.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204040

« Back to Dashboard
NDA 204040 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: 204040

Tradename:
AMIKACIN SULFATE
Applicant:
Emcure Pharms Ltd
Ingredient:
amikacin sulfate
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 204040

Ingredient-typeAminoglycosides

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 23155-290-41 10 VIAL, GLASS in 1 CARTON (23155-290-41) > 2 mL in 1 VIAL, GLASS (23155-290-31)
AMIKACIN SULFATE
amikacin sulfate
INJECTABLE;INJECTION 204040 ANDA Heritage Pharmaceuticals Inc. 23155-290 23155-290-42 10 VIAL, GLASS in 1 CARTON (23155-290-42) > 4 mL in 1 VIAL, GLASS (23155-290-32)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/ML
Approval Date:Dec 12, 2013TE:APRLD:Yes


Complete Access Available with Subscription
« Back to Dashboard

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

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.

`abc