General MedicationsINJECTIONStandard
ARGATROBAN
ARGATROBAN
Standard Dose
250MG/2.5ML (100MG/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 206698 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ARGATROBAN Form and strength INJECTABLE;INJECTION - 250MG/2.5ML (100MG/ML) Sponsor AMNEAL PHARMS CO Submission history Latest submission status date: 2018-01-26 00:00:00.
Structured Monograph
Clinical summary
Approval overview ARGATROBAN is listed in Drugs@FDA under application 206698 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ARGATROBAN Form and strength INJECTABLE;INJECTION - 250MG/2.5ML (100MG/ML) Sponsor AMNEAL PHARMS CO Submission history Latest submission status date: 2018-01-26 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.