Orange Book product · Brand (NDA)
DIGOXIN
DIGOXIN
At a glance
Aug 26, 2004
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 26, 2004
22 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
DIGOXIN
Strength
0.05MG/ML
Dosage form
ELIXIR
Route
ORAL
TE code
AA
Application
NDA 021648
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 1997LANOXINBrand (NDA)
NDA 020405 · ADVANZ PHARMA
- 1982LANOXICAPSBrand (NDA)
NDA 018118 · GLAXOSMITHKLINE LLC
- —LANOXINBrand (NDA)
NDA 009330 · AZURITY
- 2022DIGOXINGeneric (ANDA)
ANDA 215307 · NOVITIUM PHARMA
- 2022DIGOXINGeneric (ANDA)
ANDA 215209 · AMICI PHARMA
- 2022DIGOXINGeneric (ANDA)
ANDA 214982 · AUROBINDO PHARMA LTD
- 2019DIGOXINGeneric (ANDA)
ANDA 213000 · VISTAPHARM LLC
- 2009DIGOXINGeneric (ANDA)
ANDA 078556 · IMPAX LABS
- 2007DIGOXINGeneric (ANDA)
ANDA 077002 · HIKMA INTL PHARMS
- 2003DIGOXINGeneric (ANDA)
ANDA 040481 · SANDOZ
- 2003DIGOXINGeneric (ANDA)
ANDA 076363 · SUN PHARM INDS INC
- 2002DIGOXINGeneric (ANDA)
ANDA 076268 · STEVENS J
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.
