FDA — authorised 24 February 2005
- Application: ANDA065152
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
🇺🇸 CEPHALEXIN in United States
FDA authorised CEPHALEXIN on 24 February 2005 · 16,210 US adverse-event reports
Marketing authorisations
FDA — authorised 17 August 2005
- Application: ANDA065234
- Marketing authorisation holder: LUPIN
- Status: approved
FDA — authorised 16 November 2005
- Application: ANDA065253
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 15 September 2008
- Application: ANDA065229
- Marketing authorisation holder: LUPIN
- Indication: Labeling
- Status: approved
FDA — authorised 26 March 2019
- Application: ANDA210221
- Marketing authorisation holder: ALKEM LABS LTD
- 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: 16,210
Most-reported reactions
- Chronic Kidney Disease — 2,541 reports (15.68%)
- Acute Kidney Injury — 1,764 reports (10.88%)
- Renal Failure — 1,740 reports (10.73%)
- Diarrhoea — 1,621 reports (10%)
- Pain — 1,619 reports (9.99%)
- Fatigue — 1,484 reports (9.15%)
- Nausea — 1,453 reports (8.96%)
- Dyspnoea — 1,373 reports (8.47%)
- Anxiety — 1,312 reports (8.09%)
- Rash — 1,303 reports (8.04%)
CEPHALEXIN in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is CEPHALEXIN approved in United States?
Yes. FDA authorised it on 24 February 2005; FDA authorised it on 17 August 2005; FDA authorised it on 16 November 2005.
Who is the marketing authorisation holder for CEPHALEXIN in United States?
CHARTWELL RX holds the US marketing authorisation.