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General MedicationsINTRAVENOUS, SUBCUTANEOUSGeneric

OMONTYS

PEGINESATIDE ACETATE

Standard Dose
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview OMONTYS is listed in Drugs@FDA under application 202799 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient PEGINESATIDE ACETATE Form and strength SOLUTION;INTRAVENOUS, SUBCUTANEOUS - EQ 20MG BASE/2ML (EQ 10MG BASE/ML) Sponsor TAKEDA PHARMS USA Submission history Latest submission status date: 2012-12-04 00:00:00.

Structured Monograph

Clinical summary

Approval overview OMONTYS is listed in Drugs@FDA under application 202799 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient PEGINESATIDE ACETATE Form and strength SOLUTION;INTRAVENOUS, SUBCUTANEOUS - EQ 20MG BASE/2ML (EQ 10MG BASE/ML) Sponsor TAKEDA PHARMS USA Submission history Latest submission status date: 2012-12-04 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.