Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065386
Company: HOSPIRA INC

Products on ANDA 065386

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065386

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/2009	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065386lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065386s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/23/2017	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/23/2017	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/23/2017	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/23/2017	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
10/23/2017	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/23/2017	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 065386

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065386lbl.pdf