FDA — authorised 22 October 1986
- Application: NDA019523
- Marketing authorisation holder: HOSPIRA
- Local brand name: CYSTEINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Cysteine Hydrochloride in United States
FDA authorised Cysteine Hydrochloride on 22 October 1986
Marketing authorisations
FDA — authorised 22 October 1986
- Marketing authorisation holder: HOSPIRA
- Status: approved
FDA — authorised 7 September 1988
- Application: NDA019018
- Marketing authorisation holder: B BRAUN
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 23 August 2004
- Application: ANDA075880
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 16 April 2019
- Application: NDA210660
- Marketing authorisation holder: EXELA PHARMA
- Local brand name: ELCYS
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 13 December 2019
- Application: NDA212535
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: NOURESS
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA214082
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: CYSTEINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Cysteine Hydrochloride in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is Cysteine Hydrochloride approved in United States?
Yes. FDA authorised it on 22 October 1986; FDA authorised it on 22 October 1986; FDA authorised it on 7 September 1988.
Who is the marketing authorisation holder for Cysteine Hydrochloride in United States?
HOSPIRA holds the US marketing authorisation.