FDA Orange Book · active-ingredient family
Digoxin
Digoxin is approved as 4 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DIGOXIN · NDA 021648
4
Brand (NDA)
16
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, elixir, injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIGOXINRLD | HIKMA | NDA 021648 | AA | Aug 26, 2004 | |
| LANOXINRLD×6 | ADVANZ PHARMA | NDA 020405 | AB | Sep 30, 1997 | |
| LANOXINRLD×2 | AZURITY | NDA 009330 | AP | Approved Prior to Jan 1, 1982 | |
| LANOXICAPS×4 | GLAXOSMITHKLINE LLC | NDA 018118 | — | Jul 26, 1982 |
Generic (ANDA) products (16)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIGOXIN×3 | NOVITIUM PHARMA | ANDA 215307 | AB | Aug 25, 2022 | |
| DIGOXIN | AMICI PHARMA | ANDA 215209 | AA | Mar 11, 2022 | |
| DIGOXIN×3 | AUROBINDO PHARMA LTD | ANDA 214982 | AB | Feb 08, 2022 | |
| DIGOXIN | VISTAPHARM LLC | ANDA 213000 | AA | Oct 04, 2019 | |
| DIGOXIN×2 | IMPAX LABS | ANDA 078556 | — | Jul 20, 2009 | |
| DIGOXIN×2 | HIKMA INTL PHARMS | ANDA 077002 | AB | Oct 30, 2007 | |
| DIGOXIN | SANDOZ | ANDA 040481 | AP | Aug 21, 2003 | |
| DIGOXIN×2 | SUN PHARM INDS INC | ANDA 076363 | — | Jan 31, 2003 | |
| DIGOXIN×2 | STEVENS J | ANDA 076268 | AB | Jul 26, 2002 | |
| DIGOXIN×2 | RISING | ANDA 040282 | AB | Dec 23, 1999 | |
| DIGOXIN | HOSPIRA | ANDA 040206 | — | Aug 28, 1998 | |
| DIGOXIN | HOSPIRA | ANDA 040093 | — | May 16, 1996 | |
| DIGOXIN PEDIATRIC | HOSPIRA | ANDA 040092 | — | Apr 25, 1996 | |
| DIGOXIN | ABRAXIS PHARM | ANDA 083217 | — | Approved Prior to Jan 1, 1982 | |
| DIGOXIN | HIKMA | ANDA 083391 | AP | Approved Prior to Jan 1, 1982 | |
| DIGOXIN | WYETH AYERST | ANDA 084386 | — | Approved Prior to Jan 1, 1982 |
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.
Digoxin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
