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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090354

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NDA 090354 describes AMPICILLIN SODIUM, which is a drug marketed by Acs Dobfar Spa, Antibiotice, Apothecon, Aurobindo Pharma, Consolidated Pharm, Hanford Gc, Hospira Inc, Intl Medication, Istituto Bio Ita Spa, Lilly, Mylan Labs Ltd, Sagent Pharms, Sandoz, Watson Labs Inc, and West-ward Pharms Int, and is included in twenty-five NDAs. It is available from sixteen suppliers. Additional details are available on the AMPICILLIN SODIUM profile page.

The generic ingredient in AMPICILLIN SODIUM is ampicillin sodium. There are sixty-nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.
Summary for 090354
Tradename:AMPICILLIN SODIUM
Applicant:Antibiotice
Ingredient:ampicillin sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 090354
Ingredient-typePenicillins
Medical Subject Heading (MeSH) Categories for 090354
Suppliers and Packaging for NDA: 090354
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 090354 ANDA C.O. Truxton, Inc. 0463-1118 E 0463-1118-11
AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 090354 ANDA Sagent Pharmaceuticals 25021-134 N 25021-134-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL
Approval Date:Dec 28, 2009TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Dec 28, 2009TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Dec 28, 2009TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
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Covington
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Merck
Chubb
McKesson
Argus Health
Daiichi Sankyo

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