Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Express Scripts
Mallinckrodt
Baxter
Merck
Teva
Deloitte
Harvard Business School
QuintilesIMS

Generated: December 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203323

« Back to Dashboard

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. Six 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 203323
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 25021-173-02 10 VIAL in 1 CARTON (25021-173-02) > 2 mL in 1 VIAL
AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 203323 ANDA Sagent Pharmaceuticals 25021-173 25021-173-04 10 VIAL in 1 CARTON (25021-173-04) > 4 mL in 1 VIAL

Profile for product number 001

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Argus Health
Fuji
Cerilliant
Baxter
McKesson
Federal Trade Commission
US Department of Justice
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.