Orange Book product · Generic (ANDA)
HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE
At a glance
Jul 17, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 17, 2025
11 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDRALAZINE HYDROCHLORIDE
Strength
20MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 219797
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
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ANDA 213667 · HIKMA
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ANDA 204680 · PHARMOBEDIENT
- 2015HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 203110 · PHARMOBEDIENT
- 2014HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 203845 · CADILA PHARMS LTD
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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.
