Orange Book product · Brand (NDA)
LANOXIN PEDIATRIC
DIGOXIN
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
DIGOXIN
Strength
0.1MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 009330
Product number
004
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.
- 2004DIGOXINBrand (NDA)
NDA 021648 · HIKMA
- 1997LANOXINBrand (NDA)
NDA 020405 · ADVANZ PHARMA
- 1982LANOXICAPSBrand (NDA)
NDA 018118 · GLAXOSMITHKLINE LLC
- 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.
