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Data updated: Jul 17, 2026

BICILLIN C-R (penicillin g benzathine) · KING PHARMS LLC

Infectious Disease Approved 1953-05-18
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
73
Years on Market

Details

Status
Discontinued
First Approved
1953-05-18
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

KING PHARMS LLC
Active Ingredient: PENICILLIN G BENZATHINE , PENICILLIN G PROCAINE

BICILLIN C-R Approval History

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Original
New Indication
New Form
Label Update
462 FDA actions from 1953 to 2026
Jun 2026 SUPPL
Label · Labeling
FDA Letter Label
Dec 2020 SUPPL
Label · Labeling
FDA Letter Label
Dec 2020 SUPPL
Label · Labeling
FDA Letter Label

What BICILLIN C-R Treats

1 FDA approvals

Originally approved for its first indication in 1953 .

  • Other (1)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03612557 B8441001 Ph 1 completed A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BICILLIN C-R FDA Label Details

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Data Sources

FDA Approval: NDA050138 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.