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U.S. Department of Health and Human Services

FDA Application

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NDC Search Results on Active Ingredient: bosentan

Click on Active Ingredient to view the label.

Ingredient Name NDC Company Name Application Number or Regulatory Citation Product Type Marketing Category
BOSENTAN 66215-103-56  Actelion Pharmaceuticals US, Inc.  NDA209279  HUMAN PRESCRIPTION DRUG  NDA 
BOSENTAN 68382-446-14  Zydus Pharmaceuticals USA Inc.  ANDA207760  HUMAN PRESCRIPTION DRUG  ANDA 
BOSENTAN 47335-039-86  Sun Pharmaceutical Industries, Inc.  ANDA209324  HUMAN PRESCRIPTION DRUG  ANDA 
BOSENTAN 68382-447-77  Zydus Pharmaceuticals USA Inc.  ANDA207760  HUMAN PRESCRIPTION DRUG  ANDA 
BOSENTAN 66215-103-14  Actelion Pharmaceuticals US, Inc.  NDA209279  HUMAN PRESCRIPTION DRUG  NDA 
BOSENTAN 68382-446-28  Zydus Pharmaceuticals USA Inc.  ANDA207760  HUMAN PRESCRIPTION DRUG  ANDA 
BOSENTAN 66215-232-14  Actelion Pharmaceuticals US, Inc.  NDA209279  HUMAN PRESCRIPTION DRUG  NDA 
BOSENTAN 70771-1017-1  Zydus Lifesciences Limited  ANDA207760  HUMAN PRESCRIPTION DRUG  ANDA 
BOSENTAN 68382-447-01  Zydus Pharmaceuticals USA Inc.  ANDA207760  HUMAN PRESCRIPTION DRUG  ANDA 
BOSENTAN 0591-2512-60  Actavis Pharma, Inc.  ANDA207110  HUMAN PRESCRIPTION DRUG  ANDA 
BOSENTAN ANHYDROUS 65162-873-06  Amneal Pharmaceuticals LLC  ANDA209742  HUMAN PRESCRIPTION DRUG  ANDA 
BOSENTAN ANHYDROUS 65162-874-06  Amneal Pharmaceuticals LLC  ANDA209742  HUMAN PRESCRIPTION DRUG  ANDA 
1-30 31-42

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