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General MedicationsINTRAMUSCULARGeneric

TESTOSTERONE UNDECANOATE

TESTOSTERONE UNDECANOATE

Standard Dose
750MG/3ML (250MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview TESTOSTERONE UNDECANOATE is listed in Drugs@FDA under application 207583 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient TESTOSTERONE UNDECANOATE Form and strength INJECTABLE;INTRAMUSCULAR - 750MG/3ML (250MG/ML) Sponsor HIKMA PHARMACEUTICALS USA INC Submission history Latest submission status date: 2016-12-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview TESTOSTERONE UNDECANOATE is listed in Drugs@FDA under application 207583 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient TESTOSTERONE UNDECANOATE Form and strength INJECTABLE;INTRAMUSCULAR - 750MG/3ML (250MG/ML) Sponsor HIKMA PHARMACEUTICALS USA INC Submission history Latest submission status date: 2016-12-09 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.