Orange Book product · Generic (ANDA)
TRANEXAMIC ACID
TRANEXAMIC ACID
At a glance
Nov 03, 2011
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 03, 2011
14 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
TRANEXAMIC ACID
Strength
100MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 091657
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TRANEXAMIC ACID
- 2019TRANEXAMIC ACIDBrand (NDA)
NDA 212020 · EXELA PHARMA
- 2009LYSTEDABrand (NDA)
NDA 022430 · AMRING PHARMS
- 1986CYKLOKAPRONBrand (NDA)
NDA 019281 · PFIZER
- 1986CYKLOKAPRONBrand (NDA)
NDA 019280 · PHARMACIA AND UPJOHN
- 2026TRANEXAMIC ACIDGeneric (ANDA)
ANDA 219702 · I 3 PHARMS
- 2025TRANEXAMIC ACIDGeneric (ANDA)
ANDA 219123 · BIONPHARMA
- 2025TRANEXAMIC ACIDGeneric (ANDA)
ANDA 218729 · APPCO
- 2025TRANEXAMIC ACIDGeneric (ANDA)
ANDA 218896 · HERITAGE
- 2024TRANEXAMIC ACIDGeneric (ANDA)
ANDA 218242 · FRESENIUS KABI USA
- 2024TRANEXAMIC ACIDGeneric (ANDA)
ANDA 218320 · RUBICON RESEARCH
- 2024TRANEXAMIC ACIDGeneric (ANDA)
ANDA 218599 · GLAND
- 2024TRANEXAMIC ACIDGeneric (ANDA)
ANDA 216877 · NEXUS
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.
