NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

Post-LOE

nitrofurantoin (monohydrate/macrocrystals)

Aurobindo Pharma

ANDAORALCAPSULE

Approved

Jul 2023

Lifecycle

Post-LOE

Competitive Pressure

30/100

Data completeness

3/8 — Basic

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (nitrofurantoin (monohydrate/macrocrystals)) by Aurobindo Pharma is clinical pharmacology each nitrofurantoin capsule (monohydrate/macrocrystals) contains two forms of nitrofurantoin. Approved for pyelonephritis, perinephric abscesses. First approved in 2023.

Drug data last refreshed 1w ago

Mechanism of Action

CLINICAL PHARMACOLOGY Each nitrofurantoin capsule (monohydrate/macrocrystals) contains two forms of nitrofurantoin. Twenty-five percent is macrocrystalline nitrofurantoin, which has slower dissolution and absorption than nitrofurantoin monohydrate. The remaining 75% is nitrofurantoin monohydrate…

Pharmacologic Class:

Nitrofuran Antibacterial

Indications (2)

pyelonephritis

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.