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General MedicationsINTRAMUSCULARStandard

FULVESTRANT

FULVESTRANT

Standard Dose
250MG/5ML (50MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview FULVESTRANT is listed in Drugs@FDA under application 215234 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient FULVESTRANT Form and strength SOLUTION;INTRAMUSCULAR - 250MG/5ML (50MG/ML) Sponsor ZYDUS PHARMS Submission history Latest submission status date: 2021-07-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview FULVESTRANT is listed in Drugs@FDA under application 215234 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FULVESTRANT Form and strength SOLUTION;INTRAMUSCULAR - 250MG/5ML (50MG/ML) Sponsor ZYDUS PHARMS Submission history Latest submission status date: 2021-07-29 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.