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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 205043

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NDA 205043 describes PENICILLIN G POTASSIUM, which is a drug marketed by Mylan, Purepac Pharm, Acs Dobfar Spa, Apothecon, Consolidated Pharm, Hq Speclt Pharma, Istituto Bio Ita Spa, Lilly, Parke Davis, Pfizer, Sandoz, Watson Labs Inc, Ivax Sub Teva Pharms, Teva, Wyeth Ayerst, and Baxter Hlthcare, and is included in twenty-one NDAs. It is available from seven suppliers. Additional details are available on the PENICILLIN G POTASSIUM profile page.

The generic ingredient in PENICILLIN G POTASSIUM is penicillin g potassium. There are ninety-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the penicillin g potassium profile page.

Summary for 205043

Tradename:	PENICILLIN G POTASSIUM
Applicant:	Acs Dobfar Spa
Ingredient:	penicillin g potassium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5,000,000 UNITS/VIAL
Approval Date:	Oct 26, 2018	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	20,000,000 UNITS/VIAL
Approval Date:	Oct 26, 2018	TE:	AP	RLD:	No

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