Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203012

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OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL)
5MG
Marketing Status: Prescription

Active Ingredient: OLMESARTAN MEDOXOMIL
Proprietary Name: OLMESARTAN MEDOXOMIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203012
Product Number: 001
Approval Date: Apr 24, 2017
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL)
20MG
Marketing Status: Prescription

Active Ingredient: OLMESARTAN MEDOXOMIL
Proprietary Name: OLMESARTAN MEDOXOMIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203012
Product Number: 002
Approval Date: Apr 24, 2017
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL)
40MG
Marketing Status: Prescription

Active Ingredient: OLMESARTAN MEDOXOMIL
Proprietary Name: OLMESARTAN MEDOXOMIL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203012
Product Number: 003
Approval Date: Apr 24, 2017
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information