Withdrawn From Sale of Tylosterone Tablets

Documents

Comments

Key Dates

Comment Period OpensAug 19, 2025

Type	Title	Posted	Comments	Status
Notice	Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661 FR Doc: 2026-12933	Jun 26, 2026	--

Total Comments

SOLVAY PHARMACEUTICALS

TYLOSTERONE INJECTION

TYLOSTERONE TABLETS

DELADUMONE INJECTION

open

CDER