Orange Book product · Generic (ANDA)
MACITENTAN
MACITENTAN
At a glance
Dec 03, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 03, 2025
7 mo ago
Today
Pharmaceutical detail
Active ingredient
MACITENTAN
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 211161
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MACITENTAN
- 2013OPSUMITBrand (NDA)
NDA 204410 · ACTELION
- 2026MACITENTANGeneric (ANDA)
ANDA 211000 · AMNEAL
- 2026MACITENTANGeneric (ANDA)
ANDA 211187 · TEVA PHARMS USA INC
- 2025MACITENTANGeneric (ANDA)
ANDA 211026 · SEASONS BIOTECH
- 2025MACITENTANGeneric (ANDA)
ANDA 211120 · LAURUS
- 2025MACITENTANGeneric (ANDA)
ANDA 211123 · SUN PHARM
- 2025MACITENTANGeneric (ANDA)
ANDA 211136 · MSN
- 2025MACITENTANGeneric (ANDA)
ANDA 211128 · ALEMBIC
- 2024MACITENTANGeneric (ANDA)
ANDA 211107 · TORRENT
- 2024MACITENTANGeneric (ANDA)
ANDA 211195 · APOTEX
- 2023MACITENTANGeneric (ANDA)
ANDA 211198 · AUROBINDO PHARMA LTD
- 2021MACITENTANGeneric (ANDA)
ANDA 211224 · ZYDUS LIFESCIENCES
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.
