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General MedicationsTABLETGeneric

AZACITIDINE

AZACITIDINE

Standard Dose
300MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview AZACITIDINE is listed in Drugs@FDA under application 218751 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient AZACITIDINE Form and strength TABLET - 300MG Sponsor TEVA PHARMACEUTICALS DEVELOPMENT INC Submission history Latest submission status date: 2025-04-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview AZACITIDINE is listed in Drugs@FDA under application 218751 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient AZACITIDINE Form and strength TABLET - 300MG Sponsor TEVA PHARMACEUTICALS DEVELOPMENT INC Submission history Latest submission status date: 2025-04-10 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.