Details for New Drug Application (NDA): 213072
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The generic ingredient in ROSZET is ezetimibe; rosuvastatin calcium. There are twenty-four drug master file entries for this compound. Additional details are available on the ezetimibe; rosuvastatin calcium profile page.
Summary for 213072
Tradename: | ROSZET |
Applicant: | Althera Pharms |
Ingredient: | ezetimibe; rosuvastatin calcium |
Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213072
Generic Entry Date for 213072*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG;EQ 5MG BASE | ||||
Approval Date: | Mar 23, 2021 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 1, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF HYPERLIPIDEMIA | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 1, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF HYPERLIPIDEMIA |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG;EQ 10MG BASE | ||||
Approval Date: | Mar 23, 2021 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 1, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF HYPERLIPIDEMIA |
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