Orange Book product · Generic (ANDA)
HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE
At a glance
Jun 02, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 02, 2025
1 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDRALAZINE HYDROCHLORIDE
Strength
20MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 217501
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HYDRALAZINE HYDROCHLORIDE
- —APRESOLINEBrand (NDA)
NDA 008303 · NOVARTIS
- 2025HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219797 · BAXTER HLTHCARE CORP
- 2024HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211010 · MACLEODS PHARMS LTD
- 2023HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215147 · EUGIA PHARMA
- 2020HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213667 · HIKMA
- 2016HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204680 · PHARMOBEDIENT
- 2015HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 203110 · PHARMOBEDIENT
- 2014HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 203845 · CADILA PHARMS LTD
- 2013HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202938 · NAVINTA LLC
- 2013HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 091679 · ACTAVIS GRP PTC
- 2012HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 200737 · ALKEM LABS LTD
- 2010HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090413 · PHARMOBEDIENT
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.
