Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061395
Company: SANDOZ

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
AMPICILLIN SODIUM AMPICILLIN 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
03/03/1971 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
02/21/2018 SUPPL-43 Labeling-Package Insert

Label is not available on this site.
09/01/2015 SUPPL-37 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
01/25/2011 SUPPL-34 Labeling-Package Insert

Label is not available on this site.
07/17/2015 SUPPL-32 Labeling

Label is not available on this site.
10/31/2007 SUPPL-29 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
10/04/2004 SUPPL-25 Labeling

Label is not available on this site.
10/04/2004 SUPPL-24 Labeling

Label is not available on this site.
12/04/2001 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
01/23/1992 SUPPL-19 Labeling

Label is not available on this site.

AMPICILLIN SODIUM

INJECTABLE;INJECTION; EQ 125MG 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 125MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065499 AUROBINDO PHARMA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090583 SAGENT PHARMS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 061395 SANDOZ

INJECTABLE;INJECTION; EQ 250MG 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 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090354 ANTIBIOTICE
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065499 AUROBINDO PHARMA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062772 HANFORD GC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202864 HOSPIRA INC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062719 ISTITUTO BIO ITA SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 201025 MYLAN LABS LTD
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090583 SAGENT PHARMS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 061395 SANDOZ

INJECTABLE;INJECTION; EQ 500MG 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 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090884 ACS DOBFAR SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090354 ANTIBIOTICE
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065499 AUROBINDO PHARMA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062772 HANFORD GC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202864 HOSPIRA INC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062719 ISTITUTO BIO ITA SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 201025 MYLAN LABS LTD
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090583 SAGENT PHARMS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 061395 SANDOZ

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
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090884 ACS DOBFAR SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090354 ANTIBIOTICE
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065499 AUROBINDO PHARMA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062772 HANFORD GC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202864 HOSPIRA INC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062719 ISTITUTO BIO ITA SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 201025 MYLAN LABS LTD
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090583 SAGENT PHARMS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 061395 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
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090884 ACS DOBFAR SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090354 ANTIBIOTICE
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065499 AUROBINDO PHARMA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062772 HANFORD GC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202864 HOSPIRA INC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062797 ISTITUTO BIO ITA SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 201025 MYLAN LABS LTD
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090583 SAGENT PHARMS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 061395 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
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090889 ACS DOBFAR SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065493 AUROBINDO PHARMA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 063142 HANFORD GC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202865 HOSPIRA INC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 201404 ISTITUTO BIO ITA SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202198 MYLAN LABS LTD
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090581 SAGENT PHARMS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 061395 SANDOZ

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