FDA — authorised 28 May 1981
- Marketing authorisation holder: FOUGERA
- Status: approved
🇺🇸 Nitroglycerin in United States
FDA authorised Nitroglycerin on 28 May 1981
Marketing authorisations
FDA — authorised 6 October 1981
- Application: NDA018531
- Marketing authorisation holder: HOSPIRA
- Local brand name: NITROGLYCERIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 June 1986
- Application: ANDA070634
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: NITROGLYCERIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 May 1988
- Application: ANDA072034
- Marketing authorisation holder: AM REGENT
- Local brand name: NITROGLYCERIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 November 1988
- Application: ANDA089771
- Marketing authorisation holder: VALEANT PHARMS
- Local brand name: MINITRAN
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 28 November 1988
- Application: ANDA089772
- Marketing authorisation holder: VALEANT PHARMS NORTH
- Local brand name: MINITRAN
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 28 November 1988
- Application: ANDA089773
- Marketing authorisation holder: BAUSCH
- Local brand name: MINITRAN
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 28 November 1988
- Application: ANDA089774
- Marketing authorisation holder: VALEANT PHARMS
- Local brand name: MINITRAN
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 31 August 1990
- Application: ANDA071848
- Marketing authorisation holder: HOSPIRA
- Local brand name: NITROGLYCERIN IN DEXTROSE 5%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 1990
- Application: ANDA071846
- Marketing authorisation holder: HOSPIRA
- Local brand name: NITROGLYCERIN IN DEXTROSE 5%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 1990
- Application: ANDA071847
- Marketing authorisation holder: HOSPIRA
- Local brand name: NITROGLYCERIN IN DEXTROSE 5%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 August 1996
- Application: ANDA074559
- Marketing authorisation holder: MYLAN TECHNOLOGIES
- Local brand name: NITROGLYCERIN
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 2 November 2006
- Application: NDA021780
- Marketing authorisation holder: EVUS
- Local brand name: NITROMIST
- Indication: AEROSOL, METERED — SUBLINGUAL
- Status: approved
FDA — authorised 21 June 2011
- Application: NDA021359
- Marketing authorisation holder: ABBVIE
- Local brand name: RECTIV
- Indication: OINTMENT — INTRA-ANAL
- Status: approved
FDA — authorised 20 September 2013
- Application: ANDA091496
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: NITROGLYCERIN
- Indication: SPRAY, METERED — SUBLINGUAL
- Status: approved
FDA — authorised 26 August 2016
- Application: ANDA208191
- Marketing authorisation holder: DR REDDYS
- Local brand name: NITROGLYCERIN
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 19 September 2017
- Application: ANDA206391
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: NITROGLYCERIN
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 16 October 2017
- Application: ANDA203693
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: NITROGLYCERIN
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 3 May 2021
- Application: ANDA209779
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: NITROGLYCERIN
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 26 October 2023
- Application: ANDA217879
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: NITROGLYCERIN
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA — authorised 16 February 2024
- Application: ANDA216103
- Marketing authorisation holder: COSETTE
- Local brand name: NITROGLYCERIN
- Indication: OINTMENT — INTRA-ANAL
- Status: approved
FDA — authorised 16 December 2024
- Application: ANDA216452
- Marketing authorisation holder: ENCUBE
- Local brand name: NITROGLYCERIN
- Indication: OINTMENT — INTRA-ANAL
- Status: approved
FDA — authorised 15 April 2025
- Application: ANDA218235
- Marketing authorisation holder: ENCUBE
- Local brand name: NITROGLYCERIN
- Indication: OINTMENT — TRANSDERMAL
- Status: approved
FDA — authorised 18 December 2025
- Application: ANDA218756
- Marketing authorisation holder: SOLARIS PHARMA CORP
- Local brand name: NITROGLYCERIN
- Indication: OINTMENT — INTRA-ANAL
- Status: approved
FDA
- Application: ANDA040048
- Marketing authorisation holder: NOVEN
- Local brand name: NITROGLYCERIN
- Indication: Film, Extended Release — Transdermal
- Status: approved
FDA
- Application: ANDA040049
- Marketing authorisation holder: NOVEN
- Local brand name: NITROGLYCERIN
- Indication: Film, Extended Release — Transdermal
- Status: approved
FDA
- Application: ANDA071094
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: NITROGLYCERIN
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA040047
- Marketing authorisation holder: NOVEN
- Local brand name: NITROGLYCERIN
- Indication: Film, Extended Release — Transdermal
- Status: approved
FDA
- Application: ANDA070026
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: NITROGLYCERIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070633
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: NITROGLYCERIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070077
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: NITROGLYCERIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071095
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: NITROGLYCERIN
- Indication: Injectable — Injection
- Status: approved
Nitroglycerin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Nitroglycerin approved in United States?
Yes. FDA authorised it on 28 May 1981; FDA authorised it on 6 October 1981; FDA authorised it on 19 June 1986.
Who is the marketing authorisation holder for Nitroglycerin in United States?
FOUGERA holds the US marketing authorisation.