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Details for New Drug Application (NDA): 209449
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The generic ingredient in NITYR is nitisinone. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
Summary for 209449
Tradename: | NITYR |
Applicant: | Cycle Pharms Ltd |
Ingredient: | nitisinone |
Patents: | 1 |
Pharmacology for NDA: 209449
Mechanism of Action | Hydroxyphenylpyruvate Dioxygenase Inhibitors Cytochrome P450 2C9 Inhibitors |
Suppliers and Packaging for NDA: 209449
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NITYR | nitisinone | TABLET;ORAL | 209449 | NDA | Cycle Pharmaceuticals Ltd. | 70709-000 | 70709-000-60 | 1 BOTTLE, PLASTIC in 1 CARTON (70709-000-60) > 60 TABLET in 1 BOTTLE, PLASTIC |
NITYR | nitisinone | TABLET;ORAL | 209449 | NDA | Cycle Pharmaceuticals Ltd. | 70709-002 | 70709-002-60 | 1 BOTTLE, PLASTIC in 1 CARTON (70709-002-60) > 60 TABLET in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Jul 26, 2017 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Jan 5, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jul 26, 2017 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Jan 5, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jul 26, 2017 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Jan 5, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? |
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