Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202331

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EDARBYCLOR (AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE)
EQ 40MG MEDOXOMIL;12.5MG Marketing Status: Prescription

Active Ingredient: AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
Proprietary Name: EDARBYCLOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG MEDOXOMIL;12.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202331
Product Number: 001
Approval Date: Dec 20, 2011
Applicant Holder Full Name: ARBOR PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

EDARBYCLOR (AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE)
EQ 40MG MEDOXOMIL;25MG Marketing Status: Prescription

Active Ingredient: AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
Proprietary Name: EDARBYCLOR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG MEDOXOMIL;25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202331
Product Number: 002
Approval Date: Dec 20, 2011
Applicant Holder Full Name: ARBOR PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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