Orange Book product · Generic (ANDA)
ESMOLOL HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE
At a glance
Aug 10, 2004
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 10, 2004
22 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ESMOLOL HYDROCHLORIDE
Strength
10MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 076323
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 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
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.

