Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207110
Company: WATSON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription AB No No
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/26/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

BOSENTAN

TABLET;ORAL; 62.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 206002 ALVOGEN PINE BROOK
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 209742 AMNEAL PHARMS CO
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 206987 NATCO PHARMA LTD
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 205699 PAR PHARM INC
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 209324 SUN PHARM
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 207110 WATSON LABS INC
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 208695 WEST-WARD PHARMS INT
BOSENTAN BOSENTAN 62.5MG TABLET;ORAL Prescription No AB 207760 ZYDUS PHARMS
TRACLEER BOSENTAN 62.5MG TABLET;ORAL Prescription Yes AB 021290 ACTELION PHARMS LTD

TABLET;ORAL; 125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 206002 ALVOGEN PINE BROOK
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 209742 AMNEAL PHARMS CO
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 206987 NATCO PHARMA LTD
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 205699 PAR PHARM INC
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 209324 SUN PHARM
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 207110 WATSON LABS INC
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 208695 WEST-WARD PHARMS INT
BOSENTAN BOSENTAN 125MG TABLET;ORAL Prescription No AB 207760 ZYDUS PHARMS
TRACLEER BOSENTAN 125MG TABLET;ORAL Prescription Yes AB 021290 ACTELION PHARMS LTD

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