| Product Information |
|
| Registration Number |
BR-991
|
| Generic Name |
Urofollitropin
|
| Brand Name |
Endogen HP
|
| Dosage Strength |
75 IU
|
| Dosage Form |
Lyophilized Powder for Solution for Injection
(IM/SC)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
2 mL USP Type I clear glass vial with grey bromobutyl
rubber stopper and aluminum flip-off seal (urofollitropin as drug product) + 2 mL (Net content: 1 mL) USP Type I clear glass ampoule (0.9% sodium chloride as diluent) [Box of l’s]
|
| Pharmacologic Category |
Gonadotropins
|
| Manufacturer |
Sanzyme (P) Ltd.
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
MedEthix Inc.
|
| Distributor |
MedEthix Inc.
|
| Application Type |
Initial (from Monitored Release)
|
| Issuance Date |
27 July 2022
|
| Expiry Date |
11 April 2027
|