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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203858

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JUXTAPID (LOMITAPIDE MESYLATE)
EQ 5MG BASE
Marketing Status: Prescription
Active Ingredient: LOMITAPIDE MESYLATE
Proprietary Name: JUXTAPID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203858
Product Number: 001
Approval Date: Dec 21, 2012
Applicant Holder Full Name: CHIESI FARMACEUTICI SPA
Marketing Status:  Prescription
Patent and Exclusivity Information
JUXTAPID (LOMITAPIDE MESYLATE)
EQ 10MG BASE
Marketing Status: Prescription
Active Ingredient: LOMITAPIDE MESYLATE
Proprietary Name: JUXTAPID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203858
Product Number: 002
Approval Date: Dec 21, 2012
Applicant Holder Full Name: CHIESI FARMACEUTICI SPA
Marketing Status:  Prescription
Patent and Exclusivity Information
JUXTAPID (LOMITAPIDE MESYLATE)
EQ 20MG BASE
Marketing Status: Prescription
Active Ingredient: LOMITAPIDE MESYLATE
Proprietary Name: JUXTAPID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 20MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203858
Product Number: 003
Approval Date: Dec 21, 2012
Applicant Holder Full Name: CHIESI FARMACEUTICI SPA
Marketing Status:  Prescription
Patent and Exclusivity Information
JUXTAPID (LOMITAPIDE MESYLATE)
EQ 30MG BASE
Marketing Status: Prescription
Active Ingredient: LOMITAPIDE MESYLATE
Proprietary Name: JUXTAPID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203858
Product Number: 004
Approval Date: Apr 23, 2015
Applicant Holder Full Name: CHIESI FARMACEUTICI SPA
Marketing Status:  Prescription
Patent and Exclusivity Information
JUXTAPID (LOMITAPIDE MESYLATE)
EQ 40MG BASE
Marketing Status: Discontinued
Active Ingredient: LOMITAPIDE MESYLATE
Proprietary Name: JUXTAPID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203858
Product Number: 005
Approval Date: Apr 23, 2015
Applicant Holder Full Name: CHIESI FARMACEUTICI SPA
Marketing Status:  Discontinued
Patent and Exclusivity Information
JUXTAPID (LOMITAPIDE MESYLATE)
EQ 60MG BASE
Marketing Status: Discontinued
Active Ingredient: LOMITAPIDE MESYLATE
Proprietary Name: JUXTAPID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203858
Product Number: 006
Approval Date: Apr 23, 2015
Applicant Holder Full Name: CHIESI FARMACEUTICI SPA
Marketing Status:  Discontinued
Patent and Exclusivity Information
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