FDA Orange Book · active-ingredient family
Naproxen sodium; pseudoephedrine hydrochloride
Naproxen sodium; pseudoephedrine hydrochloride is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ALEVE-D SINUS & COLD · NDA 021076
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALEVE-D SINUS & COLDRLD | BAYER | NDA 021076 | — | Nov 29, 1999 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | AUROBINDO PHARMA | ANDA 211360 | — | Jun 01, 2022 | |
| NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | DR REDDYS LABS INC | ANDA 077381 | — | Sep 27, 2006 | |
| NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | PERRIGO | ANDA 076518 | — | Mar 17, 2004 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Naproxen sodium; pseudoephedrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
