FDA Orange Book · active-ingredient family
Isoetharine hydrochloride
Isoetharine hydrochloride is approved as 1 brand and 34 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BRONKOSOL · NDA 012339
1
Brand (NDA)
34
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BRONKOSOL×2 | SANOFI AVENTIS US | NDA 012339 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (34)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ISOETHARINE HYDROCHLORIDE | ASTRAZENECA | ANDA 089614 | — | Jun 13, 1991 | |
| ISOETHARINE HYDROCHLORIDE | ASTRAZENECA | ANDA 089615 | — | Jun 13, 1991 | |
| ISOETHARINE HYDROCHLORIDE | ASTRAZENECA | ANDA 089616 | — | Jun 13, 1991 | |
| ISOETHARINE HYDROCHLORIDE | ASTRAZENECA | ANDA 089617 | — | Jun 13, 1991 | |
| ISOETHARINE HYDROCHLORIDE | ASTRAZENECA | ANDA 089618 | — | Jun 13, 1991 | |
| ISOETHARINE HYDROCHLORIDE S/F | DEY | ANDA 089817 | — | Nov 22, 1988 | |
| ISOETHARINE HYDROCHLORIDE S/F | DEY | ANDA 089818 | — | Nov 22, 1988 | |
| ISOETHARINE HYDROCHLORIDE S/F | DEY | ANDA 089819 | — | Nov 22, 1988 | |
| ISOETHARINE HYDROCHLORIDE S/F | DEY | ANDA 089820 | — | Nov 22, 1988 | |
| ISOETHARINE HYDROCHLORIDE S/F | DEY | ANDA 089252 | — | Sep 15, 1986 | |
| ISOETHARINE HYDROCHLORIDE | BAXTER HLTHCARE | ANDA 088145 | — | Mar 26, 1984 | |
| ISOETHARINE HYDROCHLORIDERLD | ASTRAZENECA | ANDA 088470 | — | Mar 14, 1984 | |
| ISOETHARINE HYDROCHLORIDERLD | ASTRAZENECA | ANDA 088471 | — | Mar 14, 1984 | |
| ISOETHARINE HYDROCHLORIDERLD | ASTRAZENECA | ANDA 088472 | — | Mar 14, 1984 | |
| ISOETHARINE HYDROCHLORIDE | ROXANE | ANDA 088226 | — | Sep 16, 1983 | |
| ISOETHARINE HYDROCHLORIDE | BAXTER HLTHCARE | ANDA 088146 | — | Aug 01, 1983 | |
| ISOETHARINE HYDROCHLORIDE | BAXTER HLTHCARE | ANDA 088144 | — | Jul 29, 1983 | |
| ISOETHARINE HYDROCHLORIDE | ROXANE | ANDA 088275 | — | Jun 03, 1983 | |
| ISOETHARINE HYDROCHLORIDE | DEY | ANDA 088187 | — | Dec 03, 1982 | |
| ISOETHARINE HYDROCHLORIDE | DEY | ANDA 088188 | — | Dec 03, 1982 | |
| ISOETHARINE HYDROCHLORIDERLD | ASTRAZENECA | ANDA 087937 | — | Nov 15, 1982 | |
| ISOETHARINE HYDROCHLORIDERLD | ASTRAZENECA | ANDA 087938 | — | Nov 15, 1982 | |
| BETA-2 | NEPHRON | ANDA 086711 | — | Approved Prior to Jan 1, 1982 | |
| ISOETHARINE HYDROCHLORIDE | ALPHARMA US PHARMS | ANDA 087101 | — | Approved Prior to Jan 1, 1982 | |
| ISOETHARINE HYDROCHLORIDE | DEY | ANDA 087389 | — | Approved Prior to Jan 1, 1982 | |
| ISOETHARINE HYDROCHLORIDE | DEY | ANDA 087390 | — | Approved Prior to Jan 1, 1982 | |
| ISOETHARINE HYDROCHLORIDERLD | DEY | ANDA 086763 | — | Approved Prior to Jan 1, 1982 | |
| ISOETHARINE HYDROCHLORIDE×8 | INTL MEDICATION | ANDA 086651 | — | Approved Prior to Jan 1, 1982 | |
| ISOETHARINE HYDROCHLORIDE | PARKE DAVIS | ANDA 085997 | — | Approved Prior to Jan 1, 1982 | |
| ISOETHARINE HYDROCHLORIDE | PARKE DAVIS | ANDA 085889 | — | Approved Prior to Jan 1, 1982 | |
| ISOETHARINE HYDROCHLORIDE | ROXANE | ANDA 087396 | — | Approved Prior to Jan 1, 1982 | |
| ISOETHARINE HYDROCHLORIDE | ROXANE | ANDA 087025 | — | Approved Prior to Jan 1, 1982 | |
| ISOETHARINE HYDROCHLORIDE | ROXANE | ANDA 087324 | — | Approved Prior to Jan 1, 1982 | |
| ISOETHARINE HYDROCHLORIDE | ROXANE | ANDA 086899 | — | 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.
Isoetharine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
