FDA — authorised 20 July 1982
- Application: NDA018655
- Marketing authorisation holder: PFIZER
- Local brand name: NORPACE CR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Norpace Cr in United States
FDA authorised Norpace Cr on 20 July 1982
Marketing authorisations
FDA — authorised 22 February 1985
- Application: ANDA070102
- Marketing authorisation holder: TEVA
- Local brand name: DISOPYRAMIDE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 February 1985
- Application: ANDA070101
- Marketing authorisation holder: TEVA
- Local brand name: DISOPYRAMIDE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 December 1985
- Application: ANDA070470
- Marketing authorisation holder: RISING
- Local brand name: DISOPYRAMIDE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 December 1985
- Application: ANDA070352
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DISOPYRAMIDE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 December 1985
- Application: ANDA070351
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: DISOPYRAMIDE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070941
- Marketing authorisation holder: SUPERPHARM
- Local brand name: DISOPYRAMIDE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070940
- Marketing authorisation holder: SUPERPHARM
- Local brand name: DISOPYRAMIDE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070139
- Marketing authorisation holder: MYLAN
- Local brand name: DISOPYRAMIDE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA070138
- Marketing authorisation holder: MYLAN
- Local brand name: DISOPYRAMIDE PHOSPHATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- 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.
Frequently asked questions
Is Norpace Cr approved in United States?
Yes. FDA authorised it on 20 July 1982; FDA authorised it on 22 February 1985; FDA authorised it on 22 February 1985.
Who is the marketing authorisation holder for Norpace Cr in United States?
PFIZER holds the US marketing authorisation.