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Details for New Drug Application (NDA): 021232
NDA 021232 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. Two 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. Two suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
Summary for 021232
| Tradename: | ORFADIN |
| Applicant: | Swedish Orphan |
| Ingredient: | nitisinone |
| Patents: | 0 |
Pharmacology for NDA: 021232
| Mechanism of Action | Hydroxyphenylpyruvate Dioxygenase Inhibitors Cytochrome P450 2C9 Inhibitors |
Suppliers and Packaging for NDA: 021232
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORFADIN | nitisinone | CAPSULE;ORAL | 021232 | NDA | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | 66658-102 | 66658-102-60 | 1 BOTTLE, PLASTIC in 1 CARTON (66658-102-60) > 60 CAPSULE in 1 BOTTLE, PLASTIC |
| ORFADIN | nitisinone | CAPSULE;ORAL | 021232 | NDA | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | 66658-105 | 66658-105-60 | 1 BOTTLE, PLASTIC in 1 CARTON (66658-105-60) > 60 CAPSULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
| Approval Date: | Jan 18, 2002 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 1, 2020 | ||||||||
| Regulatory Exclusivity Use: | ONCE-DAILY DOSING FOR PATIENTS 5 YEARS OF AGE AND OLDER WHO HAVE UNDETECTABLE SERUM AND URINE SUCCINYLACETONE CONCENTRATIONS AFTER A MINIMUM OF 4 WEEKS ON A STABLE DOSAGE OF NITISINONE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 18, 2002 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 1, 2020 | ||||||||
| Regulatory Exclusivity Use: | ONCE-DAILY DOSING FOR PATIENTS 5 YEARS OF AGE AND OLDER WHO HAVE UNDETECTABLE SERUM AND URINE SUCCINYLACETONE CONCENTRATIONS AFTER A MINIMUM OF 4 WEEKS ON A STABLE DOSAGE OF NITISINONE | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 18, 2002 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 1, 2020 | ||||||||
| Regulatory Exclusivity Use: | ONCE-DAILY DOSING FOR PATIENTS 5 YEARS OF AGE AND OLDER WHO HAVE UNDETECTABLE SERUM AND URINE SUCCINYLACETONE CONCENTRATIONS AFTER A MINIMUM OF 4 WEEKS ON A STABLE DOSAGE OF NITISINONE | ||||||||
Expired US Patents for NDA 021232
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-002 | Jan 18, 2002 | ➤ Sign Up | ➤ Sign Up |
| Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-003 | Jan 18, 2002 | ➤ Sign Up | ➤ Sign Up |
| Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-001 | Jan 18, 2002 | ➤ Sign Up | ➤ Sign Up |
| Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-003 | Jan 18, 2002 | ➤ Sign Up | ➤ Sign Up |
| Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-002 | Jan 18, 2002 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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