| Product Information |
|
| Registration Number |
DRP-14895
|
| Generic Name |
Abiraterone Acetate
|
| Brand Name |
Prostarex
|
| Dosage Strength |
250 mg
|
| Dosage Form |
Tablet
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Endocrine Therapy (Hormone Antagonist and Related
Agent)
|
| Packaging |
HDPE white plastic bottle with child-resistant PP cap (Box of 120's)
|
| Manufacturer |
Globela Pharma Private Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
AMB HK Enterprises Inc.
|
| Distributor |
AMB HK Enterprises Inc.
|
| Application Type |
Initial
|
| Issuance Date |
13 February 2024
|
| Expiry Date |
13 February 2029
|