Orange Book product · Generic (ANDA)
ESMOLOL HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE
At a glance
Jul 23, 2015
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 23, 2015
11 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ESMOLOL HYDROCHLORIDE
Strength
10MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 205520
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ESMOLOL HYDROCHLORIDE
- 2016ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINERBrand (NDA)
NDA 205703 · HQ SPCLT PHARMA
- 1988BREVIBLOCBrand (NDA)
NDA 019386 · BAXTER HLTHCARE
- 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 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.

