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Abbreviated New Drug Application (ANDA): 205699
Company: PAR PHARM 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 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205699Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/29/2022 SUPPL-3 REMS - MODIFIED - D-N-A

Label is not available on this site.

11/04/2019 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

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 208695 HIKMA
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 207760 ZYDUS PHARMS
TRACLEER BOSENTAN 62.5MG TABLET;ORAL Prescription Yes AB 021290 ACTELION

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 208695 HIKMA
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 207760 ZYDUS PHARMS
TRACLEER BOSENTAN 125MG TABLET;ORAL Prescription Yes AB 021290 ACTELION
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