ROSZET is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Althera Pharmaceuticals Llc. The primary component is Rosuvastatin Calcium; Ezetimibe.
Product ID | 70661-004_7601cebd-392a-416f-af77-efcebd8173d4 |
NDC | 70661-004 |
Product Type | Human Prescription Drug |
Proprietary Name | ROSZET |
Generic Name | (rosuvastatin And Ezetimibe) |
Dosage Form | Tablet |
Route of Administration | ORAL |
Marketing Start Date | 2021-05-10 |
Marketing Category | NDA / |
Application Number | NDA213072 |
Labeler Name | Althera Pharmaceuticals LLC |
Substance Name | ROSUVASTATIN CALCIUM; EZETIMIBE |
Active Ingredient Strength | 42 mg/1; mg/1 |
Pharm Classes | HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2022-12-31 |
Marketing Start Date | 2021-05-10 |
NDC Exclude Flag | N |
Sample Package? | N |
NDC | Brand Name | Generic Name |
---|---|---|
70661-001 | ROSZET | (rosuvastatin and ezetimibe) |
70661-002 | ROSZET | (rosuvastatin and ezetimibe) |
70661-003 | ROSZET | (rosuvastatin and ezetimibe) |
70661-004 | ROSZET | (rosuvastatin and ezetimibe) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ROSZET 88699868 not registered Live/Pending |
Marie Dias 2019-11-20 |
ROSZET 86904772 not registered Dead/Abandoned |
DIAS, MARIE 2016-02-11 |