Orange Book product · Generic (ANDA)
FELODIPINE
FELODIPINE
At a glance
Apr 29, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 29, 2019
7 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
FELODIPINE
Strength
2.5MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 204800
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FELODIPINE
- 1994PLENDILBrand (NDA)
NDA 019834 · ASTRAZENECA
- 2018FELODIPINEGeneric (ANDA)
ANDA 210847 · YILING
- 2016FELODIPINEGeneric (ANDA)
ANDA 203983 · JUBILANT GENERICS
- 2015FELODIPINEGeneric (ANDA)
ANDA 203032 · ORBION PHARMS
- 2013FELODIPINEGeneric (ANDA)
ANDA 091200 · SUN PHARM INDS LTD
- 2013FELODIPINEGeneric (ANDA)
ANDA 201964 · HERITAGE
- 2013FELODIPINEGeneric (ANDA)
ANDA 203417 · AUROBINDO PHARMA LTD
- 2012FELODIPINEGeneric (ANDA)
ANDA 091484 · WOCKHARDT BIO AG
- 2011FELODIPINEGeneric (ANDA)
ANDA 202170 · TORRENT PHARMS LTD
- 2011FELODIPINEGeneric (ANDA)
ANDA 200815 · PH HEALTH
- 2010FELODIPINEGeneric (ANDA)
ANDA 090365 · GLENMARK PHARMS LTD
- 2008FELODIPINEGeneric (ANDA)
ANDA 078855 · MYLAN
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.
