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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076720

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NDA 076720 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 076720
Tradename:MORPHINE SULFATE
Applicant:Nesher Pharms
Ingredient:morphine sulfate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 076720
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 076720
Suppliers and Packaging for NDA: 076720
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 076720 ANDA ETHEX Corporation 58177-320 58177-320-11 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (58177-320-11)
MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 076720 ANDA ETHEX Corporation 58177-320 58177-320-04 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-320-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:May 19, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Dec 23, 2005TE:ABRLD:No

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Moodys
Merck
Deloitte

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