Details for New Drug Application (NDA): 219702
✉ Email this page to a colleague
NDA 219702 describes TRANEXAMIC ACID, which is a drug marketed by Am Regent, Amneal Pharms Co, Apotex, Avet Lifesciences, Caplin, Chartwell Rx, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Heritage, Micro Labs, Milla Pharms, Mylan Institutional, Rising, Xgen Pharms, Zydus Pharms, Amneal, Exela Pharma, Nexus, Actavis Labs Fl Inc, Ani Pharms, Appco, Aurobindo Pharma Usa, Bionpharma, I 3 Pharms, and Rubicon Research, and is included in thirty-two NDAs. It is available from thirty-five suppliers. Additional details are available on the TRANEXAMIC ACID profile page.
The generic ingredient in TRANEXAMIC ACID is tranexamic acid. There are eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
The generic ingredient in TRANEXAMIC ACID is tranexamic acid. There are eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
Summary for 219702
| Tradename: | TRANEXAMIC ACID |
| Applicant: | I 3 Pharms |
| Ingredient: | tranexamic acid |
| Patents: | 0 |
Pharmacology for NDA: 219702
| Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 219702
Suppliers and Packaging for NDA: 219702
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRANEXAMIC ACID | tranexamic acid | TABLET;ORAL | 219702 | ANDA | i3 Pharmaceuticals, LLC | 72319-028 | 72319-028-01 | 30 TABLET in 1 BOTTLE, PLASTIC (72319-028-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 650MG | ||||
| Approval Date: | Jan 26, 2026 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
