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General MedicationsINJECTIONStandard

DOCETAXEL

DOCETAXEL

Standard Dose
80MG/8ML (10MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DOCETAXEL is listed in Drugs@FDA under application 215744 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DOCETAXEL Form and strength INJECTABLE;INJECTION - 80MG/8ML (10MG/ML) Sponsor ALEMBIC Submission history Latest submission status date: 2023-07-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview DOCETAXEL is listed in Drugs@FDA under application 215744 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DOCETAXEL Form and strength INJECTABLE;INJECTION - 80MG/8ML (10MG/ML) Sponsor ALEMBIC Submission history Latest submission status date: 2023-07-12 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.