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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090582
Company: SAGENT PHARMS

Products on ANDA 090582

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	AP	No	No
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090582

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/24/2012	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
02/11/2021	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/11/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
02/11/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090582

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	090582	SAGENT PHARMS
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	200002	STERISCIENCE

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	090582	SAGENT PHARMS
NAFCILLIN SODIUM	NAFCILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	200002	STERISCIENCE

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