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BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
Citi
Daiichi Sankyo
Moodys
Johnson and Johnson
Colorcon
Fuji
Argus Health
Julphar

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205014

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NDA 205014 describes NALOXONE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Akorn, Astrazeneca, Eurohlth Intl Sarl, Hospira, Igi Labs Inc, Intl Medication, Marsam Pharms Llc, Mylan Institutional, Smith And Nephew, Solopak, Somerset Theraps Llc, Watson Labs, Gavis Pharms, and Sun Pharm Inds Ltd, and is included in forty-nine NDAs. It is available from thirteen suppliers. Additional details are available on the NALOXONE HYDROCHLORIDE profile page.

The generic ingredient in NALOXONE HYDROCHLORIDE is naloxone hydrochloride; pentazocine hydrochloride. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.

Summary for 205014

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 205014

Mechanism of ActionOpioid Antagonists

Suppliers and Packaging for NDA: 205014

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 205014 ANDA Mylan Institutional LLC 67457-299 67457-299-10 10 VIAL, MULTI-DOSE in 1 CARTON (67457-299-10) > 10 mL in 1 VIAL, MULTI-DOSE (67457-299-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.4MG/ML
Approval Date:Jun 29, 2016TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Cipla
Farmers Insurance
Moodys
McKinsey
Healthtrust
Dow
Teva
Merck
Chubb
QuintilesIMS

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.

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