Composition
- Active ingredients
- TESTOSTERONE UNDECANOATE 750MG/3ML (250MG/ML)
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA207583.
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 Undecanoate
- Route
- Intramuscular
- Dosage form
- Injectable
- Applicant
- Hikma Pharmaceuticals USA Inc
- Status
- Tentative approval
- FDA approval
- 9 Dec 2016
- Application
- ANDA207583-001