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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205605

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NDA 205605 describes AMIKACIN SULFATE, which is a drug marketed by Fresenius Kabi Usa, West-ward Pharms Int, Sagent Pharms, Emcure Pharms Ltd, Teva Pharms Usa, Hospira, Abbott, and Igi Labs Inc, 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 NDA: 205605

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 205605

Ingredient-typeAminoglycosides

Suppliers and Packaging for NDA: 205605

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIKACIN SULFATE
amikacin sulfate
INJECTABLE;INJECTION 205605 ANDA Fresenius Kabi USA, LLC 63323-816 63323-816-02 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-816-02) > 2 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Dec 9, 2015TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Cantor Fitzgerald
Citi
Cipla
Merck
Fuji
Argus Health
McKinsey
Fish and Richardson
Daiichi Sankyo

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