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Cipla
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McKesson
US Army
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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205604

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NDA 205604 describes AMIKACIN SULFATE, which is a drug marketed by Abbott, Emcure Pharms Ltd, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Sagent Pharms, Teva Pharms Usa, and West-ward Pharms Int, and is included in twenty NDAs. It is available from five suppliers. Additional details are available on the AMIKACIN SULFATE profile page.

The generic ingredient in AMIKACIN SULFATE is amikacin sulfate. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.
Summary for 205604
Tradename:AMIKACIN SULFATE
Applicant:Fresenius Kabi Usa
Ingredient:amikacin sulfate
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 205604
Ingredient-typeAminoglycosides
Medical Subject Heading (MeSH) Categories for 205604
Suppliers and Packaging for NDA: 205604
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 205604 ANDA Fresenius Kabi USA, LLC 63323-815 N 63323-815-02
AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 205604 ANDA Fresenius Kabi USA, LLC 63323-815 N 63323-815-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/ML
Approval Date:Dec 9, 2015TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
AstraZeneca
Cerilliant
Boehringer Ingelheim
Accenture
Mallinckrodt
Fish and Richardson
Baxter
McKesson

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