FDA — authorised 15 October 1986
- Application: NDA019462
- Marketing authorisation holder: BAUSCH
- Local brand name: PEPCID
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Cetirizine and Famotidine in United States
FDA authorised Cetirizine and Famotidine on 15 October 1986
Marketing authorisations
FDA — authorised 4 November 1986
- Application: NDA019510
- Marketing authorisation holder: MERCK
- Local brand name: PEPCID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 February 1987
- Application: NDA019527
- Marketing authorisation holder: SALIX PHARMS
- Local brand name: PEPCID
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 27 September 1996
- Application: NDA020346
- Marketing authorisation holder: J AND J CONSUMER INC
- Local brand name: ZYRTEC
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Status: approved
Cetirizine and Famotidine 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 Cetirizine and Famotidine approved in United States?
Yes. FDA authorised it on 15 October 1986; FDA authorised it on 4 November 1986; FDA authorised it on 2 February 1987.
Who is the marketing authorisation holder for Cetirizine and Famotidine in United States?
BAUSCH holds the US marketing authorisation.