Details for New Drug Application (NDA): 205228
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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 205228
Tradename: | TRANEXAMIC ACID |
Applicant: | Zydus Pharms |
Ingredient: | tranexamic acid |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205228
Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 205228
Suppliers and Packaging for NDA: 205228
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 205228 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-891 | 68382-891-07 | 10 VIAL in 1 CARTON (68382-891-07) / 10 mL in 1 VIAL |
TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 205228 | ANDA | Zydus Lifesciences Limited | 70771-1085 | 70771-1085-6 | 10 VIAL in 1 CARTON (70771-1085-6) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
Approval Date: | Jul 17, 2017 | TE: | RLD: | No |
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