Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 13, 2019

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 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 Inc, Sandoz, Watson Labs Inc, and West-ward Pharms Int, and is included in twenty-five NDAs. It is available from sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium profile page.
Summary for 065499
Tradename:AMPICILLIN SODIUM
Applicant:Aurobindo Pharma
Ingredient:ampicillin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065499
Medical Subject Heading (MeSH) Categories for 065499
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 General Injectables and Vaccines, Inc. 52584-082 52584-082-10 1 VIAL in 1 BAG (52584-082-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
AMPICILLIN SODIUM ampicillin sodium INJECTABLE;INJECTION 065499 ANDA General Injectables and Vaccines, Inc. 52584-114 52584-114-20 1 VIAL in 1 BAG (52584-114-20) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Profile for product number 001

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

Profile for product number 002

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

Profile 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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