Orange Book product · Generic (ANDA)
AMBRISENTAN
AMBRISENTAN
At a glance
May 19, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 19, 2022
4 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
AMBRISENTAN
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 210701
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMBRISENTAN
- 2007LETAIRISBrand (NDA)
NDA 022081 · GILEAD
- 2022AMBRISENTANGeneric (ANDA)
ANDA 216531 · AUROBINDO PHARMA
- 2019AMBRISENTANGeneric (ANDA)
ANDA 210715 · CIPLA
- 2019AMBRISENTANGeneric (ANDA)
ANDA 209509 · PH HEALTH
- 2019AMBRISENTANGeneric (ANDA)
ANDA 208354 · SIGMAPHARM LABS LLC
- 2019AMBRISENTANGeneric (ANDA)
ANDA 208441 · MYLAN
- 2019AMBRISENTANGeneric (ANDA)
ANDA 210784 · SUN PHARM
- 2019AMBRISENTANGeneric (ANDA)
ANDA 208252 · WATSON LABS INC
- 2019AMBRISENTANGeneric (ANDA)
ANDA 210058 · ZYDUS PHARMS
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.
