FDA — authorised 14 February 1997
- Application: ANDA040148
- Marketing authorisation holder: APIL
- Local brand name: NORCO
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Hydrocodone-Acetaminophen Tab 5-325 MG in United States
FDA authorised Hydrocodone-Acetaminophen Tab 5-325 MG on 14 February 1997
Marketing authorisations
FDA — authorised 25 June 1997
- Application: ANDA040099
- Marketing authorisation holder: APIL
- Local brand name: NORCO
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Hydrocodone-Acetaminophen Tab 5-325 MG 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 Hydrocodone-Acetaminophen Tab 5-325 MG approved in United States?
Yes. FDA authorised it on 14 February 1997; FDA authorised it on 25 June 1997; FDA has authorised it.
Who is the marketing authorisation holder for Hydrocodone-Acetaminophen Tab 5-325 MG in United States?
APIL holds the US marketing authorisation.