Penicillin G Benzathine

Generic Name: Penicillin G Benzathine

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Long-term Follow up Study for Patients Who Participated in the GOAL Trial (GOAL-Post)	2022/01/27	NCT05211024	N/A	Completed	Children's Hospital Medical Center, Cincinnati
A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects	2018/08/02	NCT03612557	Phase 1	Completed	Pfizer

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
BICILLIN L-A	A-S Medication Solutions	50090-1666	INTRAMUSCULAR	600000 [iU] in 1 mL	9/12/2023
BICILLIN CR	Dispensing Solutions, Inc.	68258-8910	INTRAMUSCULAR	600000 [iU] in 2 mL	10/29/2013
BICILLIN C-R 900/300	Pfizer Laboratories Div Pfizer Inc	60793-602	INTRAMUSCULAR	900000 [iU] in 2 mL	9/12/2023
BICILLIN L-A	Pfizer Laboratories Div Pfizer Inc	60793-702	INTRAMUSCULAR	2400000 [iU] in 4 mL	9/12/2023
BICILLIN CR	Pfizer Laboratories Div Pfizer Inc	60793-600	INTRAMUSCULAR	600000 [iU] in 2 mL	9/12/2023
BICILLIN L-A	NuCare Pharmaceuticals,Inc.	68071-1824	INTRAMUSCULAR	1200000 [iU] in 2 mL	1/17/2024
BICILLIN L-A	Pfizer Laboratories Div Pfizer Inc	60793-701	INTRAMUSCULAR	1200000 [iU] in 2 mL	9/12/2023
EXTENCILLINE	Provepharm Inc.	81284-523	INTRAMUSCULAR	1200000 [iU] in 1 1	12/13/2023
BICILLIN L-A	A-S Medication Solutions	50090-1016	INTRAMUSCULAR	1200000 [iU] in 2 mL	9/12/2023
BICILLIN CR	Pfizer Laboratories Div Pfizer Inc	60793-601	INTRAMUSCULAR	600000 [iU] in 2 mL	9/12/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
BICILLIN L-A benzathine benzylpenicillin tetrahydrate 1,200,000 Units / 2.3 mL suspension for injection pre-filled syringe with needle	147169	Pfizer Australia Pty Ltd	Medicine	A	1/3/2008
BICILLIN L-A-benzathine benzylpenicillin tetrahydrate 600,000 units/1.17 mL suspension for injection syringe with needle	293456	Pfizer Australia Pty Ltd	Medicine	A	9/19/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
BICILLIN L-A	Pfizer Canada Ulc	02291924	Suspension - Intramuscular	1200000 UNIT / 2 ML	6/11/2008
MEGACILLIN 500 SUS	merck frosst canada & cie, merck frosst canada & co.	00009938	Suspension - Oral	500000 UNIT / 5 ML	12/31/1961
MEGACILLIN 250 PEDI SUS	merck frosst canada & cie, merck frosst canada & co.	00107441	Suspension - Oral	250000 UNIT / 5 ML	12/31/1959
BICILLIN L-A INJECTION SUS 1200000IU/2ML	wyeth-ayerst canada inc.	02041596	Suspension - Intramuscular	1200000 UNIT / 2 ML	12/31/1994
BICILLIN A-P INJECTION PWS	wyeth-ayerst canada inc.	02041588	Powder For Solution - Intramuscular	600000 UNIT / 2 ML	12/31/1995

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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