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General MedicationsINTRAVENOUSStandard

AMMONIA N 13

AMMONIA N-13

Standard Dose
30mCi-300mCi/8ML (3.75-37.5mCi/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview AMMONIA N 13 is listed in Drugs@FDA under application 211740 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMMONIA N-13 Form and strength INJECTABLE;INTRAVENOUS - 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Sponsor UNIV WISCONSIN Submission history Latest submission status date: 2020-09-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview AMMONIA N 13 is listed in Drugs@FDA under application 211740 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMMONIA N-13 Form and strength INJECTABLE;INTRAVENOUS - 30mCi-300mCi/8ML (3.75-37.5mCi/ML) Sponsor UNIV WISCONSIN Submission history Latest submission status date: 2020-09-09 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.