← FDA Drug Approvals (Drugs@FDA)

NITROFURANTOIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVEL LABS INC · Approved 2018-07-09

Drug application

FDA Application #

ANDA203233

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

NOVEL LABS INC

Manufacturer

Lupin Pharmaceuticals,Inc.

First approval

2018-07-09

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown