Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062738
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL POWDER;INTRAVENOUS Prescription AP No Yes
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL POWDER;INTRAVENOUS 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
02/19/1987 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
07/31/2013 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/19/2007 SUPPL-10 Labeling

Label is not available on this site.

10/04/2004 SUPPL-5 Labeling

Label is not available on this site.

12/04/2001 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/26/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/30/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/24/1990 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

AMPICILLIN SODIUM

POWDER;INTRAVENOUS; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 062738 SANDOZ

POWDER;INTRAVENOUS; EQ 2GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 062738 SANDOZ

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