| Product Information |
|
| Registration Number |
DRP-10592
|
| Generic Name |
Paclitaxel
|
| Brand Name |
Saphxel
|
| Dosage Strength |
6mg/mL
|
| Dosage Form |
Solution For I.V. Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic
|
| Packaging |
USP Type I clear glass vial with grey bromobutyl
rubber stopper and aluminum flip-off seal(Box of l's) 5 mL (30 mg/5 mL net content); 20 mL (100 mg/ 16.7 mL net content); 50 mL (260 mg/ 43.4 mL net content); and 50 mL (300 mg/ 50.0 mL net content)
|
| Manufacturer |
Bruck Pharma Private Limited
|
| Country of Origin |
India
|
| Trader |
Sapphire Lifesciences Pvt. Ltd.
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Nelpa Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
03 November 2021
|
| Expiry Date |
26 October 2026
|