NITISINONE

2 FDA products 2 manufacturers ORAL

NITISINONE is an active ingredient listed in 2 FDA drug label records from 2 manufacturers taken by oral route marketed mainly as human prescription drug products.

About NITISINONE

NITISINONE appears as the active ingredient in 2 FDA drug label records. These products are produced by 2 distinct manufacturers, with the largest catalogues from Par Health USA, LLC, SWEDISH ORPHAN BIOVITRUM AB (PUBL). In this ingredient’s product set, the most common route of administration is oral. Approved labelling for these products most frequently references: treatment adult, pediatric patients, hereditary tyrosinemia, type ht-, dietary restriction, hydroxy-phenylpyruvate dioxygenase, inhibitor indicated, indications usage. Every record below is taken from FDA Structured Product Labelling data; use it to compare brand names, strengths and manufacturers before speaking with a pharmacist.

How it is supplied

Dosage formProductsRouteProducts
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Main manufacturers

ManufacturerProductsMarketing type
Par Health USA, LLC 1 HUMAN PRESCRIPTION DRUG
SWEDISH ORPHAN BIOVITRUM AB (PUBL) 1 HUMAN PRESCRIPTION DRUG

FDA drug products containing NITISINONE

Brand nameManufacturerTypeRouteDosage form
Nitisinone Par Health USA, LLC HUMAN PRESCRIPTION DRUG ORAL
Orfadin SWEDISH ORPHAN BIOVITRUM AB (PUBL) HUMAN PRESCRIPTION DRUG ORAL

Frequently asked questions

How many FDA drug products contain NITISINONE?
2 FDA drug label records list NITISINONE as the active ingredient, supplied by 2 manufacturers. The table below lists the brand names, manufacturers and dosage forms covered by those labels.

Which companies make NITISINONE products?
The manufacturers with the most NITISINONE label records are Par Health USA, LLC, SWEDISH ORPHAN BIOVITRUM AB (PUBL). Generic and brand versions may be produced by different companies.

Is this a substitute for medical advice?
No. This page reproduces FDA labelling data so you can identify a product and its manufacturer. Dosing, interactions and suitability must be confirmed with a prescriber or pharmacist.

This page reproduces FDA Structured Product Labelling data for identification purposes. It is not medical advice and does not recommend, sell or price any medicine.