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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062797
Company: ISTITUTO BIO ITA SPA

Products on ANDA 062797

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 125MG BASE/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062797

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/12/1993	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-13	Labeling-Package Insert		Label is not available on this site.
02/15/2018	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
02/15/2018	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
02/15/2018	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
06/25/2004	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 062797

AMPICILLIN SODIUM

INJECTABLE;INJECTION; EQ 2GM 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 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090354	ANTIBIOTICE
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065499	EUGIA PHARMA SPECLTS
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	062772	HQ SPECLT PHARMA
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	062797	ISTITUTO BIO ITA SPA
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090583	SAGENT PHARMS INC
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	061395	SANDOZ
AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	201025	STERISCIENCE

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