Details for New Drug Application (NDA): 218599
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NDA 218599 describes TRANEXAMIC ACID, which is a drug marketed by Am Regent, Amneal Pharms Co, Apotex, Avet Lifesciences, Caplin, Chartwell Rx, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Heritage, Micro Labs, Mylan Institutional, Provepharm Sas, Rising, Xgen Pharms, Zydus Pharms, Amneal, Exela Pharma, Gland Pharma Ltd, Nexus, Actavis Labs Fl Inc, Ani Pharms, Aurobindo Pharma Usa, and Rubicon, and is included in twenty-eight NDAs. It is available from thirty-five suppliers. Additional details are available on the TRANEXAMIC ACID profile page.
The generic ingredient in TRANEXAMIC ACID is tranexamic acid. There are eight drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
The generic ingredient in TRANEXAMIC ACID is tranexamic acid. There are eight drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
Summary for 218599
| Tradename: | TRANEXAMIC ACID |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | tranexamic acid |
| Patents: | 0 |
Pharmacology for NDA: 218599
| Physiological Effect | Decreased Fibrinolysis |
Medical Subject Heading (MeSH) Categories for 218599
Suppliers and Packaging for NDA: 218599
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRANEXAMIC ACID | tranexamic acid | SOLUTION;INTRAVENOUS | 218599 | ANDA | Sagent Pharmaceuticals | 25021-418 | 25021-418-82 | 10 BAG in 1 CARTON (25021-418-82) / 100 mL in 1 BAG |
| TRANEXAMIC ACID | tranexamic acid | SOLUTION;INTRAVENOUS | 218599 | ANDA | Gland Pharma Limited | 68083-613 | 68083-613-10 | 10 POUCH in 1 CARTON (68083-613-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1GM/100ML (10MG/ML) | ||||
| Approval Date: | Apr 16, 2024 | TE: | AP | RLD: | No | ||||
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