Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

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

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Queensland Health
Chinese Patent Office

Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016619

« Back to Dashboard

NDA 016619 describes SUBLIMAZE PRESERVATIVE FREE, which is a drug marketed by Akorn and is included in one NDA. It is available from one supplier. Additional details are available on the SUBLIMAZE PRESERVATIVE FREE profile page.

The generic ingredient in SUBLIMAZE PRESERVATIVE FREE is fentanyl citrate. There are thirty-one drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
Summary for 016619
Ingredient:fentanyl citrate
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 016619
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 016619
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUBLIMAZE PRESERVATIVE FREE fentanyl citrate INJECTABLE;INJECTION 016619 NDA Akorn, Inc. 17478-030 N 17478-030-10
SUBLIMAZE PRESERVATIVE FREE fentanyl citrate INJECTABLE;INJECTION 016619 NDA Akorn, Inc. 17478-030 N 17478-030-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo
Harvard Business School
Boehringer Ingelheim

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.