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MACROBID

NDA · New Drug Application · Sponsor: ALMATICA · Approved 1991-12-24

Drug application

FDA Application #

NDA020064

Application type

New Drug Application

Brand name

MACROBID

Generic name

NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE

Active ingredients

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

ALMATICA

Manufacturer

Alvogen Inc.

First approval

1991-12-24

Source

Authoritative

Drugs@FDA application overview

Machine

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