Details for New Drug Application (NDA): 203469
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NDA 203469 describes ICLUSIG, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ICLUSIG profile page.
The generic ingredient in ICLUSIG is ponatinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.
The generic ingredient in ICLUSIG is ponatinib hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ponatinib hydrochloride profile page.
Summary for 203469
| Tradename: | ICLUSIG |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | ponatinib hydrochloride |
| Patents: | 6 |
Pharmacology for NDA: 203469
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 203469
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ICLUSIG | ponatinib hydrochloride | TABLET;ORAL | 203469 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-533 | 63020-533-30 | 30 TABLET, FILM COATED in 1 BOTTLE (63020-533-30) |
| ICLUSIG | ponatinib hydrochloride | TABLET;ORAL | 203469 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-534 | 63020-534-30 | 30 TABLET, FILM COATED in 1 BOTTLE (63020-534-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 15MG BASE | ||||
| Approval Date: | Dec 14, 2012 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 19, 2031 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ ALL) | ||||||||
| Regulatory Exclusivity Expiration: | Mar 19, 2027 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ ALL) IN COMBINATION WITH CHEMOTHERAPY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 12, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA | ||||||||
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