| Product Information |
|
| Registration Number |
DRP-13959
|
| Generic Name |
Tranexamic Acid
|
| Brand Name |
Tranez
|
| Dosage Strength |
100 mg/mL (500 mg/5 mL)
|
| Dosage Form |
Solution for Injection
(I.M./I.V.)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antifibrinolytic (Amino Acid)
|
| Packaging |
USP Type I Clear Glass Ampoule x 5 mL (Box of 10
ampoules x 5mL in plastic tray)
|
| Manufacturer |
Makcur Laboratories Limited
|
| Country of Origin |
India
|
| Trader |
Yeluri Formulations Pvt. Ltd.
|
| Importer |
Seapharma International, Inc
|
| Distributor |
Seapharma International, Inc
|
| Application Type |
Initial (Variation-turned-Initial)
|
| Issuance Date |
24 September 2024
|
| Expiry Date |
24 September 2029
|