| Product Information |
|
| Registration Number |
DRP-13558-04
|
| Generic Name |
Lapatinib (as ditosylate monohydrate)
|
| Brand Name |
Brestin
|
| Dosage Strength |
250 mg
|
| Dosage Form |
Film-Coated Tablet
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Antineoplastic Agent
|
| Packaging |
HDPE Bottle x 30 tablets / (Box of 1 bottle x 30 tablets)
|
| Manufacturer |
BDR Pharmaceuticals International Pvt. Ltd.–Oncology Unit
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Ambica International Corporation
|
| Distributor |
Kaufmann Pharma Inc.
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
04 September 2024
|
| Expiry Date |
09 March 2028
|