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FDA ANDA · ANDA211935

NITROFURANTOIN

Sponsor: ALEMBIC

APPLICATION
ANDA211935
TYPE
ANDA
ORIGINAL APPROVAL
2021-06-25
LATEST ACTION
2021-06-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 100MG · CAPSULE · ORAL
NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 25MG · CAPSULE · ORAL
NITROFURANTOINPrescription
NITROFURANTOIN, MACROCRYSTALLINE 50MG · CAPSULE · ORAL

Approval history

2021-06-25UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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