Orange Book product · Brand (NDA)
ISUPREL
ISOPROTERENOL HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
ISOPROTERENOL HYDROCHLORIDE
Strength
0.2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 010515
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —ISOPROTERENOL HYDROCHLORIDEBrand (NDA)
NDA 010375 · 3M
- —ISUPRELBrand (NDA)
NDA 011178 · SANOFI AVENTIS US
- —NORISODRINE AEROTROLBrand (NDA)
NDA 016814 · ABBOTT
- —AEROLONEBrand (NDA)
NDA 007245 · LILLY
- —ISUPRELBrand (NDA)
NDA 006327 · SANOFI AVENTIS US
- —VAPO-ISOBrand (NDA)
NDA 016813 · FISONS
- —ISUPRELBrand (NDA)
NDA 006328 · SANOFI AVENTIS US
- 2026ISOPROTERENOL HYDROCHLORIDEGeneric (ANDA)
ANDA 220299 · ASPIRO
- 2025ISOPROTERENOL HYDROCHLORIDEGeneric (ANDA)
ANDA 213305 · DEVA HOLDING AS
- 2024ISOPROTERENOL HYDROCHLORIDEGeneric (ANDA)
ANDA 217648 · GLAND
- 2024ISOPROTERENOL HYDROCHLORIDEGeneric (ANDA)
ANDA 211590 · SOMERSET THERAPS LLC
- 2023ISOPROTERENOL HYDROCHLORIDEGeneric (ANDA)
ANDA 211703 · HIKMA
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.
