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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205043
Company: ACS DOBFAR SPA

Products on ANDA 205043

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205043

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 205043

PENICILLIN G POTASSIUM

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

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