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Serving leading biopharmaceutical companies globally:

Medtronic
Cipla
Queensland Health
Colorcon
Boehringer Ingelheim
Dow
Julphar
Citi
Cerilliant
Harvard Business School

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203323

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NDA 203323 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 203323
Tradename:AMIKACIN SULFATE
Applicant:Sagent Pharms
Ingredient:amikacin sulfate
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 203323
Ingredient-typeAminoglycosides
Medical Subject Heading (MeSH) Categories for 203323
Suppliers and Packaging for NDA: 203323
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 203323 ANDA Sagent Pharmaceuticals 25021-173 N 25021-173-04
AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 203323 ANDA Sagent Pharmaceuticals 25021-173 N 25021-173-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/ML
Approval Date:May 12, 2016TE:APRLD:No

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Cantor Fitzgerald
Express Scripts
Merck
Citi
Daiichi Sankyo
UBS
Harvard Business School
Cipla
Covington

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