| Product Information |
|
| Registration Number |
DRP-13946-01
|
| Generic Name |
Leuprorelin Acetate
|
| Brand Name |
Leustar
|
| Dosage Strength |
3.75 mg
|
| Dosage Form |
Powder for Injection (IM/SC)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Gonadotropin Releasing Hormone Analog
|
| 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 |
Pharmastar Int'l Trading Corp
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
13 December 2023
|
| Expiry Date |
23 May 2028
|