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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078761

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NDA 078761 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, 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, 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-three 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-nine suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 078761
Tradename:MORPHINE SULFATE
Applicant:Sun Pharm Inds Ltd
Ingredient:morphine sulfate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078761
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 078761
Suppliers and Packaging for NDA: 078761
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 078761 ANDA Ranbaxy Pharmaceuticals Inc. 63304-450 N 63304-450-05
MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 078761 ANDA Ranbaxy Pharmaceuticals Inc. 63304-450 N 63304-450-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:May 11, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:May 11, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:May 11, 2012TE:ABRLD:No

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