| Product Information |
|
| Registration Number |
DRP-6569-01
|
| Generic Name |
Isotretinoin
|
| Brand Name |
Karakleen
|
| Dosage Strength |
10 mg
|
| Dosage Form |
Softgel Capsule
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Anti-acne
|
| Packaging |
Clear PVC/Alu Blister Pack x 10's Box of 30’s
|
| Manufacturer |
Phil Inter Pharma Co., Ltd. (Plant 1)
|
| Country of Origin |
Vietnam
|
| Trader |
N/A
|
| Importer |
Ambicare Pharmaceuticals Inc.
|
| Distributor |
Kaufmann Pharma Inc.
|
| Application Type |
Renewal
|
| Issuance Date |
13 January 2023
|
| Expiry Date |
15 November 2028
|