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General MedicationsORALStandard

DIGOXIN

DIGOXIN

Standard Dose
0.05MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview DIGOXIN is listed in Drugs@FDA under application 215209 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DIGOXIN Form and strength ELIXIR;ORAL - 0.05MG/ML Sponsor AMICI PHARMA Submission history Latest submission status date: 2022-03-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview DIGOXIN is listed in Drugs@FDA under application 215209 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DIGOXIN Form and strength ELIXIR;ORAL - 0.05MG/ML Sponsor AMICI PHARMA Submission history Latest submission status date: 2022-03-11 00:00:00. Submission type: ORIG.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.