Orange Book product · Brand (NDA)
PLENDIL
FELODIPINE
At a glance
Sep 22, 1994
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 22, 1994
32 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
FELODIPINE
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 019834
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2019FELODIPINEGeneric (ANDA)
ANDA 204800 · YUNG SHIN PHARM
- 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.
