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Details for New Drug Application (NDA): 209449
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NDA 209449 describes NITYR, which is a drug marketed by Cycle Pharms Ltd and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the NITYR profile page.
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.
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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