FDA — authorised 20 December 1972
- Application: ANDA083154
- Marketing authorisation holder: ABBOTT
- Status: approved
🇺🇸 "Local Anesthetic", "Epinephrine", "Morphine" and "Surgicel" in United States
FDA authorised "Local Anesthetic", "Epinephrine", "Morphine" and "Surgicel" on 20 December 1972
Marketing authorisations
FDA — authorised 28 August 1981
- Application: ANDA086173
- Marketing authorisation holder: FOSUN PHARMA
- Status: supplemented
FDA — authorised 12 December 2001
- Application: NDA018854
- Marketing authorisation holder: WATSON LABS
- Indication: Labeling
- Status: approved
FDA — authorised 17 September 2010
- Application: ANDA079025
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
FDA — authorised 21 December 2011
- Application: ANDA090653
- Marketing authorisation holder: HOSPIRA INC
- Status: approved
FDA — authorised 26 June 2012
- Application: ANDA090979
- Marketing authorisation holder: PADAGIS ISRAEL
- Status: approved
FDA — authorised 8 February 2013
- Application: ANDA202323
- Marketing authorisation holder: ACCORD HLTHCARE
- Status: approved
FDA — authorised 21 January 2022
- Application: ANDA205762
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 7 June 2023
- Application: ANDA204169
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 29 August 2023
- Application: ANDA204552
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Indication: Labeling
- Status: approved
"Local Anesthetic", "Epinephrine", "Morphine" and "Surgicel" 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 "Local Anesthetic", "Epinephrine", "Morphine" and "Surgicel" approved in United States?
Yes. FDA authorised it on 20 December 1972; FDA authorised it on 28 August 1981; FDA authorised it on 12 December 2001.
Who is the marketing authorisation holder for "Local Anesthetic", "Epinephrine", "Morphine" and "Surgicel" in United States?
ABBOTT holds the US marketing authorisation.