← FDA Drug Approvals (Drugs@FDA)

NITISINONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MEDUNIK · Approved 2022-05-26

Drug application

FDA Application #

ANDA212390

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

MEDUNIK

Manufacturer

Analog Pharma

First approval

2022-05-26

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown