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Serving leading biopharmaceutical companies globally:

Accenture
UBS
McKinsey
US Department of Justice
Cerilliant
Baxter
Fuji
Farmers Insurance
Julphar
AstraZeneca

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201011

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NDA 201011 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, Mallinckrodt Inc, Meridian Medcl Techn, Watson Labs, Fresenius Kabi Usa, Hi-tech Pharmacal, Lannett Holdings 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, Mallinckrodt, Mayne Pharma Inc, Mylan Pharms Inc, Nesher Pharms, Novel Labs Inc, Sun Pharm Inds Ltd, and Sun Pharm Industries, and is included in fifty-three 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 201011
Tradename:MORPHINE SULFATE
Applicant:Nostrum Labs Inc
Ingredient:morphine sulfate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 201011
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 201011
Suppliers and Packaging for NDA: 201011
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 201011 ANDA Nostrum Laboratories, Inc. 70408-358 70408-358-31 100 mL in 1 BOTTLE (70408-358-31)
MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 201011 ANDA Nostrum Laboratories, Inc. 70408-358 70408-358-35 500 mL in 1 BOTTLE (70408-358-35)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/5ML
Approval Date:Feb 5, 2014TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength20MG/5ML
Approval Date:Feb 5, 2014TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Cerilliant
Moodys
Covington
Express Scripts
Fish and Richardson
QuintilesIMS
Deloitte

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