Details for New Drug Application (NDA): 200153
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The generic ingredient in LIPTRUZET is atorvastatin calcium; ezetimibe. There are sixty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atorvastatin calcium; ezetimibe profile page.
Summary for 200153
Tradename: | LIPTRUZET |
Applicant: | Organon |
Ingredient: | atorvastatin calcium; ezetimibe |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | May 3, 2013 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | May 3, 2013 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | May 3, 2013 | TE: | RLD: | Yes |
Expired US Patents for NDA 200153
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-004 | May 3, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-004 | May 3, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Organon | LIPTRUZET | atorvastatin calcium; ezetimibe | TABLET;ORAL | 200153-003 | May 3, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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