| Product Information |
|
| Registration Number |
DRP-15278
|
| Generic Name |
Docetaxel
|
| Brand Name |
Olletaxel-40
|
| Dosage Strength |
40 mg/mL (120 mg/3 mL)
|
| Dosage Form |
Concentrate Solution for
Injection (IV Infusion)
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Antineoplastic Agent (Taxane)
|
| Packaging |
Type 1 Clear Glass Vial Sealed with Gray Bromobutyl Rubber Stopper and Non-Tear Off Aluminum Seal with PP Flip-Off Cap x 3 mL + Sterile Water for Injection. in Type I Clear Glass Vial x 9 mL (Diluent) (Box of 1's)
|
| Manufacturer |
Bruck Pharma Private Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Ollen Pharma Trading, Inc.
|
| Distributor |
Ollen Pharma Trading, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
04 June 2024
|
| Expiry Date |
04 June 2029
|