	Prescription	29 Apr 2011
TESTOSTERONE CYPIONATE	200MG/ML	injectable · injection	HIKMA FARMACEUTICA	Prescription	1 May 2012
TESTOSTERONE ENANTHATE	200MG/ML	injectable · injection	HIKMA FARMACEUTICA	Prescription	18 Sep 2012
NATESTO	5.5MG/0.122GM ACTUATION	gel, metered · nasal	ACERUS	Prescription	28 May 2014
VOGELXO	50MG/5GM PACKET	gel · transdermal	UPSHER SMITH LABS	Prescription	4 Jun 2014
VOGELXO	12.5MG/1.25GM ACTUATION	gel, metered · transdermal	UPSHER SMITH LABS	Prescription	4 Jun 2014
TESTOSTERONE	1.62% (20.25MG/1.25GM ACTUATION)	gel, metered · transdermal	PADAGIS ISRAEL	Prescription	4 Aug 2015
TESTOSTERONE	10MG/0.5GM ACTUATION	gel, metered · transdermal	ACTAVIS LABS UT INC	Prescription	5 Aug 2015
TESTOSTERONE	30MG/1.5ML ACTUATION	solution, metered · transdermal	PADAGIS ISRAEL	Prescription	28 Feb 2017
TESTOSTERONE CYPIONATE	200MG/ML	injectable · injection	AM REGENT	Prescription	16 Jun 2017
TESTOSTERONE	1.62% (20.25MG/1.25GM PACKET); 1.62% (40.5MG/2.5GM PACKET)	gel · transdermal	PADAGIS ISRAEL	Prescription	12 Jul 2017
TESTOSTERONE	30MG/1.5ML ACTUATION	solution, metered · transdermal	ACTAVIS LABS UT INC	Prescription	7 Aug 2017
TESTOSTERONE	50MG/5GM PACKET	gel · transdermal	ACTAVIS LABS UT INC	Prescription	18 Sep 2017

61 more — full table

EMA European Union — centrally authorised medicines

Livensa Warner Chilcott Deutschland GmbH · Withdrawn · authorised 28 Jul 2006 · ATC G03BA03

Therapeutic indication (EMA)

Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.

Intrinsa Warner Chilcott UK Ltd. · Withdrawn · authorised 28 Jul 2006 · ATC G03BA03

Therapeutic indication (EMA)

Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ANDROGEL	02245345	1 %	GEL · TRANSDERMAL	BGP PHARMA ULC
ANDROGEL	02245346	1 %	GEL · TRANSDERMAL	BGP PHARMA ULC
ANDROGEL	02249499	12.5 MG / ACT	GEL · TRANSDERMAL	BGP PHARMA ULC
NATESTO	02450550	4.5 % / W/W	GEL · NASAL	ACERUS BIOPHARMA INC
TARO-TESTOSTERONE CYPIONATE INJECTION	02496003	100 MG / ML	SOLUTION · INTRAMUSCULAR	TARO PHARMACEUTICALS INC
TARO-TESTOSTERONE GEL	02463792	1 %	GEL · TRANSDERMAL	TARO PHARMACEUTICALS INC
TARO-TESTOSTERONE GEL	02463806	1 %	GEL · TRANSDERMAL	TARO PHARMACEUTICALS INC
TESTIM 1%	02280248	1 %	GEL · TRANSDERMAL	KNIGHT THERAPEUTICS INC.
TESTOSTERONE ENANTHATE INJECTION, USP	02536315	200 MG / ML	SOLUTION · INTRAMUSCULAR	HIKMA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DEPO-TESTOSTERONE 1,000 MG/10 ML	$6.91704	per ML	17 Dec 2025
US NADAC	TESTIM 1% (50 MG) GEL	$3.78468	per GM	23 Sep 2026
US NADAC	TESTOSTERONE 1% (25 MG/2.5 G) PK	$1.20385	per GM	23 Sep 2026
US NADAC	TESTOSTERONE 1% (50 MG/5 G) PK	$0.40611	per GM	23 Sep 2026
US NADAC	TESTOSTERONE 1.62% (2.5 G) PKT	$1.81823	per GM	23 Sep 2026
US NADAC	TESTOSTERONE 1.62% GEL PUMP	$0.46695	per GM	23 Sep 2026
US NADAC	TESTOSTERONE 1.62%(1.25 G) PKT	$3.64945	per GM	23 Sep 2026
US NADAC	TESTOSTERONE 10 MG GEL PUMP	$4.5465	per GM	19 Nov 2025
US NADAC	TESTOSTERONE 12.5 MG/1.25 GRAM	$0.82642	per GM	23 Sep 2026
US NADAC	TESTOSTERONE 30 MG/1.5 ML PUMP	$0.50763	per ML	23 Sep 2026
US NADAC	TESTOSTERONE 50 MG/5 GRAM GEL	$0.73654	per GM	23 Sep 2026
US NADAC	TESTOSTERONE 50 MG/5 GRAM PKT	$0.40611	per GM	23 Sep 2026
NHS Drug Tariff	Testosterone 16.2mg/g transdermal gel (20.25mg per actuation)	£39.94	88 gram	1 Oct 2026
NHS Drug Tariff	Testosterone 2% transdermal gel (10mg per actuation)	£28.63	60 gram	1 Oct 2026
NHS Drug Tariff	Testosterone 20mg/g transdermal gel (23mg per actuation) refill	£28.50	85.5 gram	1 Oct 2026
NHS Drug Tariff	Testosterone 20mg/g transdermal gel (23mg per actuation) with applicator	£28.50	85.5 gram	1 Oct 2026
NHS Drug Tariff	Testosterone 40.5mg/2.5g transdermal gel unit dose sachets	£39.94	30 sachet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

18.2. Androgens · complementary
Testicular dysfunction or testosterone-related disorders
Parenteral > General injections > IM: 200 mg per mL in 1 mL ampoule (enantate)

Safety signals and safety-related labeling changes

US FDA 11 Jul 2025 ANDROGEL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Jul 2025 ANDROGEL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Jul 2025 FORTESTA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Jul 2025 TESTIM — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Jul 2025 VOGELXO — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Jul 2025 AZMIRO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Jul 2025 NATESTO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Jul 2025 XYOSTED (AUTOINJECTOR) — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 May 2020 ANDRODERM — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations
US FDA 13 Jul 2017 AXIRON — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 25 Oct 2016 DELATESTRYL — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 25 Oct 2016 STRIANT — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 25 Oct 2016 TESTOSTERONE — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 25 Oct 2016 TESTOSTERONE — safety-related labeling change
Labeling sections changed: Warnings and Precautions
EMA PRAC 6 Mar 2014 PRAC signal: New publications suggesting the risk of cardiovascular events
Action for MAH: update of the product information: No

All safety entries for testosterone →

Combinations containing Testosterone

Testosterone + testosterone isocaproate + testosterone phenylpropionate

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.