FDA — authorised 10 December 1985
- Application: NDA020145
- Marketing authorisation holder: USPHARMA
- Indication: Labeling
- Status: approved
🇺🇸 NITROGLYCERIN in United States
FDA authorised NITROGLYCERIN on 10 December 1985
Marketing authorisations
FDA — authorised 24 May 1988
- Application: ANDA072034
- Marketing authorisation holder: AM REGENT
- Indication: Labeling
- Status: approved
FDA — authorised 29 December 1989
- Application: NDA019970
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 30 April 2019
- Application: ANDA211604
- Marketing authorisation holder: NATCO
- Status: approved
FDA — authorised 5 December 2023
- Application: ANDA217970
- Marketing authorisation holder: MANKIND PHARMA
- Status: approved
FDA — authorised 15 October 2024
- Application: ANDA218583
- Marketing authorisation holder: VIWIT PHARM
- Status: approved
FDA — authorised 29 November 2024
- Application: ANDA212222
- Marketing authorisation holder: TP ANDA HOLDINGS
- 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 10 December 1985; FDA authorised it on 24 May 1988; FDA authorised it on 29 December 1989.
Who is the marketing authorisation holder for NITROGLYCERIN in United States?
USPHARMA holds the US marketing authorisation.