Details for New Drug Application (NDA): 209449
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NDA 209449 describes NITYR, which is a drug marketed by Cycle 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 is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
The generic ingredient in NITYR is nitisinone. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
Summary for 209449
| Tradename: | NITYR |
| Applicant: | Cycle |
| Ingredient: | nitisinone |
| Patents: | 1 |
Suppliers and Packaging for NDA: 209449
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HARLIKU | 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 |
| HARLIKU | 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: | 10,328,029 | Patent Expiration: | Jan 5, 2035 | 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 | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jul 26, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 10,328,029 | Patent Expiration: | Jan 5, 2035 | 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 | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 26, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 10,328,029 | Patent Expiration: | Jan 5, 2035 | 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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