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FDA ANDA · ANDA215002

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

Sponsor: ALVOGEN

APPLICATION
ANDA215002
TYPE
ANDA
ORIGINAL APPROVAL
2022-07-20
LATEST ACTION
2022-07-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2022-07-20UNKNOWN · Original · standardAP
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