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Details for New Drug Application (NDA): 206356

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NDA 206356 describes ORFADIN, which is a drug marketed by Swedish Orphan and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ORFADIN profile page.

The generic ingredient in ORFADIN is nitisinone. One supplier is listed for this compound. Additional details are available on the nitisinone profile page.

Summary for NDA: 206356

Tradename:
ORFADIN
Applicant:
Swedish Orphan
Ingredient:
nitisinone
Patents:1
Therapeutic Class:Enzyme Replacements/Modifiers

Pharmacology for NDA: 206356

Suppliers and Packaging for NDA: 206356

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORFADIN
nitisinone
SUSPENSION;ORAL 206356 NDA Swedish Orphan Biovitrum AB (publ) 66658-204 66658-204-90 1 BOTTLE, GLASS in 1 CARTON (66658-204-90) > 90 mL in 1 BOTTLE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength4MG/ML
Approval Date:Apr 22, 2016TE:RLD:Yes
Patent:9,301,932Patent Expiration:Feb 28, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HEREDITARY TYROSINEMIA TYPE 1 (HT-1) IN COMBINATION WITH DIETARY RESTRICTION OF TYROSINE AND PHENYLALANIE


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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