Details for New Drug Application (NDA): 218599
✉ Email this page to a colleague
The generic ingredient in TRANEXAMIC ACID is tranexamic acid. There are eight drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
Summary for 218599
Tradename: | TRANEXAMIC ACID |
Applicant: | Gland Pharma Ltd |
Ingredient: | tranexamic acid |
Patents: | 0 |
Pharmacology for NDA: 218599
Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 218599
Suppliers and Packaging for NDA: 218599
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRANEXAMIC ACID | tranexamic acid | SOLUTION;INTRAVENOUS | 218599 | ANDA | Gland Pharma Limited | 68083-613 | 68083-613-10 | 10 POUCH in 1 CARTON (68083-613-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/100ML (10MG/ML) | ||||
Approval Date: | Apr 16, 2024 | TE: | AP | RLD: | No |
Complete Access Available with Subscription