Approvals (Drugs@FDA) 89
- TESTOSTERONEFDA page
ACTAVIS LABS UT INC · TESTOSTERONE
- TESTOSTERONE PROPIONATEFDA page
LILLY · TESTOSTERONE PROPIONATE
- TESTOSTERONEFDA page
ACTAVIS LABS UT INC · TESTOSTERONE
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“testosterone” matches in 21 of 26 searchable datasets. 5 did not answer this time (Drug shortages, Device classification, PMA approvals, COVID-19 serology test evaluations, Food recalls); try again shortly.
Drugs
Orange Book 123
- TESTOSTERONEFDA page
TESTOSTERONE · 30MG/1.5ML ACTUATION · SOLUTION, METERED · TRANSDERMAL
- DELATESTRYLFDA page
TESTOSTERONE ENANTHATE · 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
- DELATESTRYLFDA page
TESTOSTERONE ENANTHATE · 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Drug labels 122
- KyzatrexFDA page
TESTOSTERONE UNDECANOATE · Marius Pharmaceuticals · ORAL
- GynobalanceFDA page
DEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONE · BioActive Nutritional, Inc. · ORAL
- Depo-TestosteroneFDA page
TESTOSTERONE CYPIONATE · Pharmacia & Upjohn Company LLC · INTRAMUSCULAR
NDC directory 285
- testosterone cypionate
BPI Labs LLC · INJECTION, SOLUTION
- testosterone cypionate
BPI Labs LLC · INJECTION, SOLUTION
- testosterone cypionate
Ajenat Pharmaceuticals LLC · INJECTION, SOLUTION
Drug recalls 25
- Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc…
Teva Pharmaceuticals USA, Inc · Defective Container - A defect in the side-seal which allows leakage of product.
- Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ, Manu…
Eugia US LLC · cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
- Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380…
Strides Pharma, Inc. · Presence of foreign substance: Presence of Benzene.
Drug adverse event reports (FAERS) 38,137
- Central serous chorioretinopathy
Drugs: TESTOSTERONE ENANTHATE, CABERGOLINE
- Eye infection
Drugs: TYMLOS, ASPIRIN;DIPYRIDAMOLE, ATORVASTATIN +7
- Sinus disorder, Sensitivity to weather change
Drugs: DUPIXENT, ANASTROZOLE, SYMBICORT +2
Devices
510(k) clearances 68
- IDS-iSYS Total TestosteroneFDA page
Immunodiagnostic Systems Limited · Clinical Chemistry
- IDS-iSYS Free TestosteroneFDA page
Immunodiagnostic Systems Limited · Clinical Chemistry
- Access TestosteroneFDA page
Beckman Coulter, Inc. · Clinical Chemistry
Establishments and listings 97
- ST AIA-PACK TESTOSTERONE, ST AIA-PACK TESTOSTERONE Calibrator Set +1
TOSOH AIA, INC. · TOYAMA, JP
- Free Testosterone ELISA
DRG INSTRUMENTS GMBH · MARBURG Hesse, DE
- ACE Calibrator (LN 06U8201), Cystatin C Calibrators (LN 06T3201) +56
ABBOTT IRELAND DIAGNOSTICS DIVISION · Longford Longford, IE
Device recalls 14
- ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AI…FDA page
Tosoh Bioscience Inc · The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could c…
- Access Testosterone assay, Catalog Number 33560FDA page
Beckman Coulter, Inc. · Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosteron…
- Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in…FDA page
DRG International, Inc. · Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results…
Device recall enforcement reports 12
- ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AI…
Tosoh Bioscience Inc · The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could c…
- Access Testosterone assay, Catalog Number 33560
Beckman Coulter, Inc. · Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosteron…
- Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in…
DRG International, Inc. · Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results…
Unique device identifiers (GUDID) 140
- CARDINAL HEALTH · AMM1956FDA page
AERO-MED, LLC · PSA and Testosterone Kit
- Elecsys Testosterone II · 09745963190FDA page
Roche Diagnostics GmbH
- IDS-iSYS Total Testosterone · N/AFDA page
IMMUNODIAGNOSTIC SYSTEMS LIMITED · The IDS-iSYS Total Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of t…
Device adverse event reports (MAUDE) 118
- ELECSYS TESTOSTERONE II ASSAY · TESTOSTERONE ASSAY
