KISQALI is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Ribociclib.
Product ID | 0078-0860_0ef16a12-43a8-4956-b1c1-07877366d919 |
NDC | 0078-0860 |
Product Type | Human Prescription Drug |
Proprietary Name | KISQALI |
Generic Name | Ribociclib |
Dosage Form | Tablet, Film Coated |
Route of Administration | ORAL |
Marketing Start Date | 2017-03-13 |
Marketing Category | NDA / NDA |
Application Number | NDA209092 |
Labeler Name | Novartis Pharmaceuticals Corporation |
Substance Name | RIBOCICLIB |
Active Ingredient Strength | 200 mg/1 |
Pharm Classes | Kinase Inhibitor [EPC],Kinase Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2017-03-13 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA209092 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2017-03-13 |
Ingredient | Strength |
---|---|
RIBOCICLIB | 200 mg/1 |
SPL SET ID: | aaeaef94-f3f5-4367-8ea2-b181d7be2da8 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
0078-0860 | KISQALI | ribociclib |
0078-0867 | KISQALI | ribociclib |
0078-0874 | KISQALI | ribociclib |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
KISQALI 79156360 4820261 Live/Registered |
NOVARTIS AG 2014-10-02 |