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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076438

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NDA 076438 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, 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, Vintage Pharms Llc, and Hikma, and is included in fifty-four NDAs. It is available from thirty-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. Forty-three suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 076438
Tradename:MORPHINE SULFATE
Applicant:Specgx Llc
Ingredient:morphine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076438
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 076438
Suppliers and Packaging for NDA: 076438
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 076438 ANDA SpecGx LLC 0406-8320 0406-8320-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-8320-01)
MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 076438 ANDA SpecGx LLC 0406-8390 0406-8390-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-8390-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Jul 3, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Jul 3, 2003TE:ABRLD:No

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