FDA Orange Book · active-ingredient family
Desloratadine; pseudoephedrine sulfate
Desloratadine; pseudoephedrine sulfate is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CLARINEX-D 12 HOUR · NDA 021313
2
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLARINEX-D 12 HOURRLD | ORGANON LLC | NDA 021313 | — | Feb 01, 2006 | |
| CLARINEX D 24 HOURRLD | ORGANON | NDA 021605 | — | Mar 03, 2005 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR | DR REDDYS LABS LTD | ANDA 078366 | — | Apr 26, 2011 |
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.
Desloratadine; pseudoephedrine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
