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NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUNNY · Approved 2018-05-24

Drug application

FDA Application #

ANDA208516

Application type

Abbreviated New Drug Application (Generic)

Brand name

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

Generic name

NITROFURANTOIN

Active ingredients

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

SUNNY

Manufacturer

Trigen Laboratories, LLC

First approval

2018-05-24

Source

Authoritative

Drugs@FDA application overview

Machine

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