Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218067
Company: QILU ANTIBIOTICS

Products on ANDA 218067

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERTAPENEM SODIUM	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218067

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218067

ERTAPENEM SODIUM

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERTAPENEM SODIUM	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Prescription	No	AP	208790	ACS DOBFAR SPA
ERTAPENEM SODIUM	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Prescription	No	AP	209133	EUGIA PHARMA
ERTAPENEM SODIUM	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Prescription	No	AP	212040	GLAND
ERTAPENEM SODIUM	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Prescription	No	AP	218067	QILU ANTIBIOTICS
ERTAPENEM SODIUM	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Prescription	No	AP	207647	SAVIOR LIFETEC CORP
INVANZ	ERTAPENEM SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	Prescription	Yes	AP	021337	MSD SUB MERCK