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Last Updated: September 22, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022195

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NDA 022195 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, 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, Vintage Pharms Llc, and Meridian Medcl Techn, and is included in fifty-four NDAs. It is available from thirty-five 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 suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 022195
Tradename:MORPHINE SULFATE
Applicant:Hikma
Ingredient:morphine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 022195
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 022195
Suppliers and Packaging for NDA: 022195
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 022195 NDA West-Ward Pharmaceuticals Corp. 0054-0237 0054-0237-41 15 mL in 1 BOTTLE (0054-0237-41)
MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 022195 NDA West-Ward Pharmaceuticals Corp. 0054-0237 0054-0237-49 100 mL in 1 BOTTLE (0054-0237-49)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/5ML
Approval Date:Mar 17, 2008TE:AARLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength20MG/5ML
Approval Date:Mar 17, 2008TE:AARLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/5ML
Approval Date:Jan 25, 2010TE:AARLD:Yes

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