| Product Information |
|
| Registration Number |
DRP-13433
|
| Generic Name |
Ketotifen (As Hydrogen Fumarate)
|
| Brand Name |
Saphtifen
|
| Dosage Strength |
1mg/5mL
|
| Dosage Form |
Syrup
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
60 mL and 120 mL round amber PET bottle (Box of 1's)
|
| Manufacturer |
Azine Healthcare Pvt. Ltd.
|
| Country of Origin |
India
|
| Trader |
Sapphire Lifesciences Pvt. Ltd.
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Nelpa Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
17 February 2023
|
| Expiry Date |
17 February 2028
|