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

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Mallinckrodt
Federal Trade Commission
Cantor Fitzgerald
QuintilesIMS
Healthtrust
Covington
Farmers Insurance
Cipla

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203519

« Back to Dashboard

NDA 203519 describes MORPHINE SULFATE, which is a drug marketed by Actavis Elizabeth, Impax Labs Inc, Par Pharm Inc, Teva Pharms Usa, Upsher-smith Labs, Eurohlth Intl Sarl, Hospira, Hospira Inc, Icu Medical Inc, Meridian Medcl Techn, Specgx Llc, Watson Labs, Fresenius Kabi Usa, Ani Pharms Inc, Hi-tech Pharmacal, Lannett Co Inc, Nostrum Labs Inc, Paddock Llc, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vintage Pharms Llc, Vistapharm, West-ward Pharms Int, Dava Pharms Inc, Epic Pharma Llc, Mayne Pharma Inc, Mylan Pharms Inc, Nesher Pharms, Novel Labs Inc, Sun Pharm Inds Ltd, and Sun Pharm Industries, and is included in fifty-four NDAs. It is available from forty-eight suppliers. There are three patents protecting this drug. Additional details are available on the MORPHINE SULFATE profile page.

The generic ingredient in MORPHINE SULFATE is morphine sulfate. There are twenty-three drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 203519
Tradename:MORPHINE SULFATE
Applicant:Tris Pharma Inc
Ingredient:morphine sulfate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 203519
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 203519
Suppliers and Packaging for NDA: 203519
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 203519 ANDA Tris Pharma Inc 27808-083 N 27808-083-01
MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 203519 ANDA Tris Pharma Inc 27808-083 N 27808-083-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength20MG/5ML
Approval Date:May 18, 2016TE:AARLD: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:

US Army
Covington
Medtronic
Queensland Health
Julphar
US Department of Justice
UBS
Citi
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.