| Product Information |
|
| Registration Number |
DRP-15388
|
| Generic Name |
Irbesartan
|
| Brand Name |
Irbesaph-300
|
| Dosage Strength |
300 mg
|
| Dosage Form |
Film-Coated Tablet
|
| Classification |
Prescription Drug (Rx)
|
| Pharmacologic Category |
Angiotensin II Receptor Blocker (ARB)
|
| Packaging |
Alu/Alu Blister Pack x 10's (Box of 30's); Alu/Alu
Blister Pack x 7's (Box of 35's)
|
| Manufacturer |
Sapphire Lifesciences Pvt. Ltd.
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Ollen Pharma Trading Inc.
|
| Distributor |
Ollen Pharma Trading, Inc.
|
| Application Type |
Initial (Re-application)
|
| Issuance Date |
02 July 2024
|
| Expiry Date |
02 July 2029
|