FDA Orange Book · active-ingredient family
Loratadine; pseudoephedrine sulfate
Loratadine; pseudoephedrine sulfate is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CLARITIN-D · NDA 019670
2
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLARITIN-DRLD | BAYER HEALTHCARE LLC | NDA 019670 | — | Nov 27, 2002 | |
| CLARITIN-D 24 HOURRLD | BAYER HEALTHCARE LLC | NDA 020470 | — | Nov 27, 2002 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LORATADINE AND PSEUDOEPHEDRINE SULFATE | BIONPHARMA | ANDA 218017 | — | May 14, 2024 | |
| LORATADINE AND PSEUDOEPHEDRINE SULFATE | SUN PHARM INDS LTD | ANDA 076557 | — | Sep 22, 2004 | |
| LORATADINE AND PSEUDOEPHEDRINE SULFATE | PERRIGO PHARMA INTL | ANDA 075989 | — | Mar 04, 2004 | |
| LORATADINE AND PSEUDOEPHEDRINE SULFATE | HERITAGE PHARMA | ANDA 076208 | — | Jan 28, 2004 | |
| LORATADINE AND PSEUDOEPHEDRINE SULFATE | P AND L | ANDA 075706 | — | Feb 21, 2003 | |
| LORATADINE AND PSEUDOEPHEDRINE SULFATE | PERRIGO PHARMA INTL | ANDA 076050 | — | Jan 30, 2003 |
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.
Loratadine; pseudoephedrine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
