FDA Orange Book · active-ingredient family
Chlorpheniramine maleate; phenylpropanolamine hydrochloride
Chlorpheniramine maleate; phenylpropanolamine hydrochloride is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:COLD CAPSULE IV · NDA 018793
3
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COLD CAPSULE IV | GRAHAM DM | NDA 018793 | — | Apr 25, 1985 | |
| COLD CAPSULE V | GRAHAM DM | NDA 018794 | — | Apr 23, 1985 | |
| TRIAMINIC-12 | NOVARTIS | NDA 018115 | — | Approved Prior to Jan 1, 1982 |
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; phenylpropanolamine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
