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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091614
Company: EUGIA PHARMA SPECLTS

Products on ANDA 091614

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091614

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/26/2012	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 091614

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	090005	ISTITUTO BIO ITA SPA
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 10GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090580	SAGENT PHARMS

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