Orange Book product · Brand (NDA)
TRANEXAMIC ACID
TRANEXAMIC ACID
At a glance
Apr 15, 2019
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 15, 2019
7 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
TRANEXAMIC ACID
Strength
1GM/100ML (10MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 212020
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 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
- 2023TRANEXAMIC ACIDGeneric (ANDA)
ANDA 217155 · AMNEAL
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.
