← FDA Drug Approvals (Drugs@FDA)

NITISINONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2019-08-26

Drug application

FDA Application #

ANDA211041

Application type

Abbreviated New Drug Application (Generic)

Brand name

NITISINONE

Generic name

NITISINONE

Active ingredients

NITISINONE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

NOVITIUM PHARMA

Manufacturer

Endo USA, Inc.

First approval

2019-08-26

Source

Authoritative

Drugs@FDA application overview

Machine

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