FDA — authorised 31 October 1984
- Application: ANDA088763
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Indication: SYRUP — ORAL
- Status: approved
🇺🇸 Codeine in United States
FDA authorised Codeine on 31 October 1984
Marketing authorisations
FDA — authorised 17 December 1984
- Application: ANDA088875
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 22 March 1985
- Application: ANDA088704
- Marketing authorisation holder: ANIMA
- Local brand name: TRIACIN-C
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 22 December 1988
- Application: ANDA089647
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 26 August 1997
- Application: ANDA040151
- Marketing authorisation holder: HIKMA
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 31 January 2006
- Application: ANDA040650
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: PROMETHAZINE WITH CODEINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 7 December 2006
- Application: ANDA040660
- Marketing authorisation holder: GENUS LIFESCIENCES
- Local brand name: PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 26 March 2007
- Application: ANDA089990
- Marketing authorisation holder: STRIDES PHARMA INTL
- Indication: Labeling
- Status: approved
FDA — authorised 17 March 2010
- Application: ANDA090180
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 22 June 2011
- Application: ANDA089828
- Marketing authorisation holder: STRIDES PHARMA INTL
- Indication: Labeling
- Status: approved
FDA — authorised 29 June 2012
- Application: ANDA200386
- Marketing authorisation holder: COSETTE
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 24 April 2013
- Application: ANDA200894
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 7 October 2019
- Application: ANDA089805
- Marketing authorisation holder: STRIDES PHARMA INTL
- Indication: Labeling
- Status: approved
FDA — authorised 8 October 2020
- Application: ANDA214238
- Marketing authorisation holder: QUAGEN
- Local brand name: PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
- Indication: SYRUP — ORAL
- Status: approved
Codeine 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 Codeine approved in United States?
Yes. FDA authorised it on 31 October 1984; FDA authorised it on 17 December 1984; FDA authorised it on 22 March 1985.
Who is the marketing authorisation holder for Codeine in United States?
ACTAVIS MID ATLANTIC holds the US marketing authorisation.