| Product Information |
|
| Registration Number |
DR-XY45971
|
| Generic Name |
Nepafenac
|
| Brand Name |
Nepalact
|
| Dosage Strength |
1 mg/mL (0.1% w/v)
|
| Dosage Form |
Sterile Ophthalmic Suspension (Eye Drops)
|
| Classification |
Prescription (Rx) Drug
|
| Pharmacologic Category |
Non-Steroidal Anti-inflammatory Drug (NSAID)
|
| Packaging |
5 mL (net content) translucent LDPE dropper bottle with translucent LDPE plug and opaque white HDPE pilfer-proof cap (Box of 1's)
|
| Manufacturer |
Sun Pharmaceutical Medicare Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Sun Pharma Philippines, Inc.
|
| Distributor |
Sun Pharma Philippines, Inc.
|
| Application Type |
Initial (from Monitored Release)
|
| Issuance Date |
07 August 2024
|
| Expiry Date |
07 August 2029
|