Orange Book product
LABETALOL HYDROCHLORIDE 5MG/ML
Orange Book ANDA 214533 · CAPLIN STERILES LTD · Prescription
Key facts
| Proprietary name | LABETALOL HYDROCHLORIDE |
|---|---|
| Active ingredients | LABETALOL HYDROCHLORIDE |
| Strength | 5MG/ML |
| Dosage form | INJECTABLE |
| Route | INJECTION |
| Application | ANDA214533 |
| Applicant holder | CAPLIN STERILES LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 7, 2021 |
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.