Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216531

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AMBRISENTAN (AMBRISENTAN)
5MG
Marketing Status: Prescription

Active Ingredient: AMBRISENTAN
Proprietary Name: AMBRISENTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216531
Product Number: 001
Approval Date: Jul 21, 2022
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

AMBRISENTAN (AMBRISENTAN)
10MG
Marketing Status: Prescription

Active Ingredient: AMBRISENTAN
Proprietary Name: AMBRISENTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216531
Product Number: 002
Approval Date: Jul 21, 2022
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information