FDA — authorised 21 August 1981
- Application: ANDA087508
- Marketing authorisation holder: GENUS LIFESCIENCES
- Status: supplemented
🇺🇸 Acetaminophen and Codeine in United States
FDA authorised Acetaminophen and Codeine on 21 August 1981
Marketing authorisations
FDA — authorised 30 September 1988
- Application: ANDA089990
- Marketing authorisation holder: STRIDES PHARMA INTL
- Indication: Labeling
- Status: approved
FDA — authorised 22 June 2011
- Application: ANDA089828
- Marketing authorisation holder: STRIDES PHARMA INTL
- Indication: Labeling
- Status: approved
FDA — authorised 15 April 2013
- Application: ANDA202800
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Indication: Labeling
- Status: approved
FDA — authorised 27 June 2019
- Application: ANDA211610
- Marketing authorisation holder: HIBROW HLTHCARE
- Indication: Labeling
- Status: approved
FDA — authorised 10 September 2019
- Application: ANDA212418
- Marketing authorisation holder: ELITE LABS INC
- Status: supplemented
FDA — authorised 7 October 2019
- Application: ANDA089805
- Marketing authorisation holder: STRIDES PHARMA INTL
- Indication: Labeling
- Status: approved
Acetaminophen and Codeine 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 Acetaminophen and Codeine approved in United States?
Yes. FDA authorised it on 21 August 1981; FDA authorised it on 30 September 1988; FDA authorised it on 22 June 2011.
Who is the marketing authorisation holder for Acetaminophen and Codeine in United States?
GENUS LIFESCIENCES holds the US marketing authorisation.