NDC 70661-003

ROSZET

(rosuvastatin And Ezetimibe)

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 ID70661-003_7601cebd-392a-416f-af77-efcebd8173d4
NDC70661-003
Product TypeHuman Prescription Drug
Proprietary NameROSZET
Generic Name(rosuvastatin And Ezetimibe)
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2021-05-10
Marketing CategoryNDA /
Application NumberNDA213072
Labeler NameAlthera Pharmaceuticals LLC
Substance NameROSUVASTATIN CALCIUM; EZETIMIBE
Active Ingredient Strength21 mg/1; mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA],Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70661-003-30

30 TABLET in 1 BOTTLE (70661-003-30)
Marketing Start Date2021-05-10
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "ROSZET" or generic name "(rosuvastatin And Ezetimibe)"

NDCBrand NameGeneric Name
70661-001ROSZET(rosuvastatin and ezetimibe)
70661-002ROSZET(rosuvastatin and ezetimibe)
70661-003ROSZET(rosuvastatin and ezetimibe)
70661-004ROSZET(rosuvastatin and ezetimibe)

Trademark Results [ROSZET]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ROSZET
ROSZET
88699868 not registered Live/Pending
Marie Dias
2019-11-20
ROSZET
ROSZET
86904772 not registered Dead/Abandoned
DIAS, MARIE
2016-02-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.