General MedicationsTRANSDERMALStandard
TESTOSTERONE
TESTOSTERONE
Standard Dose
25MG/2.5GM PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview TESTOSTERONE is listed in Drugs@FDA under application 212984 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TESTOSTERONE Form and strength GEL;TRANSDERMAL - 25MG/2.5GM PACKET Sponsor ENCUBE Submission history Latest submission status date: 2025-12-17 00:00:00.
Structured Monograph
Clinical summary
Approval overview TESTOSTERONE is listed in Drugs@FDA under application 212984 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TESTOSTERONE Form and strength GEL;TRANSDERMAL - 25MG/2.5GM PACKET Sponsor ENCUBE Submission history Latest submission status date: 2025-12-17 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.