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. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
The generic ingredient in ORFADIN is nitisinone. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
Summary for 206356
| Tradename: | ORFADIN |
| Applicant: | Swedish Orphan |
| Ingredient: | nitisinone |
| Patents: | 1 |
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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 4MG/ML | ||||
| Approval Date: | Apr 22, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 9,301,932 | Patent Expiration: | Feb 28, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HEREDITARY TYROSINEMIA TYPE 1 (HT-1) IN COMBINATION WITH DIETARY RESTRICTION OF TYROSINE AND PHENYLALANINE | ||||||||
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