Orange Book product · Brand (NDA)
LANOXIN
DIGOXIN
At a glance
Sep 30, 1997
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 30, 1997
29 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
DIGOXIN
Strength
0.0625MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020405
Product number
001
Marketing status
RX
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.
- 2004DIGOXINBrand (NDA)
NDA 021648 · HIKMA
- 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.
