You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Harvard Business School
Express Scripts
Dow
Baxter

Last Updated: April 8, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201947


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 201947 describes MORPHINE SULFATE, which is a drug marketed by Actavis Elizabeth, Impax Labs Inc, Par Pharm Inc, Teva Pharms Usa, Upsher Smith Labs, Hikma, Hospira, Hospira Inc, Icu Medical Inc, Meridian Medcl Techn, Specgx Llc, Watson Labs, Fresenius Kabi Usa, Ani Pharms Inc, Hi Tech, Lannett Co Inc, Nostrum Labs Inc, Paddock Llc, Pharm Assoc, Rhodes Pharms, Tris Pharma Inc, Vistapharm, Dava Pharms Inc, Epic Pharma Llc, Mayne Pharma Inc, Mylan Pharms Inc, Nesher Pharms, Novel Labs Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, and Vintage Pharms Llc, and is included in fifty-four NDAs. It is available from thirty-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. Forty-three suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 201947
Tradename:MORPHINE SULFATE
Applicant:Vistapharm
Ingredient:morphine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201947
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 201947
Suppliers and Packaging for NDA: 201947
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 201947 ANDA VistaPharm, Inc. 66689-032 66689-032-04 100 mL in 1 BOTTLE (66689-032-04)
MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 201947 ANDA VistaPharm, Inc. 66689-032 66689-032-16 500 mL in 1 BOTTLE (66689-032-16)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength10MG/5ML
Approval Date:Jan 5, 2012TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength20MG/5ML
Approval Date:Jan 5, 2012TE:RLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Boehringer Ingelheim
Mallinckrodt
Baxter
Colorcon

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 verification 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.