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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062738

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NDA 062738 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 062738

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 062738

Ingredient-typePenicillins

Medical Subject Heading (MeSH) Categories for 062738

Suppliers and Packaging for NDA: 062738

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN SODIUM ampicillin sodium POWDER;INTRAVENOUS 062738 ANDA Sandoz Inc 0781-3412 0781-3412-92 10 VIAL, GLASS in 1 PACKAGE (0781-3412-92) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0781-3412-15)
AMPICILLIN SODIUM ampicillin sodium POWDER;INTRAVENOUS 062738 ANDA Sandoz Inc 0781-3413 0781-3413-92 10 VIAL, GLASS in 1 PACKAGE (0781-3413-92) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (0781-3413-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 1GM BASE/VIAL
Approval Date:Feb 19, 1987TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 2GM BASE/VIAL
Approval Date:Feb 19, 1987TE:APRLD:No


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