Viewing data from:

TRANEXAMIC ACID

NDA

TRANEXAMIC ACID | N212020 | EXELA PHARMA SCIENCES LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain9 active DMFs3 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

HUNAN DONGTING PHARMACEUTICAL CO LTDTRANEXAMIC ACID

DMF 141811999

ALP PHARM BEIJING CO LTDTRANEXAMIC ACID

DMF 222772008

ASAHI KASEI FINECHEM CO LTDTRANEXAMIC ACID USP

DMF 253312011

KYOWA PHARMA CHEMICAL CO LTDTRANEXAMIC ACID DRUG SUBSTANCE

DMF 261282012

SHILPA PHARMA LIFESCIENCES LTDTRANEXAMIC ACID USP

DMF 330862018

AMI LIFESCIENCES PRIVATE LTDTRANEXAMIC ACID USP

DMF 363362021

MALLADI DRUGS AND PHARMACEUTICALS LTDTRANEXAMIC ACID

DMF 371302022

KP MANISH GLOBAL INGREDIENTS PVT LTDTRANEXAMIC ACID USP

DMF 398252024

ZHEJIANG BAMBOO PHARMACEUTICALS CO LTDTRANEXAMIC ACID

DMF 414072025

DAIICHI SANKYO CO LTDInactiveTRANEXAMIC ACID

DMF 38641980

PHARMACIA AND UPJOHNInactiveTRANEXAMIC ACID

DMF 48561983

CMIC CMO CO LTDInactiveTRANEXAMIC ACID

DMF 94181991

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 20, 2020	SUPPL -3	View Letter (PDF)
Apr 24, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1GM/100ML (10MG/ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Apr 15, 2019

No patent or exclusivity listings for this strength.