FDA — authorised 16 November 1954
- Application: NDA009330
- Marketing authorisation holder: AZURITY
- Local brand name: LANOXIN PEDIATRIC
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 DIGOXIN in United States
FDA authorised DIGOXIN on 16 November 1954
Marketing authorisations
FDA — authorised 24 October 1975
- Application: ANDA083391
- Marketing authorisation holder: HIKMA
- Local brand name: DIGOXIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 July 1976
- Application: ANDA084386
- Marketing authorisation holder: WYETH AYERST
- Local brand name: DIGOXIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 July 1982
- Application: NDA018118
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Local brand name: LANOXICAPS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 April 1996
- Application: ANDA040092
- Marketing authorisation holder: HOSPIRA
- Local brand name: DIGOXIN PEDIATRIC
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 May 1996
- Application: ANDA040093
- Marketing authorisation holder: HOSPIRA
- Local brand name: DIGOXIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 August 1998
- Application: ANDA040206
- Marketing authorisation holder: HOSPIRA
- Local brand name: DIGOXIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 December 1999
- Application: ANDA040282
- Marketing authorisation holder: RISING
- Local brand name: DIGOXIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 July 2002
- Application: ANDA076268
- Marketing authorisation holder: STEVENS J
- Local brand name: DIGOXIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2003
- Application: ANDA076363
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: DIGOXIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 2007
- Application: ANDA077002
- Marketing authorisation holder: HIKMA INTL PHARMS
- Status: supplemented
FDA — authorised 20 July 2009
- Application: ANDA078556
- Marketing authorisation holder: IMPAX LABS
- Local brand name: DIGOXIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 October 2019
- Application: ANDA213000
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: DIGOXIN
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 22 November 2021
- Application: ANDA215307
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: DIGOXIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 February 2022
- Application: ANDA214982
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DIGOXIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 March 2022
- Application: ANDA215209
- Marketing authorisation holder: AMICI PHARMA
- Local brand name: DIGOXIN
- Indication: ELIXIR — ORAL
- Status: approved
FDA
- Application: ANDA083217
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: DIGOXIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
DIGOXIN in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is DIGOXIN approved in United States?
Yes. FDA authorised it on 16 November 1954; FDA authorised it on 24 October 1975; FDA authorised it on 12 July 1976.
Who is the marketing authorisation holder for DIGOXIN in United States?
AZURITY holds the US marketing authorisation.