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 |