FDA Orange Book · active-ingredient family
Felodipine
Felodipine is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PLENDIL · NDA 019834
1
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PLENDILRLD×3 | ASTRAZENECA | NDA 019834 | — | Sep 22, 1994 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FELODIPINE×3 | YUNG SHIN PHARM | ANDA 204800 | AB | Apr 29, 2019 | |
| FELODIPINE×3 | YILING | ANDA 210847 | AB | Oct 26, 2018 | |
| FELODIPINE×3 | JUBILANT GENERICS | ANDA 203983 | — | Aug 19, 2016 | |
| FELODIPINE×3 | ORBION PHARMS | ANDA 203032 | AB | May 21, 2015 | |
| FELODIPINE×3 | SUN PHARM INDS LTD | ANDA 091200 | AB | Dec 13, 2013 | |
| FELODIPINE×3 | HERITAGE | ANDA 201964 | AB | Nov 08, 2013 | |
| FELODIPINE×3 | AUROBINDO PHARMA LTD | ANDA 203417 | AB | Jan 17, 2013 | |
| FELODIPINE×3 | WOCKHARDT BIO AG | ANDA 091484 | — | Aug 15, 2012 | |
| FELODIPINE×3 | TORRENT PHARMS LTD | ANDA 202170 | AB | Nov 28, 2011 | |
| FELODIPINE×3 | PH HEALTH | ANDA 200815 | AB | Oct 28, 2011 | |
| FELODIPINE×3 | GLENMARK PHARMS LTD | ANDA 090365 | AB | Dec 17, 2010 | |
| FELODIPINE×3 | MYLAN | ANDA 078855 | — | Apr 17, 2008 | |
| FELODIPINE×3 | SUN PHARM INDUSTRIES | ANDA 075896 | — | Nov 02, 2004 |
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.
Felodipine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
