Details for New Drug Application (NDA): 212020
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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 212020
Tradename: | TRANEXAMIC ACID |
Applicant: | Exela Pharma |
Ingredient: | tranexamic acid |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212020
Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 212020
Suppliers and Packaging for NDA: 212020
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRANEXAMIC ACID | tranexamic acid | SOLUTION;INTRAVENOUS | 212020 | NDA | Exela Pharma Sciences, LLC | 51754-0108 | 51754-0108-1 | 100 mL in 1 BAG (51754-0108-1) |
TRANEXAMIC ACID | tranexamic acid | SOLUTION;INTRAVENOUS | 212020 | NDA | Exela Pharma Sciences, LLC | 51754-0108 | 51754-0108-3 | 1000 mL in 1 CASE (51754-0108-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/100ML (10MG/ML) | ||||
Approval Date: | Apr 15, 2019 | TE: | AP | RLD: | Yes |
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