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US Department of Justice
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Generated: June 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203849

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NDA 203849 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, 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, Sun Pharm Industries, and Vintage Pharms Llc, and is included in fifty-four NDAs. It is available from forty-nine 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-five suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 203849
Tradename:MORPHINE SULFATE
Applicant:Actavis Elizabeth
Ingredient:morphine sulfate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 203849
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 203849
Suppliers and Packaging for NDA: 203849
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 203849 ANDA Actavis Pharma, Inc. 0228-4270 N 0228-4270-11
MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 203849 ANDA Actavis Pharma, Inc. 0228-4270 N 0228-4270-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Apr 6, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Apr 6, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Apr 6, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Fish and Richardson
Argus Health
Merck
US Army
Queensland Health
Express Scripts
Medtronic
Mallinckrodt

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