Orange Book product · Generic (ANDA)
HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE
At a glance
Apr 21, 2009
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 21, 2009
17 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDRALAZINE HYDROCHLORIDE
Strength
20MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 040730
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 215147 · EUGIA PHARMA
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ANDA 213667 · HIKMA
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ANDA 204680 · PHARMOBEDIENT
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ANDA 203110 · PHARMOBEDIENT
- 2014HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 203845 · CADILA PHARMS LTD
- 2013HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 202938 · NAVINTA LLC
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ANDA 091679 · ACTAVIS GRP PTC
- 2012HYDRALAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 200737 · ALKEM LABS LTD
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.
