Details for New Drug Application (NDA): 203521
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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 203521
Tradename: | TRANEXAMIC ACID |
Applicant: | Avet Lifesciences |
Ingredient: | tranexamic acid |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203521
Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 203521
Suppliers and Packaging for NDA: 203521
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 203521 | ANDA | Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | 23155-166 | 23155-166-41 | 10 VIAL, GLASS in 1 CARTON (23155-166-41) / 10 mL in 1 VIAL, GLASS (23155-166-31) |
TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 203521 | ANDA | Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | 23155-524 | 23155-524-41 | 10 VIAL, GLASS in 1 CARTON (23155-524-41) / 10 mL in 1 VIAL, GLASS (23155-524-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
Approval Date: | Aug 12, 2014 | TE: | AP | RLD: | No |
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