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FDA ANDA · ANDA211013

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

Sponsor: INVENTIA

APPLICATION
ANDA211013
TYPE
ANDA
ORIGINAL APPROVAL
2022-02-18
LATEST ACTION
2024-06-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2024-06-20Manufacturing (CMC) · Supplement 4 · unknownAP
2024-04-12Labeling · Supplement 2 · standardAP
2022-02-18UNKNOWN · 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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