Orange Book product · Brand (NDA)
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
ESMOLOL HYDROCHLORIDE
At a glance
Jan 27, 2003
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 27, 2003
23 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ESMOLOL HYDROCHLORIDE
Strength
2GM/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 019386
Product number
005
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2016ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINERBrand (NDA)
NDA 205703 · HQ SPCLT PHARMA
- 2022ESMOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 216603 · AMNEAL
- 2022ESMOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 214172 · HQ SPCLT PHARMA
- 2022ESMOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 216244 · EUGIA PHARMA
- 2019ESMOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 208538 · GLAND
- 2018ESMOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 206608 · MYLAN LABS LTD
- 2018ESMOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 207107 · SAGENT PHARMS INC
- 2015ESMOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 205520 · EUGIA PHARMA
- 2015ESMOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 201126 · AM REGENT
- 2005ESMOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 076573 · FRESENIUS KABI USA
- 2005ESMOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 076474 · MYLAN INSTITUTIONAL
- 2004ESMOLOL HYDROCHLORIDEGeneric (ANDA)
ANDA 076323 · 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.
