FDA — authorised 26 April 1948
- Application: ANDA060101
- Marketing authorisation holder: KING PHARMS LLC
- Local brand name: PENICILLIN G PROCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 PENICILLIN G PROCAINE in United States
FDA authorised PENICILLIN G PROCAINE on 26 April 1948 · 374 US adverse-event reports
Marketing authorisations
FDA — authorised 10 November 1948
- Application: ANDA060099
- Marketing authorisation holder: PFIZER
- Local brand name: PENICILLIN G PROCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 November 1950
- Application: ANDA060286
- Marketing authorisation holder: PFIZER
- Local brand name: PFIZERPEN-AS
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 May 1965
- Application: NDA050138
- Marketing authorisation holder: KING PHARMS LLC
- Indication: Labeling
- Status: approved
FDA
- Application: ANDA062029
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: PENICILLIN G PROCAINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA060800
- Marketing authorisation holder: CONSOLIDATED PHARM
- Local brand name: PENICILLIN G PROCAINE
- Indication: INJECTABLE — INJECTION
- 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: 374
Most-reported reactions
- Drug Hypersensitivity — 198 reports (52.94%)
- Hypersensitivity — 41 reports (10.96%)
- Rash — 29 reports (7.75%)
- Urticaria — 23 reports (6.15%)
- Drug Intolerance — 17 reports (4.55%)
- White Blood Cell Count Decreased — 17 reports (4.55%)
- Rheumatoid Arthritis — 16 reports (4.28%)
- Anaphylactic Reaction — 14 reports (3.74%)
- Sleep Disorder Due To General Medical Condition, Insomnia Type — 10 reports (2.67%)
- Chest Discomfort — 9 reports (2.41%)
PENICILLIN G PROCAINE 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 PROCAINE approved in United States?
Yes. FDA authorised it on 26 April 1948; FDA authorised it on 10 November 1948; FDA authorised it on 1 November 1950.
Who is the marketing authorisation holder for PENICILLIN G PROCAINE in United States?
KING PHARMS LLC holds the US marketing authorisation.