Details for New Drug Application (NDA): 091596
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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 091596
Tradename: | TRANEXAMIC ACID |
Applicant: | Fresenius Kabi Usa |
Ingredient: | tranexamic acid |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091596
Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 091596
Suppliers and Packaging for NDA: 091596
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 091596 | ANDA | Fresenius Kabi USA, LLC | 63323-563 | 63323-563-10 | 10 VIAL in 1 TRAY (63323-563-10) / 10 mL in 1 VIAL (63323-563-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
Approval Date: | Mar 2, 2012 | TE: | AP | RLD: | No |
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