| Product Information |
|
| Registration Number |
DRP-12327
|
| Generic Name |
Paclitaxel
|
| Brand Name |
Taxitas-100
|
| Dosage Strength |
6 mg/mL (100 mg/16.7 mL)
|
| Dosage Form |
Concentrate Solution for
I.V. Infusion
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic (Taxane)
|
| Packaging |
USP Type I amber color molded glass vial with grey
bromobutyl rubber plug and sealed with flip off seal orange color x 16.7 mL (net content). Box of l’s.
|
| Manufacturer |
ADMAC Lifesciences
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Suhitas Pharmaceuticals Inc.
|
| Distributor |
Suhitas Pharmaceuticals Inc.
|
| Application Type |
Initial (Re application)
|
| Issuance Date |
15 July 2022
|
| Expiry Date |
15 July 2027
|