Orange Book product
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE 220MG;120MG
Orange Book ANDA 077381 · DR REDDYS LABORATORIES INC · Over the counter
Key facts
| Proprietary name | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|---|
| Active ingredients | NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE |
| Strength | 220MG;120MG |
| Dosage form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Application | ANDA077381 |
| Applicant holder | DR REDDYS LABORATORIES INC |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Sep 27, 2006 |
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.