APPLICATION
ANDA217272
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-21
LATEST ACTION
2025-03-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 50MG · CAPSULE · ORAL
NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 100MG · CAPSULE · ORAL
NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 25MG · CAPSULE · ORAL
Approval history
2025-03-21Manufacturing (CMC) · Supplement 4 · unknownAP
2023-03-21UNKNOWN · Original · standardAP
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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