Orange Book product · Generic (ANDA)
VARDENAFIL HYDROCHLORIDE
VARDENAFIL HYDROCHLORIDE
At a glance
Nov 16, 2018
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 16, 2018
7 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
VARDENAFIL HYDROCHLORIDE
Strength
10MG
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
AB
Application
ANDA 208324
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of VARDENAFIL HYDROCHLORIDE
- 2010STAXYNBrand (NDA)
NDA 200179 · BAYER HLTHCARE
- 2003LEVITRABrand (NDA)
NDA 021400 · BAYER HLTHCARE
- 2020VARDENAFIL HYDROCHLORIDEGeneric (ANDA)
ANDA 214031 · ALEMBIC
- 2020VARDENAFIL HYDROCHLORIDEGeneric (ANDA)
ANDA 205988 · MACLEODS PHARMS LTD
- 2019VARDENAFIL HYDROCHLORIDEGeneric (ANDA)
ANDA 204632 · MACLEODS PHARMS LTD
- 2018VARDENAFIL HYDROCHLORIDEGeneric (ANDA)
ANDA 209057 · CROSSMEDIKA SA
- 2018VARDENAFIL HYDROCHLORIDEGeneric (ANDA)
ANDA 210738 · STEVENS J
- 2018VARDENAFIL HYDROCHLORIDEGeneric (ANDA)
ANDA 208960 · ZYDUS PHARMS
- 2012VARDENAFIL HYDROCHLORIDEGeneric (ANDA)
ANDA 091347 · TEVA PHARMS
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.
