General MedicationsORALStandard

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Standard Dose

75MG;25MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: UNKNOWN Marketing status: Prescription

Summary

Approval overview NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) is listed in Drugs@FDA under application 217357 (ANDA).

Review priority: UNKNOWN Marketing status: Prescription Active ingredient NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE Form and strength CAPSULE;ORAL - 75MG;25MG Sponsor MANKIND PHARMA Submission history Latest submission status date: 2025-03-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) is listed in Drugs@FDA under application 217357 (ANDA). Review priority: UNKNOWN Marketing status: Prescription Active ingredient NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE Form and strength CAPSULE;ORAL - 75MG;25MG Sponsor MANKIND PHARMA Submission history Latest submission status date: 2025-03-21 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: UNKNOWN

Interaction Notes

No interaction notes stored yet.