Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021906

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KALETRA (LOPINAVIR; RITONAVIR)
100MG;25MG
Marketing Status: Prescription

Active Ingredient: LOPINAVIR; RITONAVIR
Proprietary Name: KALETRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG;25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021906
Product Number: 002
Approval Date: Nov 9, 2007
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

KALETRA (LOPINAVIR; RITONAVIR)
200MG;50MG
Marketing Status: Prescription

Active Ingredient: LOPINAVIR; RITONAVIR
Proprietary Name: KALETRA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG;50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021906
Product Number: 001
Approval Date: Oct 28, 2005
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information