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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
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Boehringer Ingelheim

Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204040

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NDA 204040 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 204040
Applicant:Emcure Pharms Ltd
Ingredient:amikacin sulfate
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 204040
Medical Subject Heading (MeSH) Categories for 204040
Suppliers and Packaging for NDA: 204040
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 204040 ANDA Heritage Pharmaceuticals Inc. 23155-290 N 23155-290-42
AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 204040 ANDA Heritage Pharmaceuticals Inc. 23155-290 N 23155-290-41

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/ML
Approval Date:Dec 12, 2013TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Federal Trade Commission
Boehringer Ingelheim
Chinese Patent Office
Cantor Fitzgerald

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