Details for New Drug Application (NDA): 205133
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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 205133
Tradename: | TRANEXAMIC ACID |
Applicant: | Aurobindo Pharma Usa |
Ingredient: | tranexamic acid |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205133
Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 205133
Suppliers and Packaging for NDA: 205133
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRANEXAMIC ACID | tranexamic acid | TABLET;ORAL | 205133 | ANDA | Aurobindo Pharma Limited | 59651-839 | 59651-839-30 | 30 TABLET in 1 BOTTLE (59651-839-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 650MG | ||||
Approval Date: | Sep 21, 2015 | TE: | AB | RLD: | No |
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