Iclusig is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Ponatinib Hydrochloride.
| Product ID | 63020-536_568f48fb-4038-429a-8d32-0e6a8b833638 |
| NDC | 63020-536 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Iclusig |
| Generic Name | Ponatinib Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-01-11 |
| Marketing Category | NDA / NDA |
| Application Number | NDA203469 |
| Labeler Name | Takeda Pharmaceuticals America, Inc. |
| Substance Name | PONATINIB HYDROCHLORIDE |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2021-01-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 63020-533 | Iclusig | ponatinib hydrochloride |
| 63020-534 | Iclusig | ponatinib hydrochloride |
| 63020-535 | Iclusig | ponatinib hydrochloride |
| 63020-536 | Iclusig | ponatinib hydrochloride |
| 76189-533 | Iclusig | ponatinib hydrochloride |
| 76189-534 | Iclusig | ponatinib hydrochloride |
| 76189-535 | Iclusig | ponatinib hydrochloride |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ICLUSIG 85254659 4324899 Live/Registered |
ARIAD Pharmaceuticals, Inc. 2011-03-01 |