DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 203521
NDA 203521 describes TRANEXAMIC ACID, which is a drug marketed by Acic Fine Chems, Akorn, Amneal Pharms Co, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Luitpold, Mylan Institutional, Virtus Pharms, Viva Hlthcare, X-gen Pharms Inc, Zydus Pharms Usa Inc, Actavis Labs Fl Inc, Amerigen Pharms Ltd, Apotex Inc, and Mylan, and is included in nineteen NDAs. It is available from nineteen suppliers. Additional details are available on the TRANEXAMIC ACID profile page.
The generic ingredient in TRANEXAMIC ACID is tranexamic acid. There are seven drug master file entries for this compound. Twenty-three 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 seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the tranexamic acid profile page.
Summary for 203521
| Tradename: | TRANEXAMIC ACID |
| Applicant: | Emcure Pharms Ltd |
| Ingredient: | tranexamic acid |
| Patents: | 0 |
| Therapeutic Class: | Blood Products/Modifiers/ Volume Expanders |
| 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 Inc. | 23155-166 | N | 23155-166-41 |
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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