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General MedicationsORALGeneric

OSIMERTINIB MESYLATE

OSIMERTINIB MESYLATE

Standard Dose
80MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview OSIMERTINIB MESYLATE is listed in Drugs@FDA under application 214263 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient OSIMERTINIB MESYLATE Form and strength TABLET;ORAL - 80MG Sponsor ZYDUS PHARMS USA INC Submission history Latest submission status date: 2021-06-01 00:00:00.

Structured Monograph

Clinical summary

Approval overview OSIMERTINIB MESYLATE is listed in Drugs@FDA under application 214263 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient OSIMERTINIB MESYLATE Form and strength TABLET;ORAL - 80MG Sponsor ZYDUS PHARMS USA INC Submission history Latest submission status date: 2021-06-01 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.