Orange Book product · Generic (ANDA)
HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE
At a glance
Mar 04, 2013
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 04, 2013
13 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDRALAZINE HYDROCHLORIDE
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 091679
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HYDRALAZINE HYDROCHLORIDE
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ANDA 211010 · MACLEODS PHARMS LTD
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ANDA 215147 · EUGIA PHARMA
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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
- 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.
