Details for New Drug Application (NDA): 218320
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The generic ingredient in TRANEXAMIC ACID is tranexamic acid. There are eight drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
Summary for 218320
Tradename: | TRANEXAMIC ACID |
Applicant: | Rubicon |
Ingredient: | tranexamic acid |
Patents: | 0 |
Pharmacology for NDA: 218320
Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 218320
Suppliers and Packaging for NDA: 218320
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRANEXAMIC ACID | tranexamic acid | TABLET;ORAL | 218320 | ANDA | ADVAGEN PHARMA LIMITED | 72888-178 | 72888-178-01 | 100 TABLET in 1 BOTTLE (72888-178-01) |
TRANEXAMIC ACID | tranexamic acid | TABLET;ORAL | 218320 | ANDA | ADVAGEN PHARMA LIMITED | 72888-178 | 72888-178-05 | 500 TABLET in 1 BOTTLE (72888-178-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 650MG | ||||
Approval Date: | Jun 11, 2024 | TE: | AB | RLD: | No |
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