| Product Information |
|
| Registration Number |
DRP-15512
|
| Generic Name |
Carboplatin
|
| Brand Name |
None
|
| Dosage Strength |
10 mg/mL (150 mg/ 15 mL and 450 mg/ 45 mL)
|
| Dosage Form |
Concentrate Solution for IV Infusion
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Platinum Compound
|
| Packaging |
15 mL (fill volume) in 20 mL-capacity USP Type I
(fill Amber Vial (Box of 1's); 45 mL (fill volume) in 50 mL- capacity USP Type I Amber Vial (Box of 1's)
|
| Manufacturer |
Therdose Pharma Pvt. Ltd.
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Medethix, Inc.
|
| Distributor |
Medethix, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
30 July 2024
|
| Expiry Date |
30 July 2029
|