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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090498
Company: ISTITUTO BIO ITA SPA

Products on ANDA 090498

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	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090498

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/2011	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
05/01/2024	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
12/12/2023	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
11/23/2022	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
11/23/2022	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
05/29/2020	SUPPL-17	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/29/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
05/29/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
05/29/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/29/2020	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/09/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/25/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090498

PIPERACILLIN AND TAZOBACTAM

INJECTABLE;INJECTION; EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203720	FRESENIUS KABI
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090498	ISTITUTO BIO ITA SPA
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207848	PROVEPHARM SAS
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	208675	SAGENT PHARMS INC
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	203557	SANDOZ
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	217243	SHANDONG
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207146	WOCKHARDT BIO AG

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