Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201404
Company: ISTITUTO BIO ITA SPA

Products on ANDA 201404

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201404

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2013	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2018	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
02/15/2018	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201404

AMPICILLIN 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
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090889	ACS DOBFAR SPA
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065493	EUGIA PHARMA SPECLTS
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	063142	HQ SPECLT PHARMA
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	201404	ISTITUTO BIO ITA SPA
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090581	SAGENT PHARMS INC
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	061395	SANDOZ
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	202198	STERISCIENCE