FDA Orange Book · active-ingredient family
Isoproterenol hydrochloride; phenylephrine bitartrate
Isoproterenol hydrochloride; phenylephrine bitartrate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:DUO-MEDIHALER · NDA 013296
1
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DUO-MEDIHALER | 3M | NDA 013296 | — | 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.
Isoproterenol hydrochloride; phenylephrine bitartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
