| Product Information |
DR-XY47611_PI_01.pdf
|
| Registration Number |
DR-XY47611
|
| Generic Name |
Esketamine (as hydrochloride)
|
| Brand Name |
Spravato
|
| Dosage Strength |
28 mg
|
| Dosage Form |
Nasal Solution (Spray)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
Type I glass vial with chlorobutyl rubber stopper
assembled within an inhaler device with actuator sealed in a blister foil containing 2 actuation doses equivalent to 28 mg (Box of 1, 2 and 3 nasal spray devices equivalent to 28 mg, 56 mg and 84 mg, respectively)
|
| Manufacturer |
Renaissance Lakewood LLC
|
| Country of Origin |
United States of America
|
| Trader |
Janssen Pharmaceuticals, Inc.
|
| Importer |
Johnson & Johnson (Philippines), Inc.
|
| Distributor |
|
| Application Type |
Monitored Release
|
| Issuance Date |
16 December 2021
|
| Expiry Date |
16 December 2026
|