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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205173

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BOSENTAN (BOSENTAN)
62.5MG
Marketing Status: Discontinued
Active Ingredient: BOSENTAN
Proprietary Name: BOSENTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 62.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A205173
Product Number: 001
Approval Date: Jan 15, 2020
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
BOSENTAN (BOSENTAN)
125MG
Marketing Status: Discontinued
Active Ingredient: BOSENTAN
Proprietary Name: BOSENTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 125MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A205173
Product Number: 002
Approval Date: Jan 15, 2020
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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