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FDA ANDA · ANDA217357

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

Sponsor: MANKIND PHARMA

APPLICATION
ANDA217357
TYPE
ANDA
ORIGINAL APPROVAL
2023-07-11
LATEST ACTION
2025-03-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)Prescription
NITROFURANTOIN 75MG, NITROFURANTOIN, MACROCRYSTALLINE 25MG · CAPSULE · ORAL

Approval history

2025-03-21Manufacturing (CMC) · Supplement 5 · unknownAP
2023-07-11UNKNOWN · Original · standardAP
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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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