| Product Information |
|
| Registration Number |
DRP-14785
|
| Generic Name |
Carboplatin
|
| Brand Name |
None
|
| Dosage Strength |
150 mg/15 mL (10 mg/mL) and 450 mg/mL (10 mg/mL)
|
| Dosage Form |
Solution for Intravenous Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
15 mL net content USP Type I Amber glass vial with grey bromo butyl rubber stopper and aluminum seal with brown flip-off cap (Box of 1's); and
45 mL net content USP Type I Amber glass vial with grey bromo butyl rubber stopper and aluminum seal with brown flip-off cap (Box of 1's)
|
| Manufacturer |
Hetero Labs Limited (Unit VI)
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Camber Pharmaceuticals, Inc.
|
| Distributor |
Camber Pharmaceuticals, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
04 January 2024
|
| Expiry Date |
04 January 2029
|