FDA — authorised 7 May 1965
- Application: NDA050138
- Marketing authorisation holder: KING PHARMS LLC
- Indication: Labeling
- Status: approved
🇺🇸 PENICILLIN G BENZATHINE in United States
FDA authorised PENICILLIN G BENZATHINE on 7 May 1965 · 321 US adverse-event reports
Marketing authorisations
FDA — authorised 3 May 1988
- Application: NDA050141
- Marketing authorisation holder: KING PHARMS LLC
- Indication: Manufacturing (CMC)
- 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: 321
Most-reported reactions
- Drug Hypersensitivity — 112 reports (34.89%)
- Embolia Cutis Medicamentosa — 33 reports (10.28%)
- Hypersensitivity — 29 reports (9.03%)
- Drug Ineffective — 27 reports (8.41%)
- Acute Kidney Injury — 26 reports (8.1%)
- Rash — 22 reports (6.85%)
- Foetal Exposure During Pregnancy — 19 reports (5.92%)
- Jarisch-Herxheimer Reaction — 18 reports (5.61%)
- Premature Baby — 18 reports (5.61%)
- Urticaria — 17 reports (5.3%)
PENICILLIN G BENZATHINE 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 PENICILLIN G BENZATHINE approved in United States?
Yes. FDA authorised it on 7 May 1965; FDA authorised it on 3 May 1988.
Who is the marketing authorisation holder for PENICILLIN G BENZATHINE in United States?
KING PHARMS LLC holds the US marketing authorisation.