Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090002
Company: ISTITUTO BIO ITA SPA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/30/2011 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
03/08/2018 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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 AUROBINDO PHARMA LTD
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 062527 SANDOZ
NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062732 SANDOZ

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 AUROBINDO PHARMA LTD
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 062527 SANDOZ
NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062732 SANDOZ

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