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Generated: August 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065499

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NDA 065499 describes AMPICILLIN SODIUM, which is a drug marketed by Istituto Bio Ita Spa, Watson Labs Inc, Mylan Labs Ltd, Intl Medication, Consolidated Pharm, Sandoz, Hanford Gc, Antibiotice, Apothecon, Hospira Inc, Lilly, Sagent Pharms, Acs Dobfar Spa, West-ward Pharms Int, and Aurobindo Pharma, and is included in thirty-two 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 NDA: 065499

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

Pharmacology for NDA: 065499

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 065499

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMPICILLIN SODIUM
ampicillin sodium
INJECTABLE;INJECTION 065499 ANDA AuroMedics Pharma LLC 55150-111 55150-111-10 10 VIAL in 1 BOX (55150-111-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
AMPICILLIN SODIUM
ampicillin sodium
INJECTABLE;INJECTION 065499 ANDA AuroMedics Pharma LLC 55150-112 55150-112-10 10 VIAL in 1 BOX (55150-112-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 125MG BASE/VIAL
Approval Date:Aug 17, 2010TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL
Approval Date:Aug 17, 2010TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Aug 17, 2010TE:APRLD:No


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