FDA — authorised 6 July 1995
- Application: NDA020379
- Marketing authorisation holder: PFIZER
- Local brand name: CAVERJECT
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Caverject in United States
FDA authorised Caverject on 6 July 1995
Marketing authorisations
FDA — authorised 31 October 1997
- Application: NDA020755
- Marketing authorisation holder: PFIZER
- Local brand name: CAVERJECT
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 November 1999
- Application: NDA020649
- Marketing authorisation holder: ENDO OPERATIONS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 11 June 2014
- Application: NDA021212
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
FDA — authorised 19 June 2020
- Application: ANDA075196
- Marketing authorisation holder: MEITHEAL
- Indication: Labeling
- Status: approved
FDA — authorised 22 December 2025
- Application: NDA018484
- Marketing authorisation holder: PFIZER
- Indication: Labeling
- Status: approved
The FDA approved Caverject, a product of Pfizer, under the standard expedited pathway. The approval date was 22 December 2025. The application number for this approval is NDA018484. The approved indication for Caverject is listed in its labelling.
Caverject in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Caverject approved in United States?
Yes. FDA authorised it on 6 July 1995; FDA authorised it on 31 October 1997; FDA authorised it on 19 November 1999.
Who is the marketing authorisation holder for Caverject in United States?
PFIZER holds the US marketing authorisation.