| Product Information |
|
| Registration Number |
DRP-13946
|
| Generic Name |
Leuprolide Acetate
|
| Brand Name |
Blirelin
|
| Dosage Strength |
3.75mg
|
| Dosage Form |
Powder For Injection (IM/SC)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
USP Type I clear glass vial x 5 mL with rubber stopper, aluminum seal and blue flip-off cap (drug product) + USP Type I glass ampoule x 3 mL (2 mL net content solvent) (Box of 1 vial and 1 ampoule)
|
| Manufacturer |
Dongkook Pharmaceutical Co., Ltd.
|
| Country of Origin |
Korea
|
| Trader |
N/A
|
| Importer |
Bliss Pharma Distribution and Consultancy Corp.
|
| Distributor |
Bliss Pharma Distribution and Consultancy Corp.
|
| Application Type |
Initial
|
| Issuance Date |
23 May 2023
|
| Expiry Date |
23 May 2028
|