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General MedicationsTRANSDERMALStandard

TESTOSTERONE

TESTOSTERONE

Standard Dose
50MG/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 - 50MG/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 - 50MG/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.