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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062366

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NDA 062366 describes GENTAMICIN SULFATE, which is a drug marketed by Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Perrigo New York, Pharmaderm, Taro, Abbott, Fresenius Kabi Usa, Hospira, Kalapharm, Pharm Spec, Solopak, Teva Parenteral, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Akorn, Perrigo Co Tennessee, Alcon Pharms Ltd, Bausch And Lomb, Paco, Sandoz Inc, B Braun, and Baxter Hlthcare, and is included in thirty-seven NDAs. It is available from twenty suppliers. Additional details are available on the GENTAMICIN SULFATE profile page.

The generic ingredient in GENTAMICIN SULFATE is gentamicin sulfate. There are fifteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 062366
Tradename:GENTAMICIN SULFATE
Applicant:Fresenius Kabi Usa
Ingredient:gentamicin sulfate
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 062366
Ingredient-typeAminoglycosides
Suppliers and Packaging for NDA: 062366
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GENTAMICIN SULFATE gentamicin sulfate INJECTABLE;INJECTION 062366 ANDA General Injectables & Vaccines, Inc 52584-010 N 52584-010-20
GENTAMICIN SULFATE gentamicin sulfate INJECTABLE;INJECTION 062366 ANDA Cardinal Health 55154-9376 E 55154-9376-5

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML
Approval Date:Aug 4, 1983TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Feb 6, 1986TE:APRLD:No

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