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FDA Drug Approval, N200153, LIPTRUZET
FDA Drug Approval, N200153, LIPTRUZET
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NDA: 200153
Company: ORGANON
Drug Name: LIPTRUZET
Active Ingredients: ATORVASTATIN CALCIUM; EZETIMIBE
Strength: EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: TABLET;ORAL
Action Date: 05/03/2013
Marketing Status: Discontinued
Submission Classification: Type 2 New Active Ingredient and Type 4 New Combination
Company: ORGANON
Drug Name: LIPTRUZET
Active Ingredients: ATORVASTATIN CALCIUM; EZETIMIBE
Strength: EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: TABLET;ORAL
Action Date: 05/03/2013
Marketing Status: Discontinued
Submission Classification: Type 2 New Active Ingredient and Type 4 New Combination
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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