Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090005
Company: ISTITUTO BIO ITA SPA

Products on ANDA 090005

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090005

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/20/2011	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
07/27/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
07/27/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/27/2020	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/15/2013	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/04/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090005

NAFCILLIN SODIUM

INJECTABLE;INJECTION; EQ 10GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091614	EUGIA PHARMA SPECLTS
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	206761	FRESENIUS
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090005	ISTITUTO BIO ITA SPA
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090580	SAGENT PHARMS