Orange Book product · Brand (NDA)
TRACLEER
BOSENTAN
At a glance
Nov 20, 2001
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 20, 2001
24 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BOSENTAN
Strength
62.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021290
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2017TRACLEERBrand (NDA)
NDA 209279 · ACTELION
- 2026BOSENTANGeneric (ANDA)
ANDA 213981 · ZYDUS PHARMS
- 2025BOSENTANGeneric (ANDA)
ANDA 213154 · NATCO PHARMA LTD
- 2020BOSENTANGeneric (ANDA)
ANDA 211461 · ALEMBIC
- 2020BOSENTANGeneric (ANDA)
ANDA 205173 · MYLAN
- 2020BOSENTANGeneric (ANDA)
ANDA 210342 · CHARTWELL MOLECULAR
- 2019BOSENTANGeneric (ANDA)
ANDA 206002 · ALVOGEN PINE BROOK
- 2019BOSENTANGeneric (ANDA)
ANDA 209742 · AMNEAL PHARMS CO
- 2019BOSENTANGeneric (ANDA)
ANDA 208695 · HIKMA
- 2019BOSENTANGeneric (ANDA)
ANDA 206987 · NATCO PHARMA LTD
- 2019BOSENTANGeneric (ANDA)
ANDA 205699 · PH HEALTH
- 2019BOSENTANGeneric (ANDA)
ANDA 209324 · SUN PHARM
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
