FDA — authorised 9 January 1987
- Application: ANDA062693
- Marketing authorisation holder: TEVA
- Local brand name: CEPHRADINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 CEPHRADINE in United States
FDA authorised CEPHRADINE on 9 January 1987 · 175 US adverse-event reports
Marketing authorisations
FDA — authorised 9 January 1987
- Application: ANDA062683
- Marketing authorisation holder: TEVA
- Local brand name: CEPHRADINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 April 1988
- Application: ANDA062851
- Marketing authorisation holder: BARR
- Local brand name: CEPHRADINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 April 1988
- Application: ANDA062850
- Marketing authorisation holder: BARR
- Local brand name: CEPHRADINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 May 1988
- Application: ANDA062859
- Marketing authorisation holder: BARR
- Local brand name: CEPHRADINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 May 1988
- Application: ANDA062858
- Marketing authorisation holder: BARR
- Local brand name: CEPHRADINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA062762
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CEPHRADINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: NDA050548
- Marketing authorisation holder: ERSANA
- Local brand name: VELOSEF '250'
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 175
Most-reported reactions
- Asthenia — 22 reports (12.57%)
- Malaise — 22 reports (12.57%)
- Hepatotoxicity — 18 reports (10.29%)
- Constipation — 17 reports (9.71%)
- Depressed Level Of Consciousness — 17 reports (9.71%)
- Gait Inability — 17 reports (9.71%)
- Hepatic Failure — 16 reports (9.14%)
- Incorrect Product Administration Duration — 16 reports (9.14%)
- Asthenopia — 15 reports (8.57%)
- Consciousness Fluctuating — 15 reports (8.57%)
CEPHRADINE 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 CEPHRADINE approved in United States?
Yes. FDA authorised it on 9 January 1987; FDA authorised it on 9 January 1987; FDA authorised it on 22 April 1988.
Who is the marketing authorisation holder for CEPHRADINE in United States?
TEVA holds the US marketing authorisation.