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

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
US Department of Justice

Generated: August 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206127

« Back to Dashboard

NDA 206127 describes EPTIFIBATIDE, which is a drug marketed by Accord Hlthcare, Akorn, Amneal Pharms, Aurobindo Pharma Ltd, Mylan Labs Ltd, Sagent Pharms, and Teva Pharms Usa, and is included in eight NDAs. It is available from eight suppliers. Additional details are available on the EPTIFIBATIDE profile page.

The generic ingredient in EPTIFIBATIDE is eptifibatide. There are fifteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.
Summary for 206127
Applicant:Aurobindo Pharma Ltd
Formulation / Manufacturing:see details
Pharmacology for NDA: 206127
Physiological EffectDecreased Platelet Aggregation
Suppliers and Packaging for NDA: 206127
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 206127 ANDA AuroMedics Pharma LLC 55150-218 N 55150-218-99
EPTIFIBATIDE eptifibatide INJECTABLE;INJECTION 206127 ANDA AuroMedics Pharma LLC 55150-219 N 55150-219-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Dec 8, 2015TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength75MG/100ML
Approval Date:Dec 8, 2015TE: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:

Farmers Insurance
Argus Health

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.