Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062527
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/02/1984 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
01/04/2016 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

01/04/2016 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

01/04/2016 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

01/04/2016 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

01/04/2016 SUPPL-24 Labeling

Label is not available on this site.

09/30/2004 SUPPL-17 Labeling

Label is not available on this site.

08/26/1998 SUPPL-13 Labeling

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 200002 MYLAN LABS LTD
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 200002 MYLAN LABS LTD
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

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 AUROBINDO PHARMA LTD
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
NAFCILLIN SODIUM NAFCILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062527 SANDOZ

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English