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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 063142

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NDA 063142 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 seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.
Summary for 063142
Tradename:AMPICILLIN SODIUM
Applicant:Hanford Gc
Ingredient:ampicillin sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 063142
Ingredient-typePenicillins
Medical Subject Heading (MeSH) Categories for 063142
Suppliers and Packaging for NDA: 063142
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 063142 ANDA GC Hanford Manufacturing Company 10515-142 10515-142-00 10 VIAL, GLASS in 1 TRAY (10515-142-00) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 063142 ANDA Sagent Pharmaceuticals 25021-138 25021-138-99 10 BOTTLE in 1 CARTON (25021-138-99) > 100 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:Apr 15, 1993TE:APRLD:No

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