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NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CREEKWOOD PHARMS · Approved 2026-04-07

Drug application

FDA Application #
ANDA220269
Application type
Abbreviated New Drug Application (Generic)
Brand name
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Generic name
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Active ingredients
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
CREEKWOOD PHARMS
Manufacturer
Creekwood Pharmaceuticals LLC
First approval
2026-04-07

Source

Authoritative
Drugs@FDA application overview
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