Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022081

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LETAIRIS (AMBRISENTAN)
5MG
Marketing Status: Prescription

Active Ingredient: AMBRISENTAN
Proprietary Name: LETAIRIS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022081
Product Number: 001
Approval Date: Jun 15, 2007
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LETAIRIS (AMBRISENTAN)
10MG
Marketing Status: Prescription

Active Ingredient: AMBRISENTAN
Proprietary Name: LETAIRIS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022081
Product Number: 002
Approval Date: Jun 15, 2007
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information