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General MedicationsINJECTIONStandard

ARGATROBAN

ARGATROBAN

Standard Dose
50MG/50ML (1MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ARGATROBAN is listed in Drugs@FDA under application 217848 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ARGATROBAN Form and strength INJECTABLE;INJECTION - 50MG/50ML (1MG/ML) Sponsor GLAND Submission history Latest submission status date: 2023-07-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview ARGATROBAN is listed in Drugs@FDA under application 217848 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ARGATROBAN Form and strength INJECTABLE;INJECTION - 50MG/50ML (1MG/ML) Sponsor GLAND Submission history Latest submission status date: 2023-07-31 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.