An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 060657
Company: PFIZER

Products on ANDA 060657

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PFIZERPEN	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	No	No
PFIZERPEN	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes
PFIZERPEN	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 060657

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/1968	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2018	SUPPL-28	Labeling-Container/Carton Labels		Label is not available on this site.
07/21/2016	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
09/26/2014	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
05/20/2015	SUPPL-19	Labeling-Container/Carton Labels		Label is not available on this site.
05/15/2010	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
09/16/2004	SUPPL-14	Labeling		Label is not available on this site.
07/14/1994	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
02/01/1994	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/03/1989	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/12/1991	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 060657

PFIZERPEN

INJECTABLE;INJECTION; 5,000,000 UNITS/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205043	ACS DOBFAR SPA
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065149	HQ SPECLT PHARMA
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065448	ISTITUTO BIO ITA SPA
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065079	SANDOZ
PFIZERPEN	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	060657	PFIZER

INJECTABLE;INJECTION; 20,000,000 UNITS/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205043	ACS DOBFAR SPA
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065149	HQ SPECLT PHARMA
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065448	ISTITUTO BIO ITA SPA
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065079	SANDOZ
PFIZERPEN	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	060657	PFIZER

Top