← FDA Drug Approvals (Drugs@FDA)

NITROFURANTOIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA USA · Approved 2004-08-18

Drug application

FDA Application #

ANDA077025

Application type

Abbreviated New Drug Application (Generic)

Brand name

NITROFURANTOIN

Generic name

NITROFURANTOIN (MACROCRYSTALS)

Active ingredients

NITROFURANTOIN, MACROCRYSTALLINE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

AUROBINDO PHARMA USA

Manufacturer

Aurobindo Pharma Limited

First approval

2004-08-18

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown