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Generated: October 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204223

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NDA 204223 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-three NDAs. It is available from forty-six 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-three suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 204223
Tradename:MORPHINE SULFATE
Applicant:Fresenius Kabi Usa
Ingredient:morphine sulfate
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 204223
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 204223
Suppliers and Packaging for NDA: 204223
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223 NDA Fresenius Kabi USA, LLC 63323-451 63323-451-01 25 VIAL, SINGLE-DOSE in 1 BOX (63323-451-01) > 1 mL in 1 VIAL, SINGLE-DOSE (63323-451-00)
MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223 NDA Fresenius Kabi USA, LLC 63323-452 63323-452-01 25 VIAL, SINGLE-DOSE in 1 BOX (63323-452-01) > 1 mL in 1 VIAL, SINGLE-DOSE (63323-452-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, INTRAVENOUSStrength2MG/ML (2MG/ML)
Approval Date:Oct 30, 2013TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 12, 2034Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Mar 12, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
Patent:➤ Sign UpPatent Expiration:Mar 12, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PAIN

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