Details for New Drug Application (NDA): 021248
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NDA 021248 describes TRISENOX, which is a drug marketed by Cephalon and is included in one NDA. It is available from one supplier. Additional details are available on the TRISENOX profile page.
The generic ingredient in TRISENOX is arsenic trioxide. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the arsenic trioxide profile page.
The generic ingredient in TRISENOX is arsenic trioxide. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the arsenic trioxide profile page.
Summary for 021248
| Tradename: | TRISENOX |
| Applicant: | Cephalon |
| Ingredient: | arsenic trioxide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021248
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248 | NDA | Cephalon, LLC | 63459-601 | 63459-601-06 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63459-601-06) / 6 mL in 1 VIAL, SINGLE-DOSE (63459-601-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Sep 25, 2000 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 12, 2025 | ||||||||
| Regulatory Exclusivity Use: | ARSENIC TRIOXIDE FOR USE IN COMBINATION WITH TRETINOIN FOR TREATMENT OF ADULTS WITH NEWLY-DIAGNOSED LOW-RISK ACUTE PROMYELOCYTIC LEUKEMIA (APL) WHOSE APL IS CHARACTERIZED BY THE PRESENCE OF THE T(15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE EXPRESSION | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
| Approval Date: | Oct 13, 2017 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jan 12, 2025 | ||||||||
| Regulatory Exclusivity Use: | ARSENIC TRIOXIDE FOR USE IN COMBINATION WITH TRETINOIN FOR TREATMENT OF ADULTS WITH NEWLY-DIAGNOSED LOW-RISK ACUTE PROMYELOCYTIC LEUKEMIA (APL) WHOSE APL IS CHARACTERIZED BY THE PRESENCE OF THE T(15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE EXPRESSION | ||||||||
Expired US Patents for NDA 021248
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-002 | Oct 13, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-001 | Sep 25, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-001 | Sep 25, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-001 | Sep 25, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-002 | Oct 13, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-002 | Oct 13, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Cephalon | TRISENOX | arsenic trioxide | INJECTABLE;INJECTION | 021248-002 | Oct 13, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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