APPLICATION
ANDA203233
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-09
LATEST ACTION
2025-02-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 50MG · CAPSULE · ORAL
NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 100MG · CAPSULE · ORAL
Approval history
2025-02-18Labeling · Supplement 5 · standardAP
2018-07-09UNKNOWN · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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