| Product Information |
|
| Registration Number |
DRP-14629
|
| Generic Name |
Atosiban (as acetate)
|
| Brand Name |
Tracsiban
|
| Dosage Strength |
7.5 mg (equivalent to 7.953 mg Atosiban Acetate)/mL
|
| Dosage Form |
Solution for Injection (IM/IV/SC)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Other Gynecologicals
|
| Packaging |
Type I USP Clear Vial with Blue Aluminum Cap and
Butyl Rubber Stopper x 5 mL (Box of 1's)
|
| Manufacturer |
Hanlim Pharm. Co., Ltd.
|
| Country of Origin |
Korea
|
| Trader |
|
| Importer |
Ambica International Corporation
|
| Distributor |
Ambica International Corporation
|
| Application Type |
Initial
|
| Issuance Date |
11 September 2024
|
| Expiry Date |
11 September 2029
|