| Product Information |
|
| Registration Number |
DR-XY48015
|
| Generic Name |
Levetiracetam
|
| Brand Name |
Setam
|
| Dosage Strength |
100 mg/mL (500 mg/5 mL)
|
| Dosage Form |
Solution for Injection (I.V. Infusion)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
5 mL (net content) USP Type I clear and colorless glass
vial with gray elastic rubber stopper and aluminum seal with plastic flip-off cap (box of 5 vials and 10 vials)
|
| Manufacturer |
Baxter Pharmaceuticals India Private Limited
|
| Country of Origin |
India
|
| Trader |
N/A
|
| Importer |
Baxter Healthcare Philippines, Inc.
|
| Distributor |
Baxter Healthcare Philippines, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
16 May 2022
|
| Expiry Date |
16 May 2027
|