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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200002
Company: ONESOURCE SPECIALTY

Products on ANDA 200002

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200002

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/07/2014	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Therapeutic Equivalents for ANDA 200002

NAFCILLIN SODIUM

INJECTABLE;INJECTION; EQ 1GM 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 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090560	ANTIBIOTICE
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091613	EUGIA PHARMA SPECLTS
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090002	ISTITUTO BIO ITA SPA
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	200002	ONESOURCE SPECIALTY
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090582	SAGENT PHARMS

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
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090560	ANTIBIOTICE
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	091613	EUGIA PHARMA SPECLTS
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090002	ISTITUTO BIO ITA SPA
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	200002	ONESOURCE SPECIALTY
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090582	SAGENT PHARMS

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