FDA Orange Book · active-ingredient family
Chlorpheniramine maleate; pseudoephedrine hydrochloride
Chlorpheniramine maleate; pseudoephedrine hydrochloride is approved as 5 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE · NDA 019428
5
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE | CENT PHARMS | NDA 019428 | — | Aug 02, 1988 | |
| ISOCLOR | FISONS | NDA 018747 | — | Mar 06, 1986 | |
| CODIMAL-L.A. 12 | SCHWARZ PHARMA | NDA 018935 | — | Apr 15, 1985 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE | GRAHAM DM | NDA 018844 | — | Mar 20, 1985 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE | GRAHAM DM | NDA 018843 | — | Mar 18, 1985 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE | KV PHARM | ANDA 071455 | — | Mar 01, 1989 |
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.
Chlorpheniramine maleate; pseudoephedrine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
