Product Details for ANDA 205391
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL)
12.5MG;20MG
Marketing Status: Prescription
12.5MG;40MG
Marketing Status: Prescription
25MG;40MG
Marketing Status: Prescription
12.5MG;20MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205391
Product Number: 001
Approval Date: Apr 24, 2017
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL)
Proprietary Name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205391
Product Number: 001
Approval Date: Apr 24, 2017
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
12.5MG;40MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205391
Product Number: 002
Approval Date: Apr 24, 2017
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL)
Proprietary Name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205391
Product Number: 002
Approval Date: Apr 24, 2017
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
25MG;40MG
Marketing Status: Prescription
Active Ingredient: HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Proprietary Name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205391
Product Number: 003
Approval Date: Apr 24, 2017
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG;40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205391
Product Number: 003
Approval Date: Apr 24, 2017
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information