Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065114
Company: ISTITUTO BIO ITA SPA

Products on ANDA 065114

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PIPERACILLIN	PIPERACILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	None	No	Yes
PIPERACILLIN	PIPERACILLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	None	No	Yes
PIPERACILLIN	PIPERACILLIN SODIUM	EQ 4GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065114

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/14/2003	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-18	Labeling-Package Insert		Label is not available on this site.
03/05/2016	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
03/02/2007	SUPPL-5	Labeling		Label is not available on this site.
12/24/2003	SUPPL-1	Labeling		Label is not available on this site.