FDA Orange Book · active-ingredient family
Isoproterenol hydrochloride
Isoproterenol hydrochloride is approved as 8 brand and 29 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ISUPREL · NDA 010515
8
Brand (NDA)
29
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, metered, disc, injectable, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ISUPRELRLD | BAUSCH | NDA 010515 | — | Approved Prior to Jan 1, 1982 | |
| ISOPROTERENOL HYDROCHLORIDE | 3M | NDA 010375 | — | Approved Prior to Jan 1, 1982 | |
| ISUPREL | SANOFI AVENTIS US | NDA 011178 | — | Approved Prior to Jan 1, 1982 | |
| NORISODRINE AEROTROL | ABBOTT | NDA 016814 | — | Approved Prior to Jan 1, 1982 | |
| AEROLONE | LILLY | NDA 007245 | — | Approved Prior to Jan 1, 1982 | |
| ISUPREL×2 | SANOFI AVENTIS US | NDA 006327 | — | Approved Prior to Jan 1, 1982 | |
| VAPO-ISO | FISONS | NDA 016813 | — | Approved Prior to Jan 1, 1982 | |
| ISUPREL×2 | SANOFI AVENTIS US | NDA 006328 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (29)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ISOPROTERENOL HYDROCHLORIDE | ASPIRO | ANDA 220299 | AP | May 18, 2026 | |
| ISOPROTERENOL HYDROCHLORIDE | DEVA HOLDING AS | ANDA 213305 | AP | Dec 10, 2025 | |
| ISOPROTERENOL HYDROCHLORIDE | GLAND | ANDA 217648 | AP | Oct 03, 2024 | |
| ISOPROTERENOL HYDROCHLORIDE | SOMERSET THERAPS LLC | ANDA 211590 | AP | Aug 06, 2024 | |
| ISOPROTERENOL HYDROCHLORIDE | HIKMA | ANDA 211703 | AP | Apr 26, 2023 | |
| ISOPROTERENOL HYDROCHLORIDE | ZYDUS PHARMS | ANDA 215557 | — | Apr 14, 2023 | |
| ISOPROTERENOL HYDROCHLORIDE | AM REGENT | ANDA 214775 | — | Oct 19, 2022 | |
| ISOPROTERENOL HYDROCHLORIDE | PENN LIFE | ANDA 215542 | AP | Sep 20, 2022 | |
| ISOPROTERENOL HYDROCHLORIDE | PHARMOBEDIENT | ANDA 212573 | — | Sep 06, 2022 | |
| ISOPROTERENOL HYDROCHLORIDE | AVET LIFESCIENCES | ANDA 212189 | AP | Nov 19, 2021 | |
| ISOPROTERENOL HYDROCHLORIDE | AMRING PHARMS | ANDA 211237 | AP | May 19, 2021 | |
| ISOPROTERENOL HYDROCHLORIDE | MICRO LABS | ANDA 210845 | AP | Feb 16, 2021 | |
| ISOPROTERENOL HYDROCHLORIDE | EUGIA PHARMA | ANDA 211864 | — | Feb 09, 2021 | |
| ISOPROTERENOL HYDROCHLORIDE | CIPLA | ANDA 211738 | — | Jun 28, 2019 | |
| ISOPROTERENOL HYDROCHLORIDE | AMNEAL | ANDA 210576 | AP | Oct 17, 2018 | |
| ISOPROTERENOL HYDROCHLORIDE | AMPHASTAR PHARMS INC | ANDA 210106 | AP | Jun 18, 2018 | |
| ISOPROTERENOL HYDROCHLORIDE | CIPLA | ANDA 210322 | — | Jun 12, 2018 | |
| ISOPROTERENOL HYDROCHLORIDE | NEXUS | ANDA 206961 | AP | Aug 02, 2017 | |
| ISOPROTERENOL HYDROCHLORIDE | ARMOUR PHARM | ANDA 087935 | — | Nov 18, 1982 | |
| ISOPROTERENOL HYDROCHLORIDE | ARMOUR PHARM | ANDA 087936 | — | Nov 18, 1982 | |
| ISOPROTERENOL HYDROCHLORIDE | DEY | ANDA 086764 | — | Jan 04, 1982 | |
| ISOPROTERENOL HYDROCHLORIDE | ALPHARMA US PHARMS | ANDA 085904 | — | Approved Prior to Jan 1, 1982 | |
| ISOPROTERENOL HYDROCHLORIDE | ABRAXIS PHARM | ANDA 083431 | — | Approved Prior to Jan 1, 1982 | |
| ISOPROTERENOL HYDROCHLORIDE | BAXTER HLTHCARE | ANDA 083486 | — | Approved Prior to Jan 1, 1982 | |
| ISOPROTERENOL HYDROCHLORIDE | HOSPIRA | ANDA 083283 | — | Approved Prior to Jan 1, 1982 | |
| ISOPROTERENOL HYDROCHLORIDE | HOSPIRA | ANDA 083346 | — | Approved Prior to Jan 1, 1982 | |
| ISOPROTERENOL HYDROCHLORIDE | INTL MEDICATION | ANDA 083724 | — | Approved Prior to Jan 1, 1982 | |
| ISOPROTERENOL HYDROCHLORIDE | PARKE DAVIS | ANDA 085994 | — | Approved Prior to Jan 1, 1982 | |
| ISOPROTERENOL HYDROCHLORIDE | PARKE DAVIS | ANDA 085540 | — | 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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