ROCHE DIAGNOSTICS · Low Test Results, Output Problem +1
- ELECSYS SHBG · TESTOSTERONE TEST SYSTEM
ROCHE DIAGNOSTICS · Low Test Results, Output Problem +1
- Elecsys Testosterone II Assay · Testosterone assay
ROCHE DIAGNOSTICS · Low Test Results, Non Reproducible Results
Cosmetics
Cosmetic adverse event reports 11
- Nair Body Cream Unspecified, Wellbutrin +4
Reactions: Blister, Nipple Blister
- Medicube Zero Exosome Shot 7.500, Testosterone +6
Reactions: Infection, Rash, Scar +1
- Dermora Foot Peel Mask, Duloxotene +10
Reactions: Burning Sensation, Pruritus, Swelling
Food
Food and supplement adverse event reports (CAERS) 147
- BIOTE HORMONAL PELLETS ESTROGEN TESTOSTERONE HORMONE PELLET THERAPY, IODINE
Vit/Min/Prot/Unconv Diet(Human/Animal) · Reactions: Thyroxine free increased, Toxic nodular goitre, Tri-iodothyronine free increased
- BURN EVOLVED SCULPTNATION, TEST BOOST MAX SCULPTNATION +1
Vit/Min/Prot/Unconv Diet(Human/Animal) · Reactions: Hepatic enzyme increased
- MEGA MEN HEALTHY TESTOSTERONE VITAPAK PROGRAM
Vit/Min/Prot/Unconv Diet(Human/Animal) · Reactions: Erectile dysfunction
Animal & veterinary
Animal drug adverse event reports 110
- MSK
Dog · Reactions: Appetite loss, Wobbliness, Unable to walk +1
- MSK
Cattle · Reactions: Death, Cough, Anorexia +4
- MSK
Cattle · Reactions: Device Defective NOS, INEFFECTIVE, WEIGHT INC, Implant, Abnormal
Tobacco
Tobacco product problem reports 1
- Electronic cigarette or vaping product (for example, E-cigarette, vape or vape pen, perso…
Numbness of tongue, Cold feet, Nasal pain +7 · No information provided
Substances & reference
Substances (GSRS) 75
- 2.ALPHA.-FLUORO-17.BETA.-HYDROXYANDROST-4-EN-3-ONE PROPIONATEFDA page
Also: 2.ALPHA.-FLUOROTESTOSTERONE PROPIONATE, ANDROST-4-EN-3-ONE, 2-FLUORO-17-(1-OXOPROPOXY)-, (2.ALPHA.,17.BETA.)-, NSC-41841 +1
- (+)-ANDROSTA-1,4-DIENE-3,17-DIONEFDA page
Also: .DELTA.1,4-ANDROSTADIENE-3,17-DIONE, 1,4-ANDROSTADIENE-3,17-DIONE, 1-DEHYDROANDROSTENEDIONE +11
- 17.BETA.-HYDROXYANDROST-4-EN-3-ONE 3-PHENYLPROPIONATEFDA page
Also: 3-OXOANDROST-4-EN-17.BETA.-YL 3-PHENYLPROPIONATE, NSC-26643, TESTOSTERONE 17-PHENYLPROPIONATE +4
UNII codes 54
All 54 in UNII codes →NDC SPL data elements 128
- Testosterone
SOLUTION · HUMAN PRESCRIPTION DRUG · ANDA212301
- Testosterone
GEL · HUMAN PRESCRIPTION DRUG · ANDA208620
- Testosterone
GEL · HUMAN PRESCRIPTION DRUG · ANDA208620
Historical FDA documents 26
- For Immediate Release: May 15, 2013
FDA NEWS RELEASE For Immediate Release: May 15, 2013 En Espafiol FDA approves new drug for advanced prostate cancer Xofigo approved three months ahead of schedule under priority review program The U.S. Food and Drug Admin…
- For Immediate Release: July 26, 2013
FDA NEWS RELEASE For Immediate Release: July 26, 2013 En Espafiol FDA warns consumers about health risks with Healthy Life Chemistry dietary supplement Laboratory tests indicate presence of anabolic steroids Today, the U…
- For Immediate Release: Aug. 31, 2012
FDA NEWS RELEASE For Immediate Release: Aug. 31, 2012 FDA approves new treatment for a type of late stage prostate cancer The U.S. Food and Drug Administration today approved Xtandi (enzalutamide) to treat men with late…
Transparency
Complete response letters 6
- Acer Therapeutics Inc. · NDA 214860
g YN U.S. FOOD & DRUG ADMINISTRATION NDA 214860 COMPLETE RESPONSE Acer Therapeutics Inc. Attention: Renée M. Carroll, MS, RAC Vice President, Head of Regulatory Affairs One Gateway Center, Suite 351…
- Marius Pharmaceuticals, LLC · NDA 213953
g YN U.S. FOOD & DRUG ADMINISTRATION NDA 213953 COMPLETE RESPONSE Marius Pharmaceuticals, LLC Attention: Om Dhingra, CEO 8601 Six Forks Road, Suite 630 Raleigh, NC 27615 Dear Mr. Dhingra: Please refe…
- Clarus Therapeutics, Inc. · NDA 206089
suing, ey i St DEPARTMENT OF HEALTH AND HUMAN SERVICES aaa Food and Drug Administration Silver Spring MD 20993 NDA 206089 COMPLETE RESPONSE Clarus Therapeutics, Inc. Attention: Robert E. Dudley, Ph.D…
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