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Generated: October 17, 2018

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Details for New Drug Application (NDA): 065493

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NDA 065493 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 fifteen suppliers. Additional details are available on the AMPICILLIN SODIUM profile page.

The generic ingredient in AMPICILLIN SODIUM is ampicillin sodium. There are seventy drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.
Summary for 065493
Tradename:AMPICILLIN SODIUM
Applicant:Aurobindo Pharma
Ingredient:ampicillin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065493
Ingredient-typePenicillins
Medical Subject Heading (MeSH) Categories for 065493
Suppliers and Packaging for NDA: 065493
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 065493 ANDA AuroMedics Pharma LLC 55150-115 55150-115-99 10 VIAL, PHARMACY BULK PACKAGE in 1 BOX (55150-115-99) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:Aug 17, 2010TE:APRLD:No

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