| Product Information |
|
| Registration Number |
DRP-13123
|
| Generic Name |
Prednisolone (As Acetate)
|
| Brand Name |
Saphnisolone-S10
|
| Dosage Strength |
10mg/mL (1% w/v)
|
| Dosage Form |
Ophthalmic Suspension (eye drops)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
White LDPE Plastic
Plastic Dropper Bottle x 5 mL (Box of 1's)
|
| Manufacturer |
Kilitch Drugs (India) Ltd.
|
| Country of Origin |
India
|
| Trader |
Sapphire Lifesciences Pvt. Ltd.
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Nelpa Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
02 December 2022
|
| Expiry Date |
02 December 2027
|