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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 061395

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NDA 061395 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 fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.
Summary for 061395
Tradename:AMPICILLIN SODIUM
Applicant:Sandoz
Ingredient:ampicillin sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 061395
Ingredient-typePenicillins
Medical Subject Heading (MeSH) Categories for 061395
Suppliers and Packaging for NDA: 061395
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 061395 ANDA Hospira, Inc 0409-3718 N 0409-3718-01
AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 061395 ANDA Hospira, Inc 0409-3719 N 0409-3719-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 125MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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