Orange Book product · Brand (NDA)
CYKLOKAPRON
TRANEXAMIC ACID
At a glance
Dec 30, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 30, 1986
40 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
TRANEXAMIC ACID
Strength
500MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 019280
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2019TRANEXAMIC ACIDBrand (NDA)
NDA 212020 · EXELA PHARMA
- 2009LYSTEDABrand (NDA)
NDA 022430 · AMRING PHARMS
- 1986CYKLOKAPRONBrand (NDA)
NDA 019281 · PFIZER
- 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.

