General MedicationsINTRAVENOUS, INTRAVENOUSStandard

NITHIODOTE

SODIUM NITRITE; SODIUM THIOSULFATE

Standard Dose

300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview NITHIODOTE is listed in Drugs@FDA under application 201444 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SODIUM NITRITE; SODIUM THIOSULFATE Form and strength SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS - 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML) Sponsor HOPE PHARMS Submission history Latest submission status date: 2021-01-13 00:00:00.

Structured Monograph

Clinical summary

Approval overview NITHIODOTE is listed in Drugs@FDA under application 201444 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SODIUM NITRITE; SODIUM THIOSULFATE Form and strength SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS - 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML) Sponsor HOPE PHARMS Submission history Latest submission status date: 2021-01-13 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.