Orange Book product · Brand (NDA)
LYSTEDA
TRANEXAMIC ACID
At a glance
Nov 13, 2009
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 13, 2009
16 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
TRANEXAMIC ACID
Strength
650MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 022430
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.
- 2019TRANEXAMIC ACIDBrand (NDA)
NDA 212020 · EXELA PHARMA
- 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.
