Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 200796

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EDARBI (AZILSARTAN KAMEDOXOMIL)
EQ 40MG MEDOXOMIL Marketing Status: Prescription

Active Ingredient: AZILSARTAN KAMEDOXOMIL
Proprietary Name: EDARBI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG MEDOXOMIL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N200796
Product Number: 001
Approval Date: Feb 25, 2011
Applicant Holder Full Name: ARBOR PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

EDARBI (AZILSARTAN KAMEDOXOMIL)
EQ 80MG MEDOXOMIL Marketing Status: Prescription

Active Ingredient: AZILSARTAN KAMEDOXOMIL
Proprietary Name: EDARBI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 80MG MEDOXOMIL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N200796
Product Number: 002
Approval Date: Feb 25, 2011
Applicant Holder Full Name: ARBOR PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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