| Product Information |
|
| Registration Number |
DR-XY45714
|
| Generic Name |
Ceftolozane (as sulfate) + Tazobactam (as sodium)
|
| Brand Name |
Zerbaxa
|
| Dosage Strength |
1 g/500 mg
|
| Dosage Form |
Powder for Injection (I.V. Infusion)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
-
|
| Packaging |
20 mL-capacity USP Type I clear and colorless glass vial ealed with bromobutyl rubber stopper and aluminum seal with purple plastic flip-off cap (Box of 10's)
|
| Manufacturer |
Steri-Pharma, LLC
|
| Country of Origin |
United States of America
|
| Trader |
N/A
|
| Importer |
Merck Sharp & Dohme (I.A.) LLC
|
| Distributor |
N/A
|
| Application Type |
Initial (from Monitored Release)
|
| Issuance Date |
16 February 2023
|
| Expiry Date |
19 December 2026
|