FDA — authorised 1 September 1977
- Marketing authorisation holder: GD SEARLE LLC
- Status: approved
🇺🇸 Norpace Cr in United States
FDA authorised Norpace Cr on 1 September 1977
Marketing authorisations
FDA — authorised 23 November 1979
- Application: NDA017447
- Marketing authorisation holder: PFIZER
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 20 July 1982
- Application: NDA018655
- Marketing authorisation holder: PFIZER
- Local brand name: NORPACE CR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 November 1997
- Application: ANDA070173
- Marketing authorisation holder: DR REDDYS LABS SA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 16 May 2000
- Application: ANDA070101
- Marketing authorisation holder: TEVA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 29 April 2015
- Application: ANDA070102
- Marketing authorisation holder: TEVA
- Indication: Labeling
- Status: approved
Norpace Cr 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 Norpace Cr approved in United States?
Yes. FDA authorised it on 1 September 1977; FDA authorised it on 23 November 1979; FDA authorised it on 20 July 1982.
Who is the marketing authorisation holder for Norpace Cr in United States?
GD SEARLE LLC holds the US marketing authorisation.