Orange Book product · Brand (NDA)
APRESOLINE
HYDRALAZINE 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
HYDRALAZINE HYDROCHLORIDE
Strength
20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 008303
Product number
003
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.
- 2025HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219797 · BAXTER HLTHCARE CORP
- 2025HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217501 · KINDOS
- 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.
