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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217409
Company: EUGIA PHARMA

Products on ANDA 217409

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	0.375G	INJECTION;POWDER,FOR SOLUTION	Prescription	None	No	No
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	3.0G	INJECTION;POWDER,FOR SOLUTION	Prescription	None	No	No
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	0.5G/1VIAL	INJECTION;POWDER,FOR SOLUTION	Prescription	None	No	No
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	4.0G	INJECTION;POWDER,FOR SOLUTION	Prescription	None	No	No
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	4.5G	INJECTION;POWDER,FOR SOLUTION	Prescription	None	No	No
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	36G	INJECTION;POWDER,FOR SOLUTION	Prescription	AP	No	No
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GMBASE/VIAL	INJECTION;POWDER,FOR SOLUTION	Prescription	None	No	No
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GMBASE/VIAL	INJECTION;POWDER,FOR SOLUTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217409

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/12/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/03/2024	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
10/12/2023	SUPPL-2			Label is not available on this site.
05/01/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 217409

PIPERACILLIN AND TAZOBACTAM

INJECTION;POWDER,FOR SOLUTION; 36G
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	36G	INJECTION;POWDER,FOR SOLUTION	Prescription	No	AP	217409	EUGIA PHARMA

PIPERACILLIN AND TAZOBACTAM

INJECTION;POWDER,FOR SOLUTION; 36G
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	36G	INJECTION;POWDER,FOR SOLUTION	Prescription	No	AP	217409	EUGIA PHARMA

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