Orange Book product
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 60MG;120MG
Orange Book ANDA 076667 · DR REDDYS LABORATORIES LTD · Over the counter
Key facts
| Proprietary name | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|---|
| Active ingredients | FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE |
| Strength | 60MG;120MG |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA076667 |
| Applicant holder | DR REDDYS LABORATORIES LTD |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Nov 18, 2014 |
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.