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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062356

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NDA 062356 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 eighteen 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. Twenty-six suppliers are listed for this compound. Additional details are available on the gentamicin sulfate profile page.
Summary for 062356
Tradename:GENTAMICIN SULFATE
Applicant:Fresenius Kabi Usa
Ingredient:gentamicin sulfate
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 062356
Ingredient-typeAminoglycosides
Suppliers and Packaging for NDA: 062356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GENTAMICIN SULFATE gentamicin sulfate INJECTABLE;INJECTION 062356 ANDA Fresenius Kabi USA, LLC 63323-513 N 63323-513-02

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 10MG BASE/ML
Approval Date:Mar 4, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 40MG BASE/ML
Approval Date:Mar 4, 1982TE:RLD:No

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