Orange Book product
STERILE WATER FOR INJECTION 100%
Orange Book ANDA 212735 · HIKMA PHARMACEUTICALS INTERNATIONAL LTD · Prescription
Key facts
| Proprietary name | STERILE WATER FOR INJECTION |
|---|---|
| Active ingredients | STERILE WATER FOR INJECTION |
| Strength | 100% |
| Dosage form | LIQUID |
| Application | ANDA212735 |
| Applicant holder | HIKMA PHARMACEUTICALS INTERNATIONAL LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jan 31, 2023 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.