Details for New Drug Application (NDA): 205035
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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 205035
Tradename: | TRANEXAMIC ACID |
Applicant: | Eugia Pharma |
Ingredient: | tranexamic acid |
Patents: | 0 |
Pharmacology for NDA: 205035
Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 205035
Suppliers and Packaging for NDA: 205035
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 205035 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1532 | 51662-1532-1 | 10 mL in 1 VIAL, SINGLE-DOSE (51662-1532-1) |
TRANEXAMIC ACID | tranexamic acid | INJECTABLE;INJECTION | 205035 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1532 | 51662-1532-3 | 10 POUCH in 1 CASE (51662-1532-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1532-2) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
Approval Date: | Jan 14, 2016 | TE: | AP | RLD: | No |
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