Orange Book product
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER 100%
Orange Book NDA 019869 · OTSUKA ICU MEDICAL LLC · Prescription
Key facts
| Proprietary name | STERILE WATER FOR INJECTION IN PLASTIC CONTAINER |
|---|---|
| Active ingredients | STERILE WATER FOR INJECTION |
| Strength | 100% |
| Dosage form | LIQUID |
| Application | NDA019869 |
| Applicant holder | OTSUKA ICU MEDICAL LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Dec 26, 1989 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes 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.