FDA.reportPublic FDA data

Testozole

Manufacturer
Advanced Pharmaceutical Technology, Inc.
Effective date
2021-12-21
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:21:49

Label at a glance#

ProductTestozole
Active ingredientTESTOSTERONE, ANASTROZOLE
Label structure6 sections

Storage and handling

Store t controlled room temperature

Label contents#

Full prescribing information#

Indication:

INDICATIONS & USAGE SECTION

Estrogen Receptor Positive Metastatic Breast Cancer

Usual Dosage:

DOSAGE & ADMINISTRATION SECTION

180mg Testosterone & 12mg of Anastrozole

CAUTION:

SPL UNCLASSIFIED SECTION

Federal Law prohibits dispensing without prescription.

Storage:

STORAGE AND HANDLING SECTION

Store t controlled room temperature

Manufactured by:

SPL UNCLASSIFIED SECTION

ADVANCED PHARMACEUTICAL TECHNOLOGY

Phone: (914)358-5260

Elmsford, NY 10523

Testozole (57377-660-01)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TestozoleTestozole

SPL UNCLASSIFIED SECTION

Testozole

HOW SUPPLIED SECTION

3 Sterile Pellets

DOSAGE FORMS & STRENGTHS SECTION

For subcutaneous implantation

Each pellet contains:

60mg Testosterone

4mg Anastrozole

Caution:

SAFE HANDLING WARNING SECTION

Federal Law prohibits dispensing without presciption.

STORAGE AND HANDLING SECTION

Store at controlled room temperature.

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57377-66057377-660-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONEFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT
TESTOSTERONE3XMK78S47OACTIB
ANASTROZOLE2Z07MYW1AZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d3c401da-adba-3ba8-e053-2995a90a20d5d3b0a32e-1026-07b4-e053-2a95a90a805e2021-12-22Exact identifier
spl set id: d3b0a32e-1026-07b4-e053-2a95a90a805e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.