Orange Book product
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG
Orange Book ANDA 079112 · TIME CAP LABORATORIES INC · Over the counter
Key facts
| Proprietary name | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES |
|---|---|
| Active ingredients | FEXOFENADINE HYDROCHLORIDE |
| Strength | 30MG |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA079112 |
| Applicant holder | TIME CAP LABORATORIES INC |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Feb 8, 2012 |
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.